Yoga Therapy and Aerobic Exercise on Anti-Mullerian Hormone in Young Women With Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
Weight loss and lifestyle modifications are much required in women with Polycystic ovarian syndrome (PCOS). Yoga has gained great importance as an alternate medicine in recent years which is helpful in lifestyle modifications. Weight loss can be achieved by regular aerobic activity. In recent years, excessive production of anti-mullerian hormone (AMH) has been considered as the etiology of PCOS. AMH is also emerging as a diagnostic and screening tool for PCOS. Effect of yoga therapy on adolescent girls have proved to be effective. But, researches on young women undergoing yoga therapy and combined effect of aerobic exercise and yoga therapy are still lacking. Hence, the investigators aimed t o establish the benefits of yoga therapy and aerobic exercise on Anti-Mullerian Hormone and other biochemical markers in young women with polycystic ovary syndrome.

Detailed Description
-----------------
A total of 128 female with PCOS will be recruited by the simple random sampling (random number generator) to participate in randomized, single blind randomized controlled, study. Recruited patients with 128 female with PCOS will be randomly divided into four groups, yoga therapy (YT) group, aerobic exercise (AE) group, combined YT and AE (cYTAE) group and control group. Duration of the intervention will be 60 minutes in one session for 6 days/week for 12 weeks. Thus, each women with PCOS will receive 72 sessions in total, except in control group. Anti-Müllerian hormone (AMH) and other biochemical markers such as, Follicle-stimulating hormone (FSH), Luteinizing hormone (LH), Testosterone, Prolactin, Thyroid-stimulating hormone (TSH) Ultrasensitive, Dehydroepiandrosterone sulfate (DHEAS), insulin fasting, glucose fasting, HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) and the lipid profiles which includes, total cholesterol, High-density lipoprotein cholesterol (HDL-C), Low-density lipoprotein cholesterol (LDL-C) and serum triglycerides. In addition to the above biochemical markers, transvaginal ultrasound to estimate antral follicle count (AFC) will be recorded at baseline and at the end of 12-week post-intervention period. Following the 12-week intervention, follow-up of another 12-week will be carried out to determine the retention of treatment effects.

Official Title
-----------------
Yoga Therapy and Aerobic Exercise on Anti-Mullerian Hormone and Other Biochemical Markers in Young Women With Polycystic Ovary Syndrome

Conditions
-----------------
Polycystic Ovary Syndrome, Anti-Mullerian Hormone Deficiency, Female Infertility Endocrine

Intervention / Treatment
-----------------
* Other: Structured yoga therapy program
* Other: Aerobic exercise training program
* Other: Combined yoga and aerobic training program
* Other: Nutritional management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female in age between 18 and 30 years Female with at least two-thirds of the features listed in the Rotterdam criteria for PCOS were included in the study Oligomenorrhea or amenorrhea (an absence of menstruation for 45 or more days and/or fewer than 9 menses per year) Hyperandrogenism (a score of 8 or higher ( ≥ 8) on the modified Ferriman-Gallwey scale) Polycystic ovaries (presence of more than 12 cysts < 9 mm in diameter in single ovary, usually combined with an ovarian volume > 10 ml Exclusion Criteria: On regular hormonal treatment Oral contraceptives Insulin-sensitizing agents in the previous 6 weeks Smoking in less than 48 hours Alcohol in less than 48 hours History of thyroid abnormalities Practicing regular yoga asanas and pranayama Regular aerobic training program

