Budget for Project $188.0 0 $1,607. 65 $44.98 $749.2 5

8/14/2019 Budget for Project $188.0 0 $1,607. 65 $44.98 $749.2 5

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Appendix

Institutional Review Board

Des Moines University-Osteopathic Medical Center

INSTITUTIONAL REVIEW BOARD

APPLICATION FOR CLINICAL INVESTIGATION

Click on the blank response lines and type. All response areas will automaticallyexpand.

PART A (to be completed by all applicants):

PRINCIPAL INVESTIGATOR/PROJECT DIRECTOR: James B. Burns PT.

Budget for project

Principal investigator 5 hrs$188.0

0

Student investigator 45 hrs$1,607.

65materials

paper $44.98

software$749.2

5

Total2589.8

8


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DEPARTMENT: PHYSICAL MEDICINE AND REHABILITYATION TELEPHONE: (423)-926-1171 ext. 2535.

PROJECT TITLE: Obesity and Electric Mobility

Is this a new application? Yes No

RECORD OF PREVIOUS REVIEWS (Give Institution, Date of Review, attach a copy of therecommendations to this application):

FUNDING SOURCE: Is this part of a grant application? Yes No If yes, thencomplete Part G.

INVESTIGATOR(S) CREDENTIALS (list name, academic rank, and profession; use anothersheet of paper if needed) :

James B. Burns

Bachelors of Science in Physical Therapy

Physical Therapist Acute Care

THIS PROTOCOL IS EXPECTED TO MAKE USE OF (mark the appropriate responses):

Laboratory Services (if YES, complete Part C) Yes No

Experimental Drugs (if YES, complete Part D) Yes No

New Use for an Established Drug (if YES, complete Part D) Yes No

Radioactive Agents (if YES, complete Part E) Yes No


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Surgical Tissue or Fluid, Including Blood (if YES, complete Part F) Yes No

Medical Records Yes No

Exercise Protocols Yes No

Other (i.e., psychological tests, questionnaires, personal tests, surveys, etc.) Yes No

SUBJECT POPULATION (fill in all the areas that apply):

Number: Male 62 Female 0 Minors (under age 18) 0 Age range: 43- 88

Type: Inpatients Outpatients Students Other

Institutionalized Subjects (prisoners, mentally disabled persons)Pregnant Women

Expected duration of study: 1 year Expected duration of study on individual subject: 1year

Location at which subjects will be contacted (specify location/s): NA

Location at which subjects will be seen (specify location/s): NA


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Mark the appropriate response:

If subjects are inpatients, will this study increase the hospital stay?Yes No

If subjects are outpatients, will they be seen solely for the purposes of this study or will they

be seen as part of a regularly scheduled visit? StudyRegular visit

Will subjects be charged for any research-related procedure?Yes No

Will subjects receive inducements before or rewards after the study, e.g., meals, taxi fares,cash? Yes No

EMERGENCY CARE PROCEDURES:

What provisions have been made for the care of the subject in the event of an accident orcomplication related to the research procedures (even if the possibility of any complicationis slight)?

The information gleaned will be in the process of their standard care at the James H. QuillenMedical Center. If any accident or complication occurs then the Medical Center will treatthem as needed.

Will the subject be charged for care resulting from research-related accidents orcomplications? If yes, explain.

No; it will be covered by the Veterans Administration Medical Center.


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The undersigned accepts responsibility for assuring that all applicable DHHS and IRB policiesrelative to the protection of the rights and welfare of patients/subjects used in this study areadhered to.

_________James B. Burns PT _________________________ _____11/22/09_____________

Principal InvestigatorDate

This protocol has been reviewed and approved for submission to the Institutional ReviewBoard.

___________________________________________________ _____________

Department Chairman or Head of DepartmentDate

___________________________________________________ _____________

Dean Date

The undersigned certify that this proposal has been reviewed and approved in conformancewith policies established by the DHHS and the IRB of Des Moines University-OsteopathicMedical Center for the protection of human subjects and with FDA regulations on review of IND studies.

__________________________________________________ _______________________

Chairman, Institutional Review Board Date


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__________________________________________________ _______________________

Signature of Faculty Mentor Date

__________________________________________________ _______________________

Institutional Official Date


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PART B: Outline to be Followed for Clinical Investigation Protocols

(To be completed by all applicants and attached to the application)

The following is a brief outline of the points that should be covered when submitting a researchprotocol to the IRB.

