62 4. AIM AND OBJECTIVES 4.1 Aim of the research 1. To study and compile the available literature from traditional yogic scriptures on Polycystic Ovarian Syndrome. 2. To find the prevalence of Polycystic Ovarian Syndrome among Indian adolescents. 3. To assess the effect of yoga based lifestyle program on adolescent Polycystic Ovarian Syndrome, through a randomized control trial. 4.2 Objectives: 1. To explore the understanding of Polycystic Ovarian Syndrome according to traditional yogic scriptures. 2. To estimate the prevalence of Polycystic Ovarian Syndrome among adolescent girls in South India. 3. To investigate the effects of 12 weeks of integrated approach of yoga therapy (IAYT) as a yoga based lifestyle program on clinical symptoms of adolescent polycystic ovarian syndrome. 4. To study the changes in hormonal profile in PCOS adolescents after 12 weeks of IAYT as a yoga based lifestyle program. 5. To assess the biochemical changes after 12 weeks of IAYT as a yoga based lifestyle program on adolescent PCOS. 6. To study the effect of 12 weeks of IAYT as a yoga based lifestyle program on psychological wellbeing of adolescent PCOS.
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4. AIM AND OBJECTIVES
4.1 Aim of the research
1. To study and compile the available literature from traditional yogic scriptures on
Polycystic Ovarian Syndrome.
2. To find the prevalence of Polycystic Ovarian Syndrome among Indian adolescents.
3. To assess the effect of yoga based lifestyle program on adolescent Polycystic Ovarian
Syndrome, through a randomized control trial.
4.2 Objectives:
1. To explore the understanding of Polycystic Ovarian Syndrome according to traditional
yogic scriptures.
2. To estimate the prevalence of Polycystic Ovarian Syndrome among adolescent girls in
South India.
3. To investigate the effects of 12 weeks of integrated approach of yoga therapy (IAYT)
as a yoga based lifestyle program on clinical symptoms of adolescent polycystic
ovarian syndrome.
4. To study the changes in hormonal profile in PCOS adolescents after 12 weeks of
IAYT as a yoga based lifestyle program.
5. To assess the biochemical changes after 12 weeks of IAYT as a yoga based lifestyle
program on adolescent PCOS.
6. To study the effect of 12 weeks of IAYT as a yoga based lifestyle program on
psychological wellbeing of adolescent PCOS.
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4.3 Research Questions:
PART 1
Is the prevalence of PCOS in South Indian adolescents similar to the other countries?
PART 2
Is IAYT as/more effective than physical exercise therapy in improving clinical, hormonal,
biochemical and psychological functions in adolescent girls with PCOS?
4.4 Hypothesis:
4.4.1 PART 1: Prevalence of PCOS in Adolescent Girls
There was no hypothesis testing involved in the study as it was an effort to evaluate the
prevalence of the syndrome amongst the population that was being screened for the
interventional study.
4.4.2 PART 2: Effect of yoga on PCOS
The study hypothesized that in comparison to the matched control group practices, IAYT
practice would improve the clinical, hormonal, biochemical and psychological functions in
South Indian adolescent girls with PCOS.
4.4.3 Null hypothesis:
The yoga group will show changes similar to control group in clinical, hormonal,
biochemical and psychological functions.
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5. METHODOLOGY OF EXPERIMENTAL RESEARCH
5.1 Subjects
The study was carried out on adolescent girls aged 15 to 18 years from a residential
college in Anantpur, Andhra Pradesh, India. Although they were students of one residential
college in Anantpur, they represented a larger geographical area as they were from semi-
urban and rural areas around the district.
5.1.1 Sample size
A sample size of 86 with 43 subjects in each arm of the study, was calculated keeping an
effect size of 0.61, with Type 1 error at 0.05 and power at 0.8. This effect size of 0.61 was
obtained by using mean and Standard Deviation values of testosterone after 6 months of
lifestyle modification and metformin compared to placebo in a study on obese PCOS women
(Tang T, Glanville J et al. 2006). For these calculations we used the noncommercial statistical
power analysis program G*Power (Faul F, Erdfelder E et al. 2009 Nov). The sample size that
was actually recruited was 90 subjects.
5.1.2 Source of subjects
Female students from Sri Sai residential college, Anantpur, Andhra Pradesh, South India
were screened and subsequently recruited into the study.
5.1.3 Selection Criteria
5.1.3.1 Inclusion Criteria
1. Adolescent girls aged 15-18 years
2. Girls with no prior experience of yoga.
3. Girls with BMI≥18.5.
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4. Those who satisfied the Rotterdam criterion for PCOS were included in the study.