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Recruited female with PCOS with 128 female with PCOS will be randomly divided into four parallel groups, yoga therapy (YT) group, aerobic exercise (AE) group, combined YT and AE (cYTAE) group and control group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga therapy group<br>Structured yoga therapy program for 60 minutes six days per week for 12 weeks and nutritional management uniquely prepared by dietitian | Other: Structured yoga therapy program<br>* Structured yoga therapy prepared according to traditional yoga scriptures of Patanjali yoga sutras will be administered to 32 females with PCOS. The structured yoga therapy which includes, Surya Namaskara (Sun Salutation) and asanas performed in four positions, standing, sitting, supine and prone for total duration of 60 minutes. In addition to this, they will be asked to undergo nutritional management uniquely prepared by dietitian<br>|
| Experimental: Aerobic exercise group<br>Aerobic training of moderate intensity for 30-60 minutes six days per week for 12 weeks and nutritional management uniquely prepared by dietitian | Other: Aerobic exercise training program<br>* Thirty two females with PCOS in aerobic exercise (AE) group will be subjected to aerobic training of moderate intensity for 30-60 minutes six days per week for 12 weeks, in the light of guidelines framed by American College of Sports Medicine (ACSM). Aerobic exercise volume for each female recruited will be set at greater than 500 and up to 1000 MET-min/week, which will be approximately equal to 1000 kcal/week. They will be made sure that they exercise for minimum duration of 150 min/week and thereby covering 5400 to 7900 steps/day in pedometer readings. In addition to this, they will be asked to undergo nutritional management uniquely prepared by dietitian<br>|
| Experimental: Combined yoga therapy and aerobic exercise group<br>Combined yoga therapy for three days and vigorous aerobic exercise program for three days with nutritional management uniquely prepared by dietitian | Other: Combined yoga and aerobic training program<br>* Thirty two females with PCOS in combined yoga therapy and aerobic exercise (cYTAE) group will be subjected to three days of structured yoga therapy and three days of aerobic training of vigorous intensity. In addition to this, they will be asked to undergo nutritional management uniquely prepared by dietitian<br>|
| Active Comparator: Control group<br>Nutritional management uniquely prepared by dietitian | Other: Nutritional management<br>* Thirty two females with PCOS will be asked to undergo only nutritional management uniquely prepared by dietitian<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Anti-Mullerian hormone Concentration | Serum Anti-Mullerian hormone will be determined by blinded lab technician | Change from Baseline Serum Anti-Mullerian hormone Concentration at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antral follicle count | Antral follicle count will be determined by blinded gynaecologist | Change from Baseline Antral follicle count at 12 weeks | 
| Serum Follicle-stimulating hormone Concentration | Serum Follicle-stimulating hormone will be determined by blinded lab technician | Change from Baseline Serum Follicle-stimulating hormone Concentration at 12 weeks | 
| Serum Luteinizing hormone Concentration | Serum Luteinizing hormone will be determined by blinded lab technician | Change from Baseline Serum Luteinizing hormone Concentration at 12 weeks | 
| Serum Testosterone Concentration | Serum Testosterone will be determined by blinded lab technician | Change from Baseline Serum Testosterone Concentration at 12 weeks | 
| Serum Prolactin Concentration | Serum Prolactin will be determined by blinded lab technician | Change from Baseline Serum Prolactin Concentration at 12 weeks | 
| Serum Thyroid-stimulating hormone Concentration | Serum Thyroid-stimulating hormone will be determined by blinded lab technician | Change from Baseline Serum Thyroid-stimulating hormone Concentration at 12 weeks | 
| Serum Dehydroepiandrosterone sulfate Concentration | Serum Dehydroepiandrosterone sulfate will be determined by blinded lab technician | Change from Baseline Serum Dehydroepiandrosterone sulfate Concentration at 12 weeks | 
| Serum Insulin fasting Concentration | Serum Insulin fasting will be determined by blinded lab technician | Change from Baseline Serum Insulin fasting Concentration at 12 weeks | 
| Serum Glucose fasting Concentration | Serum Glucose fasting will be determined by blinded lab technician | Change from Baseline Serum Glucose fasting Concentration at 12 weeks | 
| Homeostatic Model Assessment for Insulin Resistance | Homeostatic Model Assessment for Insulin Resistance will be determined by blinded lab technician | Change from Baseline Homeostatic Model Assessment for Insulin Resistance at 12 weeks | 
| Concentration of Lipid profiles in serum | Serum total cholesterol, Serum High-density lipoprotein cholesterol, Serum Low-density lipoprotein cