THE EFFECT OF EXERCISE TRAINING ON SLEEP QUALITY IN HEART FAILURE Jessica Mary Suna Bachelor of Nursing, Bachelor of Applied Science (Human Movement Studies), Graduate Certificate in Clinical Trial Management Submitted in fulfilment of the requirements for the degree of Master of Health (Research) School of Exercise and Nutrition Sciences Faculty of Health Queensland University of Technology May 2013
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THE EFFECT OF EXERCISE TRAINING ON
SLEEP QUALITY IN HEART FAILURE
Jessica Mary Suna
Bachelor of Nursing, Bachelor of Applied Science (Human Movement Studies), Graduate Certificate in Clinical Trial
Management
Submitted in fulfilment of the requirements for the degree of
Abstract ................................................................................................................................................. iii
Table of Contents ....................................................................................................................................v
List of Figures ...................................................................................................................................... vii
List of Tables ...................................................................................................................................... viii
List of Abbreviations..............................................................................................................................ix
Statement of Original Authorship ..........................................................................................................xi
Presentations and Awards .................................................................................................................... xii
Acknowledgements ............................................................................................................................. xiii
CHAPTER 1: LITERATURE REVIEW ...........................................................................................1
2.3 Instruments.................................................................................................................................27 2.3.1 Measurement of Primary Outcome.................................................................................28 2.3.2 Measurement of Potential Mediating Variables..............................................................29 2.3.3 Measurement of Dose of Exercise ..................................................................................30
2.4 Procedure and Timeline .............................................................................................................30
2.5 Interventions ..............................................................................................................................30 2.5.1 DMP plus standard exercise advice (Control) ................................................................30 2.5.2 DMP plus supervised exercise programme (Intervention)..............................................31
3.3 Intervention Effects on Sleep Quality ........................................................................................42
3.4 Effect of Exercise Dose on Sleep Quality..................................................................................45 3.4.1 Adherence to Intervention ..............................................................................................45 3.4.2 Adherence to Physical Activity Guidelines ....................................................................45
vi
3.5 Effect of Potential Mediators of Change in Sleep......................................................................47
3.6 Effect of Baseline Sleep Quality on Exercise Adherence ..........................................................50
4.1 Relationship With Previous Studies...........................................................................................53 4.1.1 Exercise Effects on Subjective Measures of Sleep .........................................................54 4.1.2 Potential Mediators of Improvement in Sleep ................................................................55 4.1.3 Other Mediators of Change ............................................................................................58
4.2 Implications for Clinical Practice ..............................................................................................59
4.3 Study Limitations and Strengths................................................................................................60
4.4 Directions for Future Research ..................................................................................................62
Figure 4. Proportion of scheduled exercise classes attended. ...............................................................40
Figure 5.Correlation between change in sleep quality and change in depression following Intervention ..........................................................................................................................47
Figure 6. Correlation between change in sleep quality and change in BMI following Intervention ..........................................................................................................................48
Figure 7. Correlation between change in sleep quality and change in 6 minute walk distance following Intervention..........................................................................................................48
viii
List of Tables
Table 1.1 Details of Studies Included in Literature Review ..................................................................14
Table 3.1 Baseline Characteristics of Study Participants by Intervention Group ................................39
Table 3.2 Baseline Characteristics of Participants in the Intervention Group Who Were Adherent versus Non-Adherent with Exercise Classes.........................................................41
Table 3.3 Proportion of Patients with a Clinically Significant Change in Sleep Quality According to Intervention Group .........................................................................................43
Table 3.4 Change in Sleep Quality by Intervention Group ...................................................................44
Table 3.5 Proportion of Patients with a Clinically Significant Change in Sleep Quality by Adherence with Physical activity guidelines ........................................................................46
Table 3.6 Change in Potential Mediating Variables According To Intervention Group .....................49
Table 3.7 General Linear Models of Change in Global PSQI from Baseline to Month 3 to Compare Control with Intervention with Adjustment for Covariates ..................................49
Table 3.8 Baseline Characteristics of Participants with Good (Global PSQI <5) or Poor (Global PSQI ≥5) Sleep Quality at Baseline ........................................................................51
Table 3.9 Adherence to Intervention (≥67% classes) According to Baseline Sleep Quality ................51
ix
List of Abbreviations
AACVPR American Association of Cardiovascular and Pulmonary Rehabilitation ACE-I Angiotensin converting enzyme inhibitor ACSM American College of Sports Medicine ANOVA One way analysis of variance AHI Apnoea hypopnoea index ARB Angiotensin receptor blocker ATS American Thoracic Society AV Atrioventricular BMI Body mass index CBT Cognitive Behavioural Therapy CI Confidence Interval CPAP Continuous positive air pressure CRT Cardiac Resynchronisation Therapy CSA Central sleep apnoea DEXA Dual Energy X-ray Absorptiometry DMP Disease management programme ECG Electrocardiograph EF Ejection fraction EJECTION: HF Exercise Joins Education Combined Therapy to Improve Outcomes in Newly discharged Heart Failure ESS Epworth Sleepiness Scale FITT Frequency, intensity, time, type GDS Geriatric Depression Scale GLM General Linear Model HF Heart failure HR Heart rate HREC Human research ethics committees ICH-GCP International Conference on Harmonisation – Good Clinical Practice IQR Inter Quartile range ITT Intention to Treat KG Kilogram LV Left Ventricular LVEF Left Ventricular Ejection Fraction NHF National Heart Foundation NHMRC National Health and Medical Research Council NYHA New York Heart Association OSA Obstructive sleep apnoea PA Physical Activity PI Pacific Islander PLMD Periodic limb movement disorder PSG Polysomnography PSQI Pittsburgh Sleep Quality Index QLD Queensland QOL Quality of Life
x
RCT Randomised controlled trial RIP Rest in Peace RLS Restless legs syndrome RPE Rating of perceived exertion SD Standard deviation SDB Sleep disordered breathing SOL Sleep onset latency 6MWT Six minute walk test SPSS Statistical Package for Social Science sTNF-R Soluble tumour necrosis factor-alpha receptor TNF-α Tumour necrosis factor-alpha TSI Torres Strait Islander VO2 Maximal oxygen consumption
xi
Statement of Original Authorship
The work contained in this thesis has not been previously submitted to meet
requirements for an award at this or any other higher education institution. To the
best of my knowledge and belief, the thesis contains no material previously
published or written by another person except where due reference is made.
Signature:
Date: ____8th May 2013_________
xii
Presentations and Awards
Conference Papers
Suna, J. M., Scott, A., Stewart, I., & Mudge, A. (2012). The effect of exercise on sleep quality in heart failure. Paper presented at the European Society of Cardiology Heart Failure Congress 2012, Belgrade, Serbia. http://www.escardio.org/congresses/hf2012/pages/welcome.aspx
Awards
Best clinical poster award, Royal Brisbane and Women's Hospital Healthcare
Symposium, 10-14th October 2011.
Young investigator award and first prize nursing investigator session, European
Society of Cardiology Heart Failure Congress 2012, 19-22 May 2012.
xiii
Acknowledgements
I would like to thank my Principal Supervisor Prof Adam Scott and Associate
Supervisors Prof Ian Stewart and Prof Alison Mudge for their patience,
encouragement and guidance over the past three years. Many thanks also to the
EJECTION:HF study investigators including Prof Alison Mudge (Principal
Investigator), Dr Adam Scott, A/Prof Charles Denaro, Dr George Javorsky, A/Prof
John Atherton, Julie Adsett, Paul Scuffham, Prof Peter O’Rourke and Robert Mullins
whose drive to improve the lives of patients with heart failure enabled this project.
This project would not have been possible without the commitment of the heart
failure clinicians across the Queensland who assisted with the project.
Royal Brisbane and Women’s Hospital: Linda Prentice (Clinical Nurse
Consultant), Carlos Fernandez (Clinical Nurse), Sophie Lloyd (Clinical Nurse), Julie
Adsett (Physiotherapist) and Robert Mullins (Clinical Exercise Physiologist).
The Prince Charles Hospital Heart Failure Service: Maria Podger (Clinical
Nurse Consultant), Anna Bunn (Clinical Nurse), Amy Bullen (Physiotherapist) and
Study group 1 (n=8): 3 months @ 2/week 1 hour Tai Chi Control group (n=10): Usual care
Study group: Significant increase in high-frequency coupling (stable sleep) + reductions in low-frequency coupling (unstable sleep) (p=0.04 and p<0.01) Improved exercise capacity (mean 76m) (p<0.01) and QOL (p<0.01). Significant correlation between QOL and sleep stability (increased high-frequency coupling associated with better QOL)
Retrospective design Small sample size Use of sleep spectrogram
(Gary & Lee, 2007)
RCT to test effects of home-based exercise on sleep
23 women with stable diastolic HF (EF>= 45%)
1) Sleep (actigraphy + sleep diary) (2) Physical function (6MWT) (3) QOL (MLHFQ) (4) Depression (GDS)
Study group (n=13): 3 months @ 3/week Self-monitored graded outdoor walking Control group (n=10): 12 week 1/week educational home visit
Study group: Significant increase in TST (p<0.01) Improved QOL (p<0.05)
Study undertaken in often under-represented population
Small sample Female only Confounding SQ not measured SA not diagnosed
Study group (n=10): 6 months @ 3/week 1 hour cycling/ walking Control group (n=8): Usual care (patients who did not agree to participate in exercise program)
Study group: BNP decreased significantly (p<0.05) BMI did not change AHI significantly decreased (p<0.01) CSA decreased (p<0.01) OSA unchanged Significant improvement in arterial oxygen saturation (p<0.05) Increased peak V02 (p<0.05) Decrease in the VEVC02 slope (p<0.01)
First study to show aerobic exercise improved exercise capacity & ameliorated breathing abnormalities in HF patients.