The following were the definitions of the features:
a. Oligo/amenorrhea: absence of menstruation for 45 days or more and/or less
than eight menses per year (Kumarapeli V, Seneviratne RD et al. 2008).
b. Clinical hyperandrogenism: Modified Ferriman and Gallway (mFG) score
of 6 or higher (Chen X, Yang D et al. 2008). Using17 mF-G, some
researchers reported a value as low as 3, being abnormal. However, other
investigators have used the 95th 18 percentile of controls as the upper
normal limit, which 19 corresponds to an mF-G score of 6-8 in the
population studied. We used an mF-G score of 6 as the upper normal limit
in accordance with a study in South Asia by Chen et al (Chen X, Yang D et
al. 2008) since there are no studies defining the criteria for hirsutism in
Indian girls.
c. Biochemical hyperandrogenism: Serum testosterone level of > 82ng/dl in
the absence of other causes of Hyperandrogenism.
d. Polycystic ovaries: presence of >10 cysts, 2-8mm in diameter, usually
combined with increased ovarian volume of >10cm3, and an echo-dense
stroma in pelvic ultrasound scan (Franks S, Gharani N et al. 1997).
5.1.3.2 Exclusion Criteria
1. Girls who fall under Rotterdam criteria of exclusion.
2. Girls with BMI<18.5.
3. Girls who were using oral contraceptives/hormone treatment/insulin-sensitizing
agents within previous 6 weeks.
4. Girls who were practicing yoga from a month or more.
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5.2 Ethical clearance and consent
The study was approved by the Institutional Ethical Committee of Swāmi Vivekānanda
Yoga Anusandhāna Samsthāna (SVYASA) University. The college administration also gave
the ascent for the study. Signed Informed consent was obtained from the student and one of
the parents. The consent form had clearly stated about the randomized allotment to either of
the interventions. The utility of the control session as a conventionally accepted therapeutic
regime (not as a placebo waiting period) was clarified so that they could participate in both
the interventions with equal degree of motivation.
5.3 Screening
All female students of standard 11 and 12 attended an interactive introductory lecture
where the purpose and design of the study were elucidated. They were asked to report one
week later after obtaining the signed consent from their parents.
All girls who consented for the study were asked to fill up a short PCOS symptoms check
list that asked questions on the pattern of menstrual cycle, hirsutism, acne, alopecia,
acanthosis nigricans and information about past diagnosis or treatment of PCOS or any other
illnesses. After one week, individual interviews were conducted to confirm statements in the
check list. The research medical officer conducted a physical examination to look for external
features of PCOS and also to exclude other conditions that could mimic PCOS such as
Cushing’s syndrome, adrenal Hyperplasia or androgen producing neoplasm. Questions were
asked about the use of Oral Contraceptive Pills or any other hormones that could affect the
length of the menstrual cycle. Self–reported degree of hirsutism was assessed using modified
Ferriman-Gallwey (mF-G) scoring method. The girls were asked to compare the amount of
body hair they had with a chart of pictures displaying the degree of hair growth in nine
regions (i.e., upper lip, chin, chest, upper and lower abdomen, upper and lower back, upper
arms, and thighs). Hirsutism scores recorded by the girls were checked for accuracy during
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clinical examination by the researcher and corrected with the consent of the participant when
deemed necessary.
Also girls were asked about the presence of acne or hair fall from the scalp although it was
not quantified. All girls with Oligomenorrhea and/or hirsutism (as per the above said
definitions) were asked to come for pelvic ultrasound and biochemical investigations.
5.4 Design of the study
This was a prospective, randomized, active interventional controlled trial in which 90
participants were randomly divided into two study arms: one arm practiced yoga based life
style modification and the other arm practiced physical exercise based lifestyle modification,
in the absence of any conventional treatment, for the same duration.
5.5 Randomization
PCOS girls were randomly assigned to two groups of 45 numbers each by using a
computer-generated random number table (www.randomizer.org ) by the pre labeled sealed
envelope method.
5.6 Blinding and Masking
Double blinding was not possible as this was an interventional study. The medical officer,
ultrasonologist and the laboratory staff were blind to the groups. Also the statistician who did
the randomization and the final analysis was blind to the source of the data. The
questionnaires’ coded answer sheets were analyzed only after completion of the study.
5.7 Variables
Variable of the study was specifically chosen to provide a comprehensive picture of the
changes that were brought about by the intervention. Since IAYT has effects at several levels,
it was deemed essential to select variables that could capture them. This battery of variables