1. INTRODUCTION

Literature Review:

Genetic and Immunological aspects of obesity:

Obesity is a growing trend in many countries around the world. In the United States obesity hasincreased in the past 20 years to the point that 25% of the people in two thirds of the stateshave a body mass index (BMI) of greater than 30% 1 . The cause of obesity is often thought to berelated to an increase in the calories ingested as compared to the calories worked off thoughphysical activity. This, however, only tells part of the story. The genetic component of obesityhas been suggested in several articles. Obesity is increasing in the United States and otherdeveloped countries. This increase has occurred so quickly that it cannot be explained withpopulation genetics. This is because the effects of population genetics are too slow, 2 and therise in obesity has happened relatively quickly. However, if the gene existed from long ago andthe conditions for its expression only recently developed, this would explain the growth of girthin the population. The energy-thrifty genes 2 were genes that caused humans to storeincreased amounts of energy when it was available to be used in times when it was notavailable. This genetic ability gave the individuals with it the ability to survive and pass on theirgenes. The way the gene does this is by allowing the individual to storing more caloric energywhen food is in great abundance, and then allowing the individual to convert this stored enerywhen food is not as readily available.

This is just one theory. Others include the tendency to overeat and not be satiated, tendenciestoward sedentary life style, diminished abilities to use dietary fats as fuel, and improved abilityto store body fat 2 . One study suggested that there is a social stigma associated with increasedbody size, thereby causing an increased rate of assortative mating in obese individuals 3 . That isto say the obese people mate selectively with other obese people. This would cause these obeseindividuals to have obese children. This particular study does not take out enough of theenvironmental factors to be very conclusive. However, it does give rise to another theory of theprevalence of obesity. In a study that looked at Scottish children a gene variant of the FTO wasfound. This variant has been indicated in obesity and may have a role in food intake and energyconsumption 4 . One of the key findings of the FTO gene is that it appears to be a very common


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variant. At least one copy of the FTO gene appears to be present in over half of the population.About one sixth of the population has two copies of the FTO gene 5 .

The immune system has also been indicated as a possible cause for genetic changes takingplace that increased the prevalence of obesity. Roth in his study suggests that individuals withincreased visceral fat deposits secrete more proinflammatory elements such as tumor necrosisfactor (TNF). The author suggests that although this may not help with the primary infection of tuberculosis (TB), the individual that had the visceral fat would have an advantage in that TBmoves out of the lungs and into the body where it can stay dormant for years waiting for a timeto come forth again. The individuals with the proinflammatory factors had an advantage againstthe TB virus and according to the author had decreased relapses. The author suggests thatbefore effective drug therapy for tuberculosis, these products could have provided anadvantage for the infected host 6. This would give the individual an evolutionary advantage topass on these genes.

Cost of Obesity:

According to the Centers for Disease Control (CDC) the cost of obesity in 1998 was $78.5 billion.Four state areas are served by the James H. Quillen Medical Center and include East Tennessee,Southeastern Kentucky, Southwestern Virginia, and Northwestern North Carolina. The cost of obesity for each of these states is: Tennessee $ 1.84 billion, North Carolina $ 2.14 billion,Kentucky $1.16 billion, and Virginia $ 1.64 billion. 7

Risk factors for obesity :

Genetics can affect obesity in that genes can affect how much body fat an individual stores andwhere the fat is stored. 8

1. Family history can affect obesity in that obesity tends to run in families. This can bebecause of environment or genetics. 8

2. Age can also affect obesity in that hormonal changes and decreased activity can increaseand individuals weight. Also, muscle mass decreases as you age further decreasing theability to burn off calories. If a decrease in calorie intake doesnt occur, then theindividual will have increased difficulty with maintaining their weight. 8

3. Socioeconomic issues also play a part in obesity in that access to safe areas to exercise,limited access to healthy cooking, and lack of availability to fresh non-processed foods allplay a role in obesity. Much like family, peer groups can influence health behaviors. If individuals associate with obese friends, then they are more likely to be obese. 8

Prevalence of Obesity:

Body mass index (BMI) is used to express the relationship between height and weight of individuals. The prevalence of overweight (BMI above 25 and below 30) and obesity (BMI above

30) in the United States is 32.2% and 35.1% respectively. That is to say that in the United Stateshas 67.3% of individuals have a BMI of 25 or above. 8 Among American veterans being served atVeterans Administration medical facilities 73.0% had a BMI above 25 or above and 32.9% had aBMI above 30. 9 For the four state areas that are treated at the James H. Quillen VeteransAdministration Medical Center the obesity rates are as follows: Tennessee 30.6%,

Kentucky 29.8%, Virginia 25.0%, and North Carolina 29.0%. 9

Morbidity and Mortality with Obesity:


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In a large cohort study it was found that statistically an increase in weight during midlife had andincreased risk of death. 10 The Surgeon General states that one out of every eight deaths inAmerica is caused by an illness directly related to overweight and obesity. 11

With obesity comes increased in risk of disease such as diabetes 2,7 ,12 , hypertension, heartdisease, stroke, sleep apnea, hyperlipidemia, depression, gall bladder and liver disease 7 , some of which can lead to death 10 . The increase in upper body obesity has shown an increase in insulinresistance 7 . Obesity is a major health hazard and is associated with several diseases such ashypertension, heart disease, and some cancers 2. Obesity has been shown to be related toincreased prostate-specific antigen (PSA) which may indicate an increase a higher tumor burden.

This same study states that obese men had a more aggressive form of prostate cancer. Theauthors speculated that this could be related to obesity and increased PSA or secondary to laterdetection. 13 The risk of death in obese persons increased in overweight and obese people by upto 40% . 8

Medical treatment:

Medical use of drugs for obesity has been established to be effective especially with behavioraltreatment. The early medications to treat obesity were Fenfluramine and Phentermine. Thesehowever turned out to lead to cardiovascular disease and were pulled off the market as obesitytreatments. Other drugs to treat obesity are Benzphetamine, Phendimetrazine, Diethylpropion,Sibutramine and Orlistat. Benzphetamine, Phendimetrazine, Diethylpropion, and Sibutramine allhave contraindications to not be used with people with hypertension, cardiovascular disease,glaucoma, agitated state and history of drug abuse. The use of Sibutramine has additionalcontraindications of congestive heart failure and stroke. The use of Orlistat has acontraindication of malabsorption syndromes. Only Orlistat and Sibutramine are able to be usedon a long term basis. 14

Physical Therapy treatment:

The practice patterns for obesity according to the Guide to Physical Therapist Practice would be6A, and 7A. 15 The therapy approaches to obesity have been to increase the individuals activity.In doing so the therapist needs to take into account many factors affecting the individualshealth including other risk factors and age. 16 In a study by Blair and Brodney it wasdemonstrated that active obese individuals had lower morbidity or mortality rates than inactiveobese individuals. The study also demonstrated that the active obese individual had lowermorbidity and mortality rates than normal weight individuals that were inactive .17 In developedcountries the work and daily activies have lead to low daily energy expenditure. At the sametime in developed countries there is an abundance of inexpensive high calorie food. This leadsto a energy balance that increases the prevalence of obesity. 18 Individuals that have electric

mobility devices are more likely to have decreased activity levels than individuals that userollator walkers to get around. This has not been studied and therefore leads to the question of whether this is true or not.

Problem statement:

Does the use of electric mobility devices cause an increase in weight as compared to use of arollator walker in veterans being treated at a Veterans Administration Medical Center?


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2. SPECIFIC AIMS This study has the aim of investigating whether there is arelationship between the issuing of electric mobility and weight gain. This study also wishes to

establish whether individuals who use rollator walkers for mobility have a weight gain and if theydo, then is it less than that of the electric mobility group.

3. EXPERIMENTAL PROTOCOL

Sample Protocol: The study to be performed involves sampling the individualsthat have received electric mobility and rollator walkers from January 1 st 2006 through December31 st 2006. The individuals will have be selected 1 st by being issued electric mobility or rollatorwalkers. Then they will be selected based on whether they meet the criteria for inclusion withouthaving the conditions that would lead to exclusion. Exclusion criteria from this study areconditions that would be indicated to cause weight loss or weight fluctuation. These includecongestive heart failure (CHF) 19 , malnutrition, drug or alcohol abuse, thyroid disease, acquiredimmune deficiency syndrome AIDS, malignancy, chronic diarrhea, eating disorders, acuteinfection at times of weighing patient, and chronic infection. 20 These data sets will then bestatistically compared using ANOVA or t-test. The results will then be interpreted to eitheraccept or reject the hypothesis.

4 INTERPRETATION OF DATA - With the t-test the null hypothesis is [There will be nostatistical difference in weight gain between the group that is issued a scooter and thegroup that is issued a rollator walker]. If the p-value is less that .05 then the nullhypothesis is rejected and if the p- value is greater than .05 then the null hypothesis isaccepted.

5 RISKS The only risk of this research would be the use of the veterans medical record. The way that this risk will be reduced is by making each veteran a subject # and notusing personal identification information in this study. The information that will beused are the age and weight gain after the issuing of the mobility device. Thephysician has full access to the medical record and will therefore be able to see anyproblems associated with weight gain.

6 POTENTIAL BENEFITS The potential benefit for this study would be increasedinformation in regaurds to the relationship between electric mobility and weight gain.If it is shown to be statistically significant then it may insire further research in thearea. This could in turn assist individuals and providers to think twice before issuingelectric mobility devices. The individuals will have more information on the risks of electric mobility compared to the risks of not having electric mobility.


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7 INFORMED CONSENT A HIPPA waiver was attained secondary to no personalidentification information being involved in the study.


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Part C: Laboratory Services (to be completed if laboratory services are to be used):

1. Will any tests be performed that are not normally included as part of a diagnostic work-upor treatment? Yes No

2. What tests will be performed as part of this study? NA

3. Who or what agency will pay for the above tests? NA Please specify in the spaceprovided.

Grant ( )

Medicaid/Medicare

Insurance ( )

General Funds

Patient/Subject

Other ( NA )


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14 Yanovski SZ. Yanovski JA. Wood AJJ ed. Obesity. N Engl J Med, Vol.346(8): 591-602. Feb21,2002.

15 Guide to Physical Therapist Practice. 2nd Ed. Phys Ther. 2001; 81:9 - 744

16 Resnick B. Ory M. Rogers ME. etal. Screening for and Prescribing Exercise for Older Adults.Geriatrics and Aging, vol9(3):174-182, 2006.

17 Blair SN, Brodney S. Effects of physical inactivity and obesity on morbidity and mortality: current evidence and research issues. Med Sci Sports Exerc. 31(11 Suppl):S646-662. Nov 1999.

18 Blair SN, Church TS. The Fitness, Obesity, and Health Equation. Is physical activity thecommon denominator? JAMA. 292(10):1232-1234. Sep 8, 2004.

19 Congestive heart failure, available at: http://www.hmc.psu.edu/healthinfo/c/chf.htm . Accessed11/22/09.

20 Weight loss unintentional available at: http://www.healthcentral.com/ency/408/003107.htmlAccessed 11/17/09 .

Table 1Electric mobility

SUBJECTS

AGE

WEIGHT AT TIME OF ORDERING OF EQUIPMENT.

WEIGHT AT LEAST SIX MONTH AFTER ISSUING OF EQUIPMENT.

DIFFERENCE IN WEIGHT.

Mean weight difference by decades.

# 2
http://www.hmc.psu.edu/healthinfo/c/chf.htmhttp://www.hmc.psu.edu/healthinfo/c/chf.htmhttp://www.healthcentral.com/ency/408/003107.html%20Accessed%2011/17/09http://www.healthcentral.com/ency/408/003107.html%20Accessed%2011/17/09http://www.hmc.psu.edu/healthinfo/c/chf.htmhttp://www.healthcentral.com/ency/408/003107.html%20Accessed%2011/17/09http://www.healthcentral.com/ency/408/003107.html%20Accessed%2011/17/09


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50

245

249

4

# 18

50

210

210

0

# 5

51

180

186

6

# 15

52

190

190

0


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50's

4

# 14

53

270

277

7

60's

4

# 25

54

124

130

6

70's

0

# 28

54

180

191

10

80's

4.5

# 29

55

222


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225

4

# 20

56

145

150

5

# 8

57

145

145

0

# 19

58

220

222

2


18/41

# 16

61

190

193

3

# 24

61

222

227

5

# 7

62

201

212

11

# 9

62

167

172

5


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20/41

222

225

3

# 21

64

189

193

4

# 22

64

333

331

-2

# 26

66

240

250

10


21/41

# 3

67

199

199

0

# 6

71

190

191

1

# 12

71

185

183

-2

# 27

71

260

261


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1

# 17

72

288

292

4

# 30

77

212

212

0

# 4

81

167

173

4

# 23


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81

189

195

5

Table 2Rollator Walker

SUBJECTS

AGE

WEIGHT AT TIME OF ORDERING OF EQUIPMENT.

WEIGHT AT LEAST SIX MONTH AFTER ISSUING OF EQUIPMENT.

DIFFERENCE IN WEIGHT.

Mean weight difference by decades.

# 9

43

167

172

5

# 18

47


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277

278

1

# 11

48

240

240

0

# 2

50

245

247

3

40's

2

# 15

50

198

195

-1

50's


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2.1

# 32

50

300

299

-1

60's

1

# 5

51

180

186

6

70's

2.166666667

# 8

53

155

154

3

80's

2.8

# 14

53

320

323


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3

# 25

54

205

203

2

# 28

54

173

177

4

# 29

55

153

152

1

# 22


27/41

57

177

174

1

# 16

61

202

200

0

# 7

62

210

212

2

# 13

63

267

168

1


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# 1

64

219

221

2

# 10

66

240

243

1

# 26

66

232

232

1

# 3

67

189


29/41

190

1

# 24

69

180

180

0

# 6

71

190

191

1

# 27

71

180

185

5


30/41

# 23

72

165

169

4

# 21

76

180

179

-1

# 20

77

155

157

2

# 30

77

149

150

2


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# 4

81

165

170

5

# 19

82

187

190

3

# 17

84

390

390

3

# 31

86


32/41


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4

5

F-Test Two-Sample for Variances

0

1

6

0

Variable 1

Variable 2

0

3

Mean

3.6

1.9375

7

-1

Variance


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12.73103

3.350806

6

-1

Observations

30

32

11

6

df

29

31

3

3

F

3.799394

5

3

P(F


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F Critical one-tail

1.834937

2

4

3

1

t-Test: Two-Sample Assuming Unequal Variances

5

1

11

0

Variable 1

Variable 2

5

2

Mean


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3.6

1.9375

2

1

Variance

12.73103

3.350806

10

2

Observations

30

32

1

1

Hypothesized Mean Difference

0

3

1

df

43

4

1


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t Stat

2.285603

-2

0

P(T


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1

2

4

2

1

5

4

3

3


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3

2

1

Mean

Mean

3.6

1.9375


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ProductThe individuals for this study were selected by being issued either electric mobility or rollator walker

between 01/01/07 and 12/31/07. The information was acquired though the prosthetics department atthe James H. Quillen Medical Center. The Veterans had to meet all the inclusion criteria in order to beissued a rollator walker or electric mobility device. The charts of these individuals were then reviewed

in order to ascertain whether they needed to be excluded from the study. The veterans were thenexcluded using the exclusion criteria listed above in order not to skew the data in either direction. Theindividuals that were included in the study then, had their charts further reviewed to get the weight of the individual when the assistive device was first ordered and then at least 6 months after issuing of thedevice. The difference in weight was then taken for each individual between the weight the individualwas upon ordering of the device and the weight of the individual at least 6 months after receiving thedevice. The two groups weight differences were then compared.[table 3] During the comparison thevariance of both groups was calculated. Then a t-test was run on the weight differences in both groups.See table 3 in the appendix. The t-test calculated out to be P = 0.027. This calculation being less than .05 meaning that the null hypothesis was rejected. That is to say that it demonstrates that there is a

significant difference between the two groups.

The first group consisted of individuals issued electric mobility; the total number of individuals issuedelectric mobility was 71. Of the individuals issued electric mobility 41 were eliminated secondary tothe exclusion criteria leaving the study size of n = 30. [table 1] The second group consisted of individuals issued rollator walkers; the total number of individuals issued rollator walkers was 82. Theindividuals were then excluded with the use of the exclusion criteria were 50. This gave a rollator walker study size of n = 32. [table 2]

The electric mobility group age range was from 50 to 81 years old. The rollator walker group agerange was from 43 88 years old.

The mean weight change for the electric mobility group was 3.6 lbs and for the rollator walker groupwas 1.94 lbs. The variance was 12.73 in the electric mobility group and 3.35 in the rollator walker group. The F-test was performed and p = .0002 this indicated a significant difference between thevariances of the weight distribution. The t test was run using the differences in weight in the twocategories. The t test is a 2 tailed test between groups with the assumption of unequal variance basedon the F-test. This test demonstrated a t-test value of P = 0.027. The .027 value is less than .05 andtherefore, the null hypothesis is rejected. There is a significant difference between the variances of theweight distribution between the two data sets. See table 3 in appendix.

In this formula f = the variance of group 1 over the variance of group 2.


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In this formula t = the mean of group 1 the mean of group 2 over the square root of the variance of group 1 over the number of subjects in group 1 + the variance of group 2 over the number of subjects ingroup 2.

F-test formula available at:http://support2.dundas.com/OnlineDocumentation/WebChart2005/FTest.html . Accessed 11/29/09.T-test formula available at: http://www.socialresearchmethods.net/kb/stat_t.php . Accessed 11/29/09.
http://support2.dundas.com/OnlineDocumentation/WebChart2005/FTest.htmlhttp://support2.dundas.com/OnlineDocumentation/WebChart2005/FTest.htmlhttp://www.socialresearchmethods.net/kb/stat_t.phphttp://support2.dundas.com/OnlineDocumentation/WebChart2005/FTest.htmlhttp://www.socialresearchmethods.net/kb/stat_t.php

Budget for Project $188.0 0 $1,607. 65 $44.98 $749.2 5

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