Majority male No control group Small sample No specialised exercise staff
(Ueno et al., 2009)
Cross over case control study to test effects of exercise on sleep + neurovascular control
Study group (n=24): 4 months no training (control) followed by 4 months @ 3/week 60 min aerobic/ resistance exercise Healthy age matched control group (n=9): 4 months @ 3/week 60 min aerobic/ resistance exercise
Study group: Increased functional class Improved peak V02 Reduced MSNA (higher in HF + OSA/CSA) Patients with HF + OSA Increased stage 3-4 sleep + oxygen saturation Decreased arousals + AHI
Excluded DM + high BMI patients Finapres not reliable
Study group 1 (n=18): 3 months daily recommended home aerobic training Study group 2 (n=18); 3 months daily recommended home aerobic + strength training Study group 3 ( n=14): untrained
Decreased AHI (group 1+2). Group 1 decrease in hypopnoea. Group 2 decrease apnoea and hypopnoea. Both groups exhibited decreased number of nocturnal arousals and increased sleep efficiency.
Generalisablity of sample – many patients not able to safely exercise at home Reliance on self monitoring - ? compliance
(P. Duarte Freitas et al., 2011)
Cohort study to evaluate impact of card rehabilitation program on physical parameters & QOL of cardiac patients.
101 cardiac patients
1) Anthropometry 2) QOL 3) SF-36 4) HADS 5) PSQI
1 month @ 5/week @ 3 hours per day cardiac rehabilitation program
25% improvement in sleep quality 29% decrease in anxiety 32% decrease in depression Weight loss associated with decreased anxiety Improved SQ related to mental health state
Short duration of intervention
Multi-factorial program =? effect of other parts of program on sleep (medications, nutrition, psychological support)
Chapter 1: Literature Review 17
Effect of Exercise on Subjective Measures of Sleep
One article which met review criteria examined the relationship between
exercise and subjective (self-reported) sleep variables. In this recent study by
Duarte Freitas et al (P. Duarte Freitas, et al., 2011) a 25% improvement in global
sleep quality (p<0.001) was identified following an intensive four-week, in-patient
cardiac rehabilitation program (P Duarte Freitas et al., 2011). These findings are
consistent with previous investigations regarding the effect of exercise on sleep
quality in other populations (Afshar, et al., 2011; Arcos-Carmona, et al., 2011;
Caldwell, Harrison, Adams, & Triplett, 2009; K. M. Chen et al., 2009; K. M. Chen
et al., 2010; M. C. Chen, Liu, Huang, & Chiou, 2012; de Castro Toledo Guimaraes,
et al., 2008; King, et al., 1997; King et al., 2008; Kline et al., 2011; Li et al., 2004;
Reid et al., 2010; Richards et al., 2011; Sprod, et al., 2010; Tang, et al., 2010;
Tworoger et al., 2003). In this cohort study of 101 patients referred for cardiac
rehabilitation at Clinique Saint-Orens France, participants completed daily aerobic
exercise of 2-3 hours duration including 45 minutes of ergo cycle or treadmill, 1
hour of walking outside plus a variety of sessions including fitness, gymnastics,
relaxation, Qi Gong and aquatic training. Further to improvements in sleep quality
the study identified significant improvements in quality of life, anxiety and
depression after the rehabilitation program. While this study lacked a control
group it provided a much larger sample size than any other investigation on the topic
in this population group. It is difficult to ascertain however, which component of
this comprehensive program produced improvements in sleep, as a variety of
exercise interventions were offered. Furthermore, this program which was offered
to patients with a number of different cardiac conditions involved optimising
medical therapy, controlling cardiovascular risk factors, diet monitoring, education
and psychological support. The improvements in sleep quality, depression and QOL
identified may have been attributable to the other interventions described above.
While this study produced significant improvements in sleep, replication of the
study would be difficult in our current health care system given the costs associated
with an intensive in-patient treatment over a four week period.
18
Effect of Exercise on Objective Measures of Sleep
The majority of studies included in the review examined the effect of exercise
on objective measures of sleep. These studies were undertaken in stable systolic HF
patients with existing sleep complaints, with one investigation completed in women
with diastolic HF. Study interventions included bicycle ergometer, walking,
strength training and Tai Chi. Study durations ranged from 3 to 6 months. The
majority of interventions were conducted three times a week. Study designs also
differed; two studies used a case control design, two were randomised controlled
trials and the last involved a retrospective review of data collected in a randomised
controlled trail (RCT).
Evidence from these studies suggests objective measures of sleep are also
optimised following exercise programs in persons with HF. Yamamoto and
colleagues (Yamamoto, et al., 2007) enrolled 18 stable systolic HF patients with
demonstrated SDB on cardiorespiratory polygraphy. Of the 18 participants recruited
to the study, 10 agreed to participate in an exercise intervention and the remaining 8
served as controls. The exercise intervention consisted of 6 months of aerobic
exercise in the form of walking or cycling 3 times per week. The number of
quantified respiratory events per hour of sleep time, commonly known as the apnoea
hypopnoea index (AHI), was significantly decreased in the exercise group (p<0.01),
with reduction in central but not obstructive apnoea events. Exercise was also
shown to increase oxygen levels during sleep (p<0.05). This study was limited by
its small sample size, case control design and lack of specialist exercise supervision.
In contrast to the findings of Yamamoto, Ueno and colleagues found that
exercise reduced the AHI and improved oxygen saturation during sleep only in the
subgroup with co-existing OSA (Ueno, et al., 2009). This prospective cohort study
examined 24 stable HF patients before and after a 4 month exercise intervention (3
times per week aerobic and resistance exercise), compared to 9 subjects without HF.
Heart failure participants were further grouped according to results of PSG into
OSA, or no sleep apnoea. Those with OSA also tended to have increased levels of
deep, stage 3-4 sleep following exercise. This study was also limited by its small
Chapter 1: Literature Review 19
sample size and lack of randomised controlled design. Furthermore, Ueno and
colleagues excluded patients with diabetes mellitus and overweight individuals
(Ueno, et al., 2009). As 30% of patients with HF also suffer from diabetes and
many are overweight, it is difficult to apply these results to the usual HF population
(Ueno, et al., 2009).
Likewise to the findings of Ueno and colleagues, Yeh et al identified an
increase in stable sleep (p=0.04) in their retrospective analysis of ECG-based sleep
spectography. This trial involved 12 weeks of Tai Chi exercise in 18 patients with
stable systolic HF (Yeh, Mietus, et al., 2008; Yeh, Wayne, & Phillips, 2008). This
study is limited by its use of retrospective analysis of data and the use of 24 hour
continuous ECG data to measure sleep rather than polysomnography which would
have allowed deeper review of sleep stages. The sample size of this study was small
and like other studies, was unable to clarify which part of the exercise intervention
was responsible for improvements in sleep.
In an examination of the effect of home-based exercise for patients with HF
and sleep apnoea, a significant decrease in AHI was identified following exercise
(Servantes, et al., 2012). In this study, the 50 participants were randomly allocated
to one of three groups; aerobic training (n=18), aerobic with strength training (n=18)
and untrained (n=14). Participants were provided with three supervised sessions
then were instructed to exercise in their homes for three months and were monitored
weekly by telephone. Aerobic exercise was found to decrease hypopnoea events
while aerobic exercise with the addition of strength training decreased both apnoea
and hypopnoea events. Nocturnal arousals decreased in both groups and this was
associated with a significant increase in sleep efficiency. Limitations of this study
relate to sample generalisablity with almost 85% of patients screened for inclusion,
not eligible for study inclusion. Another study limitation involves the use of self-
report for exercise adherence therefore it is not possible to confirm the extent to
which the individual complied with the exercise regime.
20
Gary and Lee (Gary & Lee, 2007) randomly allocated 23 women with stable
diastolic HF to a 12 week program of thrice weekly, self-monitored graded outdoor
walking or an attention control group of weekly home-based education (Gary & Lee,
2007). While these investigators were unable to identify a significant difference in
study outcomes between women in the walking group and education group,
increased sleep duration documented by actigraphy by observed in exercise
participants (p<0.01) following intervention. This study was limited by its small
sample size and lack of an objective measure of sleep thus investigators were unable
to confirm whether existing sleep disturbance contributed to results. Further
limitations involve the use of an un-standardized questionnaire to measure sleep
quality and a lack of measurement of potential confounding factors such as the effect
of light exposure.
Potential Mediators of Improvement in Sleep
These investigations highlight several potential moderators of sleep
enhancement. Improvements in sleep appeared to be associated with reductions in
anxiety and depression (P. Duarte Freitas, et al., 2011), improved quality of life
(Gary & Lee, 2007; Yeh, Mietus, et al., 2008) and increased exercise capacity
(Servantes, et al., 2012; Yeh, Mietus, et al., 2008).
Effect of Exercise Frequency, Intensity, Time and Type
This review of the literature highlights a lack of clarity regarding the most
effective form of exercise intervention for improvement in sleep quality and many
questions remain regarding the optimal frequency, intensity, timing and type of
exercise required to elucidate improvements in sleep. Previous investigators have
suggested that a u-shaped association exists between exercise and sleep with
insufficient exercise and very high amounts of exercise appearing to have
unfavourable effects on sleep (S. D. Youngstedt, 2005). This theory however is
refuted by Kline and colleagues who later report that even low doses of exercise
significantly decrease the odds of sleep disturbance (Kline et al., 2012). While an
acute episode of exercise has been found to have a favourable effect on sleep there is
greater support of the effects of habitual exercise in improving sleep (Uchida et al.,
Chapter 1: Literature Review 21
2012; S. D. Youngstedt, 2005). This may be because chronic exercise is needed to
bring about changes in body composition, basic metabolic rate, cardiac function,
glycaemic control, and immune function (Pedersen, 2006).
A team of researchers in Finland have proposed that there is no relationship
between exercise intensity or duration and sleep quality (Myllymaki et al., 2012). In
another study however, moderate intensity exercise was suggested to be the most
effective in improving symptoms associated with poor sleep (Uchida, et al., 2012; S.
D. Youngstedt, 2005). Question also remains regarding the most effective form of
exercise for sleep improvement however it appears that the greatest evidence lies
with aerobic exercise interventions. More recent studies have examined the effects
of yoga, Tai Chi and resistance exercise and appear to show favorable results,
although greater evidence is required to confirm these findings.
1.3 SUMMARY AND IMPLICATIONS
This review of the literature suggests that there may be a role of exercise in
improving a range of sleep disturbances in HF. This theory is supported by the
positive effect of exercise on measures of sleep identified in other populations.
Although these studies are small, they report favourable effects of exercise on
several sleep parameters. Exercise training in HF patients appears to lead to an
increased proportion of stable, deep sleep (Ueno, et al., 2009; Yeh, Mietus, et al.,
2008) and may reduce the severity of sleep apnoea independent of body weight
changes (Ueno, et al., 2009; Yamamoto, et al., 2007).
While existing literature is promising, interpretation and synthesis of the
results is limited by methodological issues. This may explain the lack of comment
regarding the beneficial effects of exercise on sleep quality in current heart failure
guidelines ("Australia's health 2012," 2012). Studies used a range of exercise
interventions (varying by type, timing, frequency, intensity and duration) and few
reported adherence levels. Many of the studies were not randomised and few of the
controlled studies used an attention control. Studies also employed a range of
22
outcomes and measures, and the relationship between objective measures of sleep
(sleep architecture, sleep disordered breathing), subjective sleep quality and
sleepiness, and objective measures of daytime functional impairment remains
unclear. Finally, the way in which exercise influences its sleep enhancing effects
was not confirmed and many confounding factors or alternative explanations are
evident.
Further investigation is therefore required to confirm the beneficial effect of
exercise in this population. To ensure the success of these investigations several
important design aspects need to be met. Firstly, future studies should be adequately
powered and use a randomised controlled design. It is equally important the
population enrolled adequately reflects that population to which the intervention
applies. Studies should also examine subjective sleep measures because poor sleep
quality may be an important symptom of an underlying sleep or medical disorder
(Buysse, Reynolds, Monk, Berman, & Kupfer, 1989). Furthermore, an outcome of
improved sleep carries a real meaning for patients and is likely to improve
compliance with exercise regimes. While difficult, it is also important that efforts be
made to clarify the mechanism by which exercise exerts its sleep promoting effects.
Lastly, studies should also examine the best form of exercise intervention in terms of
frequency, intensity, time and type of exercise.
In conclusion these findings suggest that exercise has the potential to improve
several objective and subjective measures of sleep in patients with HF. Evidence
suggests that improvements in sleep quality coincide with improvements in sleep
pattern and breathing, quality of life, anxiety and depression, exercise performance
and body composition. This information may be valuable for patients and their
healthcare providers in motivating exercise participation. Further well-conducted
studies are also required to further elucidate mechanisms of sleep improvement and
interrelationships between physiological, subjective and functional sleep variables.
Chapter 1: Literature Review 23
1.4 STUDY AIM
An examination of the literature highlighted a number of issues with treatment
for sleep disorders in patients with HF. Exercise programs were identified as a
potential solution given their role in good sleep hygiene in other populations and in
light of the positive research evidence identified in small studies of patients with HF
2010). A study of the effect of exercise on sleep quality in HF was important
because the effect of such programs on sleep quality in HF was not known (Flynn, et
al., 2009; O'Connor, et al., 2009). An outcome of subjective sleep quality was
chosen because it is often the individual’s perception of their sleep state which
motivates them to seek treatment. This outcome was also selected in light of the
high costs and access issues associated with polysomnography.
The primary aim of this study was therefore to examine the effect of a
supervised, hospital-based aerobic and resistance exercise program in addition to a
standard HF DMP on (1) clinical change (≥3 points) in global Pittsburgh Sleep
Quality Index (PSQI) score; (2) change in component and global PSQI score and;
(3) change in sleep category (good/poor).
Secondary aims were to examine;
The effect of dose of exercise on clinical change (≥3 points) in global
Pittsburgh Sleep Quality Index (PSQI) score;
The effect of potential mediators of improvement in sleep including
depression, exercise performance and body mass index (BMI) and;
The effects of baseline sleep quality on exercise adherence.
1.5 STUDY HYPOTHESIS
1.5.1 Primary Hypothesis
The primary hypothesis of the study was that a 3 month program of supervised,
hospital-based exercise training will produce greater clinically significant
improvement in subjective sleep quality when compared to a standard HF DMP.
24
1.5.2 Secondary Hypothesis
1. Increased dose of exercise is related with greater clinical improvement in
sleep quality.
2. Improvements in sleep quality as measured by change in global PSQI score
are mediated by improvements in depression as measured by the change in Geriatric
Depression Scale (GDS) between Baseline and Month 3.
3. Improvements in sleep quality as measured by change in global PSQI score
are mediated by improvements in exercise performance as measured by change in
six minute walk test (6MWT) distance between Baseline and Month 3.
4. Improvements in sleep quality as measured by change in global PSQI score
are mediated by a reduction in BMI between Baseline and Month 3.
5. Poor baseline sleep quality is related with reduced adherence to intervention
and reduced adherence to physical activity (PA) guidelines.
Chapter 2: Research Design 25
Chapter 2: Research Design
2.1 METHODOLOGY
This is a sub-study of the EJECTION-HF trial. Methods for the full study have
been published in the European Journal of Heart Failure (Mudge et al., 2011). The
primary objective of the EJECTION study is to measure the impact of supervised
exercise training on death and readmission in heart failure patients enrolled in a post-
hospital disease management programme. While conducting this study investigators
identified difficulty sleeping as a common and debilitating complaint of study
participants. Literature review revealed a paucity of studies in heart failure patients,
but some evidence that exercise improves sleep quality in other populations. The
addition of a sleep quality questionnaire to the existing protocol would permit
exploring the potential role of exercise training on sleep quality, adding important
patient-centred data to the main study.
Both studies used a RCT design with blinded end-point analysis. Participants
were randomly assigned to a 3 month DMP of education and self-management
support including standard exercise advice (Control) or to the same DMP as the
control group with the addition of a tailored exercise programme designed and
supervised by a physiotherapist and/or clinical exercise physiologist (Intervention).
A paper based randomisation procedure was co-ordinated centrally. Randomisation
was undertaken in blocks of 10 to allow consistent referral rates to the exercise
programme and was stratified across hospital sites.
2.2 PARTICIPANTS
Study recruitment was carried out between June 2009 and August 2011.
Participants were 112 patients referred to hospital heart failure services (HFS) at
three hospitals in South East QLD, Australia including the Royal Brisbane and
Women’s Hospital, The Prince Charles Hospital and Logan Hospital. In order to be
safe to exercise and to ensure a representative HF population, participants were
26 Chapter 2: Research Design
required to meet a number of inclusion criteria. Participants were required to (1)
have been admitted to hospital with symptomatic congestive HF as a dominant
clinical diagnosis, with documented symptoms and signs of HF combined with either
chest x-ray changes or echocardiography evidence of left ventricular dysfunction
within the past 6 week period; (2) currently on medical therapy for HF1; and (3) able
to regularly attend the program and follow-ups. (Mudge, et al., 2011).
Exclusion criteria included the following: (1) a terminal diagnosis; (2) serious
cognitive impairment; (3) other serious physical impairment which would prevent
program attendance and participation; (4) Implantable Cardiac Defibrillator (ICD)
insertion within 4 weeks of programme commencement; (5) Cardiac
Resynchronisation Therapy (CRT) within 6 months of programme commencement2;
(6) awaiting cardiovascular procedure (revascularisation or hospitalisation for
surgery); (7) completed a full 12 week regime of formal exercise rehabilitation in the
past 12 month period; or (8) did not satisfy study safety criteria listed below in
Figure 1.
Figure 2. Study safety criteria.
Participants were recruited through active screening by hospital HF service
staff of emergency department, medical and cardiology ward admission lists, as well 1 Heart failure medication optimisation was not a pre-requisite for study entry therefore it is likely that certain medications may have been titrated during the study. 2 CRT is known for its positive influence on cardiac output (CO) making interpretation of the effect of exercise difficult. A decision was made to exclude patients with recent CRT to exclude this as a potential confounder of study results..
1. Refractory chest pain. 2. Uncontrolled cardiac arrhythmias causing symptoms of haemodynamic compromise. 3. High-degree AV block. 4. Pacemakers which do not permit adequate heart rate response to exercise. 5. Heart failure secondary to significant uncorrected primary valvular disease (except for mitral regurgitation secondary to LV dysfunction). 6. Isolated pulmonary hypertension. 7. Poorly controlled symptomatic postural hypotension. 8. Obstructive cardiomyopathy.
Chapter 2: Research Design 27
as by physician and ward nursing referral. The program physiotherapist or exercise
physiologist assessed all potential participants for eligibility to exercise according to
the established study safety criteria (Figure 2. Study safety criteria). The study
project officer was subsequently notified regarding eligible patients who were then
invited to participate in the research study. A written informed consent was obtained
from each patient prior to the patient’s entrance into the study. Before recruitment
and enrolment, each prospective participant was given a full explanation of the study
in plain English and was allowed to read the approved informed consent form at their
own discretion. Project staff informed the prospective participant of the purpose of
the study, randomisation of study groups and the follow-up schedule. They
discussed any foreseeable risks involved, as well as potential benefits that may result
from the new treatment, and informed the participant that their medical records will
be subject to review. The prospective participant was informed that they were free to
refuse participation in the study and, if they chose to participate, that they may
withdraw from the study at any time without compromising further medical care.
Once project staff were assured that the individual understood the implications
of participating in the study, the participant was asked to give consent to participate
in the study by signing the informed consent form. A copy of the signed consent was
provided to the patient and the original form was maintained with the participants’
records at the site (Appendix A Patient Information and Consent Form).
The study was approved by human research ethics committees (HREC) at
participating institutions and all patients gave written informed consent prior to
participation.
2.3 INSTRUMENTS
Questionnaires were administered at Baseline and 3 months post
commencement of intervention (Appendix B Pittsburgh Sleep Quality Index,
Appendix C Geriatric Depression Scale, Appendix D Six Minute Walk Test Case
Report Form, and Appendix E Study Case Report Forms).
28 Chapter 2: Research Design
2.3.1 Measurement of Primary Outcome
Sleep Quality
Sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI)
(see Appendix B). This self-rated 19-item index takes five to ten minutes to
complete and assesses sleep quality during the previous month. The PSQI offers a
concise, clinically useful review of a number of sleep disturbances (M. T. Smith &
Wegener, 2003).
The first four questions of the PSQI examine usual bed time, time it takes to
fall asleep, wake time and amount of actual sleep per night. Questions 5, 7, 8, 9 and
10 examine how often particular issues disturb sleep. These questions are rated on a
scale between 0-3, with 0 indicating the issue affected sleep “not during the past
month” and 3 “3 or more times a week”. Question 6 asks the participant to rate their
sleep quality with 0 indicating “very good” sleep quality and 3 “very bad”.
The survey assesses several components of sleep quality including 1)
2001 #971}. In our study, like that of Webb-Peploe at al (Webb-Peploe et al.,
2000)medication optimisation was not a prerequisite of study entry and it is possible
that continuing optimisation of important heart failure medications may have been a
source of confounding. However, evidence suggests that many patients do not
achieve optimal doses of medications post discharge and the extent of this potential
bias is probably small (Fonarow et al., 2008; NHS Information Centre, 2010). In
addition the high level of medication prescription at Baseline that was identified in
both study groups may guard against this as a confounder.
4.4 DIRECTIONS FOR FUTURE RESEARCH
This research has identified other issues in need of further investigation.
It is recommended that future studies be conducted in a more representative patient
group as this study was only able to recruit 12% of patients identified due to
eligibility considerations. Large, randomised controlled trials which assess both
objective and subjective measures need to be undertaken. Such investigations need
to examine the effect of exercise interventions on the different types of sleep
disorders possible in this population and clarify the relationship between objective
and subjective measures of sleep. Assessment of the effect of exercise on sleep
using a number of different screening methods may also be useful to establish which
measure is the most reliable, practical method for examining this increasingly well-
recognised issue in HF patients.
Chapter 4: Discussion 63
More information regarding the effect of confounding factors such as exposure
to bright light, increased social interaction, adverse events and the effects of other
components of the HF disease management program would also assist in the
understanding of how exercise improves sleep.
Finally, further investigation and experimentation into the best form of
exercise intervention in terms of frequency, intensity, time and type of exercise is
strongly recommended. This is important because much debate still exists regarding
which form of exercise is beneficial and the duration and intensity which produces
the best results.
64 Chapter 4: Discussion
Chapter 5: Conclusions 65
Chapter 5: Conclusions
Heart failure is a clinical condition associated with high levels of sleep
disturbance. Sleep disturbances exacerbate HF symptoms and lead to increases in
morbidity and mortality in this disease. This study has shown that the addition of a
3 month program of aerobic and resistance exercise to the usual HF DMP produces
significantly greater rates of clinical improvement in sleep quality.
In summary, in a sample of recently hospitalised HF patients, the addition of 3
months of supervised exercise training to usual care significantly improves sleep
quality. These improvements were independent of the effects of exercise training on
BMI. Improvements were related with improvements in depression and exercise
performance highlighting the antidepressant effects of exercise training and the
modulating effect of depression on sleep quality. Additional research with more
comprehensive measurement of sleep is warranted, but exercise training appears to
significantly improve sleep quality in HF patients. We anticipate that these findings
will stimulate further study.
67 Bibliography
Bibliography
Afshar, R., Emany, A., Saremi, A., Shavandi, N., & Sanavi, S. (2011). Effects of intradialytic aerobic training on sleep quality in hemodialysis patients. Iran J Kidney Dis, 5(2), 119-123
Akashi, Y. J., Springer, J., & Anker, S. D. (2005). Cachexia in chronic heart failure: prognostic implications and novel therapeutic approaches. Curr Heart Fail Rep, 2(4), 198-203
American Association of Cardiovascular and Pulmonary Rehabilitation. (2004). Guidelines for cardiac rehabilitation and secondary prevention programs. Champaign, USA: Human Kinetics Publishers.
American College of Sports Medicine. (2005). ACSM's Guidelines for Exercise Testing and Prescription (7 ed.). Philadelphia: Lea & Febiger/Lippencott Williams & Wilkines.
American College of Sports Medicine, & American Diabetes Association. (2010). Exercise and Type 2 Diabetes: American College of Sports Medicine and the American Diabetes Association: Joint Position Statement. Medicine & Science in Sports & Exercise, 42(12), 2282-2303
Arcos-Carmona, I. M., Castro-Sanchez, A. M., Mataran-Penarrocha, G. A., Gutierrez-Rubio, A. B., Ramos-Gonzalez, E., & Moreno-Lorenzo, C. (2011). [Effects of aerobic exercise program and relaxation techniques on anxiety, quality of sleep, depression, and quality of life in patients with fibromyalgia: a randomized controlled trial]. Med Clin (Barc), 137(9), 398-401
Arzt, M., Young, T., Finn, L., Skatrud, J. B., Ryan, C. M., Newton, G. E., et al. (2006). Sleepiness and sleep in patients with both systolic heart failure and obstructive sleep apnea. Arch Intern Med, 166(16), 1716-1722
ATS statement: guidelines for the six-minute walk test. (2002). Am J Respir Crit Care Med, 166(1), 111-117
. Australia's health 2012. (2012). In A. I. o. H. a. Welfare (Ed.), Australia's health series no.13. Cat. no.AUS 156. Canberra.
Basta, M., Lin, H. M., Pejovic, S., Sarrigiannidis, A., Bixler, E., & Vgontzas, A. N. (2008). Lack of regular exercise, depression, and degree of apnea are predictors of excessive daytime sleepiness in patients with sleep apnea: sex differences. J Clin Sleep Med, 4(1), 19-25
Bibliography 68
Bordier, P. (2009). Sleep apnoea in patients with heart failure: part II: therapy. Arch Cardiovasc Dis, 102(10), 711-720
Borg, G. (1982). Ratings of perceived exertion and heart rates during short-term cycle exercise and their use in a new cycling strength test. Int J Sports Med, 3(3), 153-158
Bradley, T. D., & Floras, J. S. (2003a). Sleep apnea and heart failure: Part I: obstructive sleep apnea. Circulation, 107(12), 1671-1678
Bradley, T. D., & Floras, J. S. (2003b). Sleep apnea and heart failure: Part II: central sleep apnea. Circulation, 107(13), 1822-1826
Briffa T, M. A., Allan R, et al. . (2006). National Heart Foundation of Australia physical activity recommendations
for people with cardiovascular disease. . In O. b. o. t. E. W. G. and & N. F. Participants (Eds.), National Heart Foundation of Australia. Sydney (Australia).
Brostrom, A., & Johansson, P. (2005). Sleep disturbances in patients with chronic heart failure and their holistic consequences-what different care actions can be implemented? Eur J Cardiovasc Nurs, 4(3), 183-197
Brostrom, A., Stromberg, A., Dahlstrom, U., & Fridlund, B. (2003). Congestive heart failure, spouses' support and the couple's sleep situation: a critical incident technique analysis. J Clin Nurs, 12(2), 223-233, 234
Brostrom, A., Stromberg, A., Dahlstrom, U., & Fridlund, B. (2004). Sleep difficulties, daytime sleepiness, and health-related quality of life in patients with chronic heart failure. J Cardiovasc Nurs, 19(4), 234-242
Bucca, C. B., Brussino, L., Battisti, A., Mutani, R., Rolla, G., Mangiardi, L., et al. (2007). Diuretics in obstructive sleep apnea with diastolic heart failure. Chest, 132(2), 440-446
Buysse, D. J., Reynolds, C. F., 3rd, Monk, T. H., Berman, S. R., & Kupfer, D. J. (1989). The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res, 28(2), 193-213
Caldwell, K., Harrison, M., Adams, M., & Triplett, N. T. (2009). Effect of Pilates and taiji quan training on self-efficacy, sleep quality, mood, and physical performance of college students. J Bodyw Mov Ther, 13(2), 155-163
Campbell, S. S., Dawson, D., & Anderson, M. W. (1993). Alleviation of sleep maintenance insomnia with timed exposure to bright light. J Am Geriatr Soc, 41(8), 829-836
69 Bibliography
Caples, S. M., & Somers, V. K. (2007). CPAP treatment for obstructive sleep apnoea in heart failure: expectations unmet. Eur Heart J, 28(10), 1184-1186
The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. (1999). Lancet, 353(9146), 9-13
Chan, J., Sanderson, J., Chan, W., Lai, C., Choy, D., Ho, A., et al. (1997). Prevalence of sleep-disordered breathing in diastolic heart failure. Chest, 111(6), 1488-1493
Chen, K. M., Chen, M. H., Chao, H. C., Hung, H. M., Lin, H. S., & Li, C. H. (2009). Sleep quality, depression state, and health status of older adults after silver yoga exercises: cluster randomized trial. Int J Nurs Stud, 46(2), 154-163
Chen, K. M., Chen, M. H., Lin, M. H., Fan, J. T., Lin, H. S., & Li, C. H. (2010). Effects of yoga on sleep quality and depression in elders in assisted living facilities. J Nurs Res, 18(1), 53-61
Chen, M. C., Liu, H. E., Huang, H. Y., & Chiou, A. F. (2012). The effect of a simple traditional exercise programme (Baduanjin exercise) on sleep quality of older adults: a randomized controlled trial. Int J Nurs Stud, 49(3), 265-273
Coleman, E. A., Coon, S., Hall-Barrow, J., Richards, K., Gaylor, D., & Stewart, B. (2003). Feasibility of exercise during treatment for multiple myeloma. Cancer Nurs, 26(5), 410-419
Collop, N. (2010). Sleep and sleep disorders in chronic obstructive pulmonary disease. Respiration, 80(1), 78-86
D'Ambrosio, C., Bowman, T., & Mohsenin, V. (1999). Quality of life in patients with obstructive sleep apnea: effect of nasal continuous positive airway pressure--a prospective study. Chest, 115(1), 123-129
Davie, A. P., Francis, C. M., Caruana, L., Sutherland, G. R., & McMurray, J. J. (1997). Assessing diagnosis in heart failure: which features are any use? QJM, 90(5), 335-339
de Castro Toledo Guimaraes, L. H., de Carvalho, L. B., Yanaguibashi, G., & do Prado, G. F. (2008). Physically active elderly women sleep more and better than sedentary women. Sleep Med, 9(5), 488-493
Department of Health and Ageing. (1999). National Physical Activity Guidelines for Australians. Canberra.
Driver, H. S., & Taylor, S. R. (2000). Exercise and sleep. Sleep Med Rev, 4(4), 387-402
Bibliography 70
Duarte Freitas, P., Haida, A., Bousquet, M., Richard, L., Mauriege, P., & Guiraud, T. (2011). Short-term impact of a 4-week intensive cardiac rehabilitation program on quality of life and anxiety-depression. Ann Phys Rehabil Med, 54(3), 132-143
Duarte Freitas, P., Haida, A., Bousquet, M., Richard., L., Mauriege, P., & Guirad, T. (2011). Short-term impact of a 4-week intensive cardiac rehabilitattion program on quality of life and anxiety-depression. Annals of Physical and Rehabilitation Medicine, 54, 132-143
Earley, C. J., Allen, R. P., & Hening, W. (2011). Restless legs syndrome and periodic leg movements in sleep. Handb Clin Neurol, 99, 913-948
Eddy, M., & Walbroehl, G. S. (1999). Insomnia. Am Fam Physician, 59(7), 1911-1916, 1918
Edell-Gustafsson, U. M., Gustavsson, G., & Yngman Uhlin, P. (2003). Effects of sleep loss in men and women with insufficient sleep suffering from chronic disease: a model for supportive nursing care. Int J Nurs Pract, 9(1), 49-59
Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). (1999). Lancet, 353(9169), 2001-2007
Erickson, V. S., Westlake, C. A., Dracup, K. A., Woo, M. A., & Hage, A. (2003). Sleep disturbance symptoms in patients with heart failure. AACN Clin Issues, 14(4), 477-487
Eschenhagen, T., Force, T., Ewer, M. S., de Keulenaer, G. W., Suter, T. M., Anker, S. D., et al. (2011). Cardiovascular side effects of cancer therapies: a position statement from the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail, 13(1), 1-10
Ferrier, K., Campbell, A., Yee, B., Richards, M., O'Meeghan, T., Weatherall, M., et al. (2005). Sleep-disordered breathing occurs frequently in stable outpatients with congestive heart failure. Chest, 128(4), 2116-2122
Floras, J. S. (2009). Sympathetic nervous system activation in human heart failure: clinical implications of an updated model. J Am Coll Cardiol, 54(5), 375-385
Flynn, K. E., Pina, I. L., Whellan, D. J., Lin, L., Blumenthal, J. A., Ellis, S. J., et al. (2009). Effects of exercise training on health status in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA, 301(14), 1451-1459
Fonarow, G. C., Abraham, W. T., Albert, N. M., Stough, W. G., Gheorghiade, M., Greenberg, B. H., et al. (2008). Dosing of beta-blocker therapy before,
71 Bibliography
during, and after hospitalization for heart failure (from Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure). Am J Cardiol, 102(11), 1524-1529
Fonseca, C. (2006). Diagnosis of heart failure in primary care. Heart Fail Rev, 11(2), 95-107
Gary, R., & Lee, S. Y. (2007). Physical function and quality of life in older women with diastolic heart failure: effects of a progressive walking program on sleep patterns. Prog Cardiovasc Nurs, 22(2), 72-80
Gerber, M., Brand, S., Holsboer-Trachsler, E., & Puhse, U. (2010). Fitness and exercise as correlates of sleep complaints: is it all in our minds? Med Sci Sports Exerc, 42(5), 893-901
Gill, A., Womack, R., & Safranek, S. (2010). Clinical Inquiries: Does exercise alleviate symptoms of depression? J Fam Pract, 59(9), 530-531
Gnanasekaran, G. (2011). Epidemiology of depression in heart failure. Heart Fail Clin, 7(1), 1-10
Goldberg, M. S., Giannetti, N., Burnett, R. T., Mayo, N. E., Valois, M. F., & Brophy, J. M. (2009). Shortness of breath at night and health status in congestive heart failure: effects of environmental conditions and health-related and dietary factors. Environ Res, 109(2), 166-174
Gonseth, J., Guallar-Castillon, P., Banegas, J. R., & Rodriguez-Artalejo, F. (2004). The effectiveness of disease management programmes in reducing hospital re-admission in older patients with heart failure: a systematic review and meta-analysis of published reports. Eur Heart J, 25(18), 1570-1595
Guilleminault, C., Clerk, A., Black, J., Labanowski, M., Pelayo, R., & Claman, D. (1995). Nondrug treatment trials in psychophysiologic insomnia. Arch Intern Med, 155(8), 838-844
Guilleminault, C., Stoohs, R., Clerk, A., Cetel, M., & Maistros, P. (1993). A cause of excessive daytime sleepiness. The upper airway resistance syndrome. Chest, 104(3), 781-787
Hanly, P. J., & Zuberi-Khokhar, N. (1996). Periodic limb movements during sleep in patients with congestive heart failure. Chest, 109(6), 1497-1502
Hare, D. L., & Davis, C. R. (1996). Cardiac Depression Scale: validation of a new depression scale for cardiac patients. Journal of Psychosomatic Research, 40(4), 379-386
Bibliography 72
Hare, J. M., Mangal, B., Brown, J., Fisher, C., Jr., Freudenberger, R., Colucci, W. S., et al. (2008). Impact of oxypurinol in patients with symptomatic heart failure. Results of the OPT-CHF study. J Am Coll Cardiol, 51(24), 2301-2309
Hayes, D., Jr., Anstead, M. I., Ho, J., & Phillips, B. A. (2009). Insomnia and chronic heart failure. Heart Fail Rev, 14(3), 171-182
Hayes, S. C., Spence, R. R., Galvao, D. A., & Newton, R. U. (2009). Australian Association for Exercise and Sport Science position stand: Optimising cancer outcoems through exercise. Journal of Science and Medicine in Sport, 12, 428-434
Hoch, C. C., Reynolds, C. F., 3rd, Buysse, D. J., Monk, T. H., Nowell, P., Begley, A. E., et al. (2001). Protecting sleep quality in later life: a pilot study of bed restriction and sleep hygiene. J Gerontol B Psychol Sci Soc Sci, 56(1), P52-59
Horne, J. A., & Moore, V. J. (1985). Sleep EEG effects of exercise with and without additional body cooling. Electroencephalogr Clin Neurophysiol, 60(1), 33-38
Horne, J. A., & Staff, L. H. (1983). Exercise and sleep: body-heating effects. Sleep, 6(1), 36-46
Javaheri, S. (2006). CPAP should not be used for central sleep apnea in congestive heart failure patients. J Clin Sleep Med, 2(4), 399-402
Javaheri, S., Ahmed, M., Parker, T. J., & Brown, C. R. (1999). Effects of nasal O2 on sleep-related disordered breathing in ambulatory patients with stable heart failure. Sleep, 22(8), 1101-1106
Javaheri, S., Parker, T. J., Liming, J. D., Corbett, W. S., Nishiyama, H., Wexler, L., et al. (1998). Sleep apnea in 81 ambulatory male patients with stable heart failure. Types and their prevalences, consequences, and presentations. Circulation, 97(21), 2154-2159
Johansson, P., Arestedt, K., Alehagen, U., Svanborg, E., Dahlstrom, U., & Brostrom, A. (2010). Sleep disordered breathing, insomnia, and health related quality of life -- a comparison between age and gender matched elderly with heart failure or without cardiovascular disease. Eur J Cardiovasc Nurs, 9(2), 108-117
Karvonen, M. J., Kentala, E., & Mustala, O. (1957). The effects of training on heart rate; a longitudinal study. Ann Med Exp Biol Fenn, 35(3), 307-315
73 Bibliography
Kasai, T., & Bradley, T. D. (2011). Obstructive sleep apnea and heart failure: pathophysiologic and therapeutic implications. J Am Coll Cardiol, 57(2), 119-127
Keteyian, S. J., Leifer, E. S., Houston-Miller, N., Kraus, W. E., Brawner, C. A., O'Connor, C. M., et al. (2012). Relation between volume of exercise and clinical outcomes in patients with heart failure. J Am Coll Cardiol, 60(19), 1899-1905
Khayat, R. N., Abraham, W. T., Patt, B., Roy, M., Hua, K., & Jarjoura, D. (2008). Cardiac effects of continuous and bilevel positive airway pressure for patients with heart failure and obstructive sleep apnea: a pilot study. Chest, 134(6), 1162-1168
King, A. C., Oman, R. F., Brassington, G. S., Bliwise, D. L., & Haskell, W. L. (1997). Moderate-intensity exercise and self-rated quality of sleep in older adults. A randomized controlled trial. JAMA, 277(1), 32-37
King, A. C., Pruitt, L. A., Woo, S., Castro, C. M., Ahn, D. K., Vitiello, M. V., et al. (2008). Effects of moderate-intensity exercise on polysomnographic and subjective sleep quality in older adults with mild to moderate sleep complaints. J Gerontol A Biol Sci Med Sci, 63(9), 997-1004
Kline, C. E., Crowley, E. P., Ewing, G. B., Burch, J. B., Blair, S. N., Durstine, J. L., et al. (2011). The effect of exercise training on obstructive sleep apnea and sleep quality: a randomized controlled trial. Sleep, 34(12), 1631-1640
Kline, C. E., Sui, X., Hall, M. H., Youngstedt, S. D., Blair, S. N., Earnest, C. P., et al. (2012). Dose-response effects of exercise training on the subjective sleep quality of postmenopausal women: exploratory analyses of a randomised controlled trial. BMJ Open, 2(4)
Krachman, S. L., D'Alonzo, G. E., Permut, I., & Chatila, W. (2009). Treatment of sleep disordered breathing in congestive heart failure. Heart Fail Rev, 14(3), 195-203
Lande, R. G., & Gragnani, C. (2010). Nonpharmacologic approaches to the management of insomnia. J Am Osteopath Assoc, 110(12), 695-701
Lavie, C. J., & Milani, R. V. (2001). Benefits of cardiac rehabilitation and exercise training programs in elderly coronary patients. Am J Geriatr Cardiol, 10(6), 323-327
Lewith, G. T., Godfrey, A. D., & Prescott, P. (2005). A single-blinded, randomized pilot study evaluating the aroma of Lavandula augustifolia as a treatment for mild insomnia. J Altern Complement Med, 11(4), 631-637
Bibliography 74
Li, F., Fisher, K. J., Harmer, P., Irbe, D., Tearse, R. G., & Weimer, C. (2004). Tai chi and self-rated quality of sleep and daytime sleepiness in older adults: a randomized controlled trial. J Am Geriatr Soc, 52(6), 892-900
MacDonald, M. R., Eurich, D. T., Majumdar, S. R., Lewsey, J. D., Bhagra, S., Jhund, P. S., et al. (2010). Treatment of type 2 diabetes and outcomes in patients with heart failure: a nested case-control study from the U.K. General Practice Research Database. Diabetes Care, 33(6), 1213-1218
Macey, P. M., Woo, M. A., Kumar, R., Cross, R. L., & Harper, R. M. (2010). Relationship between obstructive sleep apnea severity and sleep, depression and anxiety symptoms in newly-diagnosed patients. PLoS One, 5(4), e10211
Manocchia, M., Keller, S., & Ware, J. E. (2001). Sleep problems, health-related quality of life, work functioning and health care utilization among the chronically ill. Qual Life Res, 10(4), 331-345
Mant, J., Doust, J., Roalfe, A., Barton, P., Cowie, M. R., Glasziou, P., et al. (2009). Systematic review and individual patient data meta-analysis of diagnosis of heart failure, with modelling of implications of different diagnostic strategies in primary care. Health Technol Assess, 13(32), 1-207, iii
Mared, L., Cline, C., Erhardt, L., Berg, S., & Midgren, B. (2004). Cheyne-Stokes respiration in patients hospitalised for heart failure. Respir Res, 5, 14
McAlister, F. A., Stewart, S., Ferrua, S., & McMurray, J. J. (2004). Multidisciplinary strategies for the management of heart failure patients at high risk for admission: a systematic review of randomized trials. J Am Coll Cardiol, 44(4), 810-819
McMurray, J. J., & Pfeffer, M. A. (2005). Heart failure. Lancet, 365(9474), 1877-1889
Montemurro, L. T., Floras, J. S., Millar, P. J., Kasai, T., Gabriel, J. M., Spaak, J., et al. (2012). Inverse Relationship of Subjective Daytime Sleepiness to Sympathetic Activity in Heart Failure Patients with Obstructive Sleep Apnea. Chest
Morgan, K., Dixon, S., Mathers, N., Thompson, J., & Tomeny, M. (2003). Psychological treatment for insomnia in the management of long-term hypnotic drug use: a pragmatic randomised controlled trial. Br J Gen Pract, 53(497), 923-928
Mosterd, A., & Hoes, A. W. (2007). Clinical epidemiology of heart failure. Heart, 93(9), 1137-1146
75 Bibliography
Mudge, A. M., Denaro, C. P., Scott, A. C., Atherton, J. J., Meyers, D. E., Marwick, T. H., et al. (2011). Exercise training in recently hospitalized heart failure patients enrolled in a disease management programme: design of the EJECTION-HF randomized controlled trial. Eur J Heart Fail, 13(12), 1370-1375
Muller, J., Christov, F., Schreiber, C., Hess, J., & Hager, A. (2009). Exercise capacity, quality of life, and daily activity in the long-term follow-up of patients with univentricular heart and total cavopulmonary connection. Eur Heart J, 30(23), 2915-2920
Myllymaki, T., Rusko, H., Syvaoja, H., Juuti, T., Kinnunen, M. L., & Kyrolainen, H. (2012). Effects of exercise intensity and duration on nocturnal heart rate variability and sleep quality. Eur J Appl Physiol, 112(3), 801-809
Narkiewicz, K., Pesek, C. A., Kato, M., Phillips, B. G., Davison, D. E., & Somers, V. K. (1998). Baroreflex control of sympathetic nerve activity and heart rate in obstructive sleep apnea. Hypertension, 32(6), 1039-1043
National Health Service Information Centre. (2010). National Heart Failure Audit. Leeds.
National Heart Foundation of Australia and the Cardiac Society of Australia and New Zealand. (Updated October 2011.). Guidelines for the prevention, detection and management of chronic heart failure in Australia. In C. H. F. G. E. W. Panel. (Ed.).
National Heart Foundation of Australia and the Cardiac Society of Australia and New Zealand. (2006). Guidelines for the prevention, detection and management of chronic heart failure in Australia.
National Heart Foundation of Australian and the Cardiac Society of Australia and New Zealand. (2006). Guidelines for the Prevention, Detection and Management of Chronic Heart Failure in Australia. In C. H. F. G. E. W. Panel (Ed.).
Naughton, M. T., Benard, D. C., Liu, P. P., Rutherford, R., Rankin, F., & Bradley, T. D. (1995). Effects of nasal CPAP on sympathetic activity in patients with heart failure and central sleep apnea. Am J Respir Crit Care Med, 152(2), 473-479
NHS Information Centre. (2010). National Heart Failure Audit 2010. Leeds.
Niebauer, J., Clark, A. L., Webb-Peploe, K. M., & Coats, A. J. (2005). Exercise training in chronic heart failure: effects on pro-inflammatory markers. Eur J Heart Fail, 7(2), 189-193
Bibliography 76
Norman, J. F., Von Essen, S. G., Fuchs, R. H., & McElligott, M. (2000). Exercise training effect on obstructive sleep apnea syndrome. Sleep Res Online, 3(3), 121-129
O'Connor, C. M., Jiang, W., Kuchibhatla, M., Silva, S. G., Cuffe, M. S., Callwood, D. D., et al. (2010). Safety and efficacy of sertraline for depression in patients with heart failure: results of the SADHART-CHF (Sertraline Against Depression and Heart Disease in Chronic Heart Failure) trial. J Am Coll Cardiol, 56(9), 692-699
O'Connor, C. M., Whellan, D. J., Lee, K. L., Keteyian, S. J., Cooper, L. S., Ellis, S. J., et al. (2009). Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA, 301(14), 1439-1450
Opasich, C., Pinna, G. D., Mazza, A., Febo, O., Riccardi, R., Riccardi, P. G., et al. (2001). Six-minute walking performance in patients with moderate-to-severe heart failure; is it a useful indicator in clinical practice? Eur Heart J, 22(6), 488-496
Oudejans, I., Mosterd, A., Bloemen, J. A., Valk, M. J., van Velzen, E., Wielders, J. P., et al. (2011). Clinical evaluation of geriatric outpatients with suspected heart failure: value of symptoms, signs, and additional tests. Eur J Heart Fail, 13(5), 518-527
Packer, M., Bristow, M. R., Cohn, J. N., Colucci, W. S., Fowler, M. B., Gilbert, E. M., et al. (1996). The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med, 334(21), 1349-1355
Packer, M., Coats, A. J., Fowler, M. B., Katus, H. A., Krum, H., Mohacsi, P., et al. (2001). Effect of carvedilol on survival in severe chronic heart failure. N Engl J Med, 344(22), 1651-1658
Paparrigopoulos, T., Tzavara, C., Theleritis, C., Soldatos, C., & Tountas, Y. (2010). Physical activity may promote sleep in cardiac patients suffering from insomnia. Int J Cardiol, 143(2), 209-211
Parish, J. M. (2009). Sleep-related problems in common medical conditions. Chest, 135, 563-572
Parker, K. P., & Dunbar, S. B. (2002). Sleep and heart failure. J Cardiovasc Nurs, 17(1), 30-41
Passos, G. S., Poyares, D., Santana, M. G., D'Aurea, C. V., Youngstedt, S. D., Tufik, S., et al. (2011). Effects of moderate aerobic exercise training on chronic primary insomnia. Sleep Med, 12(10), 1018-1027
77 Bibliography
Payne, J. K., Held, J., Thorpe, J., & Shaw, H. (2008). Effect of exercise on biomarkers, fatigue, sleep disturbances, and depressive symptoms in older women with breast cancer receiving hormonal therapy. Oncol Nurs Forum, 35(4), 635-642
Pedersen, B. K. (2006). The anti-inflammatory effect of exercise: its role in diabetes and cardiovascular disease control. Essays Biochem, 42, 105-117
Phillips, C., Wright, S., Kern, D., Singa, R., Shepperd, & Rubin, H. (2004). Comprehensive discharge planning with postdischarge support for older patients with congestive heart failure: a meta-analysis. JAMA, 291(11), 1358-1367
Phillips, E. M., Schneider, J. C., & Mercer, G. R. (2004). Motivating elders to initiate and maintain exercise. Arch Phys Med Rehabil, 85(Supp 3), S52-S57
Piepoli, M. F., Davos, C., Francis, D. P., & Coats, A. J. (2004). Exercise training meta-analysis of trials in patients with chronic heart failure (ExTraMATCH). BMJ, 328(7433), 189
Ponikowski, P. P., Chua, T. P., Francis, D. P., Capucci, A., Coats, A. J., & Piepoli, M. F. (2001). Muscle ergoreceptor overactivity reflects deterioration in clinical status and cardiorespiratory reflex control in chronic heart failure. Circulation, 104(19), 2324-2330
Quan, S. F., O'Connor, C. M., Quan, J. S., Redline, S., Resnick, H. E., Shahar, E., et al. (2007). Association of physical activity with sleep-disordered breathing. Sleep & Breathing, 11(3), 149-157
Randerath, W. J., Galetke, W., Kenter, M., Richter, K., & Schafer, T. (2009). Combined adaptive servo-ventilation and automatic positive airway pressure (anticyclic modulated ventilation) in co-existing obstructive and central sleep apnea syndrome and periodic breathing. Sleep Med, 10(8), 898-903
Rao, A., & Gray, D. (2005). Impact of heart failure on quality of sleep. Postgrad Med J, 81(952), 99-102
Redeker, N. S. (2008). Sleep disturbance in people with heart failure: implications for self-care. J Cardiovasc Nurs, 23(3), 231-238
Redeker, N. S., Jeon, S., Muench, U., Campbell, D., Walsleben, J., & Rapoport, D. M. (2010). Insomnia symptoms and daytime function in stable heart failure. Sleep, 33(9), 1210-1216
Reeder, C. E., Franklin, M., & Bramley, T. J. (2007). Current landscape of insomnia in managed care. Am J Manag Care, 13(5 Suppl), S112-116
Bibliography 78
Reid, K. J., Baron, K. G., Lu, B., Naylor, E., Wolfe, L., & Zee, P. C. (2010). Aerobic exercise improves self-reported sleep and quality of life in older adults with insomnia. Sleep Med, 11(9), 934-940
Reilly, T. (1990). Human circadian rhythms and exercise. Crit Rev Biomed Eng, 18(3), 165-180
Richards, K. C., Lambert, C., Beck, C. K., Bliwise, D. L., Evans, W. J., Kalra, G. K., et al. (2011). Strength training, walking, and social activity improve sleep in nursing home and assisted living residents: randomized controlled trial. J Am Geriatr Soc, 59(2), 214-223
Roccaforte, R., Demers, C., Baldassarre, F., Teo, K. K., & Yusuf, S. (2005). Effectiveness of comprehensive disease management programmes in improving clinical outcomes in heart failure patients. A meta-analysis. Eur J Heart Fail, 7(7), 1133-1144
Rosenwinkel, E. T., Bloomfield, D. M., Arwady, M. A., & Goldsmith, R. L. (2001). Exercise and autonomic function in health and cardiovascular disease. Cardiol Clin, 19(3), 369-387
Sabbagh, R., Iqbal, S., Vasilevsky, M., & Barre, P. (2008). Correlation between physical functioning and sleep disturbances in hemodialysis patients. Hemodial Int, 12 Suppl 2, S20-24
Sakkas, G. K., Hadjigeorgiou, G. M., Karatzaferi, C., Maridaki, M. D., Giannaki, C. D., Mertens, P. R., et al. (2008). Intradialytic aerobic exercise training ameliorates symptoms of restless legs syndrome and improves functional capacity in patients on hemodialysis: a pilot study. ASAIO J, 54(2), 185-190
Saleh, D. K., Nouhi, S., Zandi, H., Lankarani, M. M., Assari, S., & Pishgou, B. (2008). The quality of sleep in coronary artery disease patients with and without anxiety and depressive symptoms. Indian Heart J, 60(4), 309-312
Schaffernocker, T., Ho, J., & Hayes, D., Jr. (2009). Sleep-associated movement disorders and heart failure. Heart Fail Rev, 14(3), 165-170
Schultz, H. D., Li, Y. L., & Ding, Y. (2007). Arterial chemoreceptors and sympathetic nerve activity: implications for hypertension and heart failure. Hypertension, 50(1), 6-13
Selig, S. E., Levinger, I., Willimas, A. D., Smart, N., Holland, D. J., Maiorana, A., et al. (2010). Exercise and Sports Science Australia Position Statmen on exercise training and chronic heart failure. Journal of Science and Medicine in Sport, 13, 288-294
79 Bibliography
Sengul, Y. S., Ozalevli, S., Oztura, I., Itil, O., & Baklan, B. (2011). The effect of exercise on obstructive sleep apnea: a randomized and controlled trial. Sleep Breath, 15(1), 49-56
Servantes, D. M., Pelcerman, A., Salvetti, X. M., Salles, A. F., de Albuquerque, P. F., de Salles, F. C., et al. (2012). Effects of home-based exercise training for patients with chronic heart failure and sleep apnoea: a randomized comparison of two different programmes. Clin Rehabil, 26(1), 45-57
Sherrill, D. L., Kotchou, K., & Quan, S. F. (1998). Association of physical activity and human sleep disorders. Arch Intern Med, 158(17), 1894-1898
Shiotani, H., Umegaki, Y., Tanaka, M., Kimura, M., & Ando, H. (2009). Effects of aerobic exercise on the circadian rhythm of heart rate and blood pressure. Chronobiol Int, 26(8), 1636-1646
Silber, M. H., Ehrenberg, B. L., Allen, R. P., Buchfuhrer, M. J., Earley, C. J., Hening, W. A., et al. (2004). An algorithm for the management of restless legs syndrome. Mayo Clin Proc, 79(7), 916-922
Sin, D. D., Fitzgerald, F., Parker, J. D., Newton, G., Floras, J. S., & Bradley, T. D. (1999). Risk factors for central and obstructive sleep apnea in 450 men and women with congestive heart failure. Am J Respir Crit Care Med, 160(4), 1101-1106
Sin, D. D., & Man, G. C. (2003). Cheyne-Stokes respiration: a consequence of a broken heart? Chest, 124(5), 1627-1628
Singh, N. A., Clements, K. M., & Fiatarone, M. A. (1997). A randomized controlled trial of the effect of exercise on sleep. Sleep, 20(2), 95-101
Sinha, A. M., Skobel, E. C., Breithardt, O. A., Norra, C., Markus, K. U., Breuer, C., et al. (2004). Cardiac resynchronization therapy improves central sleep apnea and Cheyne-Stokes respiration in patients with chronic heart failure. J Am Coll Cardiol, 44(1), 68-71
Smith, M. T., & Wegener, S. T. (2003). Measures of Sleep. Arthritis & Rheumatism, 49(5S), S185-S196
Smith, S. S., Doyle, G., Pascoe, T., Douglas, J. A., & Jorgensen, G. (2007). Intention to exercise in patients with obstructive sleep apnea. J Clin Sleep Med, 3(7), 689-694
Smyth, C. (2007). The Pittsburgh Sleep Quality Index (PSQI). Best Practices in Nursing Care to Older Adults(6.1)
Bibliography 80
Solin, P., Kaye, D. M., Little, P. J., Bergin, P., Richardson, M., & Naughton, M. T. (2003). Impact of sleep apnea on sympathetic nervous system activity in heart failure. Chest, 123(4), 1119-1126
Spaak, J., Egri, Z. J., Kubo, T., Yu, E., Ando, S., Kaneko, Y., et al. (2005). Muscle sympathetic nerve activity during wakefulness in heart failure patients with and without sleep apnea. Hypertension, 46(6), 1327-1332
Spieker, E. D., & Motzer, S. A. (2003). Sleep-disordered breathing in patients with heart failure: pathophysiology, assessment, and management. J Am Acad Nurse Pract, 15(11), 487-493
Sprod, L. K., Palesh, O. G., Janelsins, M. C., Peppone, L. J., Heckler, C. E., Adams, M. J., et al. (2010). Exercise, sleep quality, and mediators of sleep in breast and prostate cancer patients receiving radiation therapy. Community Oncol, 7(10), 463-471
Steiner, S., Schueller, P. O., Schannwell, C. M., Hennersdorf, M., & Strauer, B. E. (2007). Effects of continuous positive airway pressure on exercise capacity in chronic heart failure patients without sleep apnea. J Physiol Pharmacol, 58 Suppl 5(Pt 2), 665-672
Stewart, S., MacIntyre, K., Hole, D. J., Capewell, S., & McMurray, J. J. (2001). More 'malignant' than cancer? Five-year survival following a first admission for heart failure. Eur J Heart Fail, 3(3), 315-322
Tang, M. F., Liou, T. H., & Lin, C. C. (2010). Improving sleep quality for cancer patients: benefits of a home-based exercise intervention. Support Care Cancer, 18(10), 1329-1339
Tarsey, D., & Sheon, R. (2012). Restless legs syndrome. In H. Hurtig, M. Patterson, M. Sanders & R. Benca (Eds.).
Taylor, S., Bestall, J., Cotter, S., Falshaw, M., Hood, S., Parsons, S., et al. (2005). Clinical service organisation for heart failure. Cochrane Database Syst Rev(2), CD002752
Trupp, R. J. (2004). The heart of sleep: sleep-disordered breathing and heart failure. J Cardiovasc Nurs, 19(6 Suppl), S67-74
Trupp, R. J., Hardesty, P., Osborne, J., Shelby, S., Lamba, S., Ali, V., et al. (2004). Prevalence of sleep disordered breathing in a heart failure program. Congest Heart Fail, 10(5), 217-220
Tworoger, S. S., Yasui, Y., Vitiello, M. V., Schwartz, R. S., Ulrich, C. M., Aiello, E. J., et al. (2003). Effects of a yearlong moderate-intensity exercise and a
81 Bibliography
stretching intervention on sleep quality in postmenopausal women. Sleep, 26(7), 830-836
Uchida, S., Shioda, K., Morita, Y., Kubota, C., Ganeko, M., & Takeda, N. (2012). Exercise effects on sleep physiology. Front Neurol, 3, 48
Ueno, L. M., Drager, L. F., Rodrigues, A. C., Rondon, M. U., Braga, A. M., Mathias, W., Jr., et al. (2009). Effects of exercise training in patients with chronic heart failure and sleep apnea. Sleep, 32(5), 637-647
van der Meer, S., Zwerink, M., van Brussel, M., van der Valk, P., Wajon, E., & van der Palen, J. (2012). Effect of outpatient exercise training programmes in patients with chronic heart failure: a systematic review. Eur J Prev Cardiol, 19(4), 795-803
Van Someren, E. J., Lijzenga, C., Mirmiran, M., & Swaab, D. F. (1997). Long-term fitness training improves the circadian rest-activity rhythm in healthy elderly males. J Biol Rhythms, 12(2), 146-156
Vitiello, M. V., Larsen, L. H., & Moe, K. E. (2004). Age-related sleep change: Gender and estrogen effects on the subjective-objective sleep quality relationships of healthy, noncomplaining older men and women. J Psychosom Res, 56(5), 503-510
Vuori, I., Urponen, H., Hasan, J., & Partinen, M. (1988). Epidemiology of exercise effects on sleep. Acta Physiol Scand Suppl, 574, 3-7
Walters, A. S., & Rye, D. B. (2009). Review of the relationship of restless legs syndrome and periodic limb movements in sleep to hypertension, heart disease, and stroke. Sleep, 32(5), 589-597
Wang, H. Q., Chen, G., Li, J., Hao, S. M., Gu, X. S., Pang, J. N., et al. (2009). Subjective sleepiness in heart failure patients with sleep-related breathing disorder. Chin Med J (Engl), 122(12), 1375-1379
Wang, H. Q., Chen, G., Li, J., Hao, S. M., Pang, J. N., Gu, X. S., et al. (2009). [Changes of the characteristics of sleep apnea in heart failure patients and the associated factors]. Zhonghua Jie He He Hu Xi Za Zhi, 32(8), 598-602
Webb-Peploe, K. M., Chua, T. P., Harrington, D., Henein, M. Y., Gibson, D. G., & Coats, A. J. (2000). Different response of patients with idiopathic and ischaemic dilated cardiomyopathy to exercise training. Int J Cardiol, 74(2-3), 215-224
Wise, F. M., Harris, D. W., & Carter, L. M. (2006). Validation of the Cardiac Depression Scale in a cardiac rehabilitation population. Journal of Psychosomatic Research, 60, 177-183
Bibliography 82
Yamamoto, U., Mohri, M., Shimada, K., Origuchi, H., Miyata, K., Ito, K., et al. (2007). Six-month aerobic exercise training ameliorates central sleep apnea in patients with chronic heart failure. J Card Fail, 13(10), 825-829
Yang, P. Y., Ho, K. H., Chen, H. C., & Chien, M. Y. (2012). Exercise training improves sleep quality in middle-aged and older adults with sleep problems: a systematic review. J Physiother, 58(3), 157-163
Yeh, G. Y., Mietus, J. E., Peng, C. K., Phillips, R. S., Davis, R. B., Wayne, P. M., et al. (2008). Enhancement of sleep stability with Tai Chi exercise in chronic heart failure: preliminary findings using an ECG-based spectrogram method. Sleep Med, 9(5), 527-536
Yeh, G. Y., Wayne, P. M., & Phillips, R. S. (2008). T'ai Chi exercise in patients with chronic heart failure. Medicine & Sport Science, 52, 195-208
Young-McCaughan, S., Mays, M. Z., Arzola, S. M., Yoder, L. H., Dramiga, S. A., Leclerc, K. M., et al. (2003). Research and commentary: Change in exercise tolerance, activity and sleep patterns, and quality of life in patients with cancer participating in a structured exercise program. Oncol Nurs Forum, 30(3), 441-454; discussion 441-454
Young, T., Skatrud, J., & Peppard, P. E. (2004). Risk factors for obstructive sleep apnea in adults. JAMA, 291(16), 2013-2016
Youngstedt, S. D. (2001). Ceiling and floor effects in sleep research. Sleep Med Rev, 5(1), 79-81
Youngstedt, S. D. (2005). Effects of exercise on sleep. Clin Sports Med, 24(2), 355-365, xi
Youngstedt, S. K., C. (2006). Epidemiology of exercise and sleep. Japanese Scoiety of Sleep Research, 4, 215-221
Yu, D. S., Thompson, D. R., & Lee, D. T. (2006). Disease management programmes for older people with heart failure: crucial characteristics which improve post-discharge outcomes. Eur Heart J, 27(5), 596-612
Zugck, C., Kruger, C., Durr, S., Gerber, S. H., Haunstetter, A., Hornig, K., et al. (2000). Is the 6-minute walk test a reliable substitute for peak oxygen uptake in patients with dilated cardiomyopathy? Eur Heart J, 21(7), 540-549
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Appendices
Appendix A Patient Information and Consent Form
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Appendices 85
86 Appendices
Appendices 87
Appendix B Pittsburgh Sleep Quality Index
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Appendices 89
Appendix C Geriatric Depression Scale
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Appendix D Six Minute Walk Test Case Report Form
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92 Appendices
Appendices 93
94 Appendices
Appendix E Study Case Report Forms
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96 Appendices
Appendices 97
98 Appendices
Appendices 99
100 Appendices
Appendices 101
102 Appendices
Appendix F PSQI Administration Instructions and Scoring
Form Administration Instructions The range of values for questions 5 through 10 are all 0 to 3. Questions 1 through 9 are not allowed to be missing except as noted below. If these questions are missing then any scores calculated using missing questions are also missing. Thus it is important to make sure that all questions 1 through 9 have been answered. In the event that a range is given for an answer (for example, ‘30 to 60’ is written as the answer to Q2, minutes to fall asleep), split the difference and enter 45. Reference Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ: The Pittsburgh Sleep Quality Index: A new instrument for psychiatric practice and research. Psychiatry Research 28:193-213, 1989. Scores – reportable in publications On May 20, 2005, on the instruction of Dr. Daniel J. Buysse, the scoring of the PSQI was changed to set the score for Q5J to 0 if either the comment or the value was missing. This may reduce the DISTB score by 1 point and the PSQI Total Score by 1 point. PSQIDURAT DURATION OF SLEEP IF Q4 > 7, THEN set value to 0 IF Q4 < 7 and > 6, THEN set value to 1 IF Q4 < 6 and > 5, THEN set value to 2 IF Q4 < 5, THEN set value to 3
IF Q5b + Q5c + Q5d + Q5e + Q5f + Q5g + Q5h + Q5i + Q5j (IF Q5JCOM is null or Q5j is null, set the value of Q5j to 0) = 0, THEN set value to 0
IF Q5b + Q5c + Q5d + Q5e + Q5f + Q5g + Q5h + Q5i + Q5j (IF Q5JCOM is null or Q5j is null, set the value of Q5j to 0) > 1 and < 9, THEN set value to 1
IF Q5b + Q5c + Q5d + Q5e + Q5f + Q5g + Q5h + Q5i + Q5j (IF Q5JCOM is null or Q5j is null, set the value of Q5j to 0) > 9 and < 18, THEN set value to 2
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IF Q5b + Q5c + Q5d + Q5e + Q5f + Q5g + Q5h + Q5i + Q5j (IF Q5JCOM is null or Q5j is null, set the value of Q5j to 0) > 18, THEN set value to 3
Minimum Score = 0 (better); Maximum Score = 3 (worse)
PSQILATEN SLEEP LATENCY First, recode Q2 into Q2new thusly:
IF Q2 > 0 and < 15, THEN set value of Q2new to 0 IF Q2 > 15 and < 30, THEN set value of Q2new to 1 IF Q2 > 30 and < 60, THEN set value of Q2new to 2 IF Q2 > 60, THEN set value of Q2new to 3 Next
IF Q5a + Q2new = 0, THEN set value to 0 IF Q5a + Q2new > 1 and < 2, THEN set value to 1 IF Q5a + Q2new > 3 and < 4, THEN set value to 2 IF Q5a + Q2new > 5 and < 6, THEN set value to 3
Minimum Score = 0 (better); Maximum Score = 3 (worse)
PSQIDAYDYS DAY DYSFUNCTION DUE TO SLEEPINESS IF Q8 + Q9 = 0, THEN set value to 0 IF Q8 + Q9 > 1 and < 2, THEN set value to 1 IF Q8 + Q9 > 3 and < 4, THEN set value to 2 IF Q8 + Q9 > 5 and < 6, THEN set value to 3
Diffsec = Difference in seconds between day and time of day Q1 and day Q3
Diffhour = Absolute value of diffsec / 3600 newtib =IF diffhour > 24, then newtib = diffhour – 24
IF diffhour < 24, THEN newtib = diffhour (NOTE, THE ABOVE JUST CALCULATES THE HOURS BETWEEN GNT (Q1) AND GMT (Q3))
tmphse = (Q4 / newtib) * 100
IF tmphse > 85, THEN set value to 0 IF tmphse < 85 and > 75, THEN set value to 1 IF tmphse < 75 and > 65, THEN set value to 2 IF tmphse < 65, THEN set value to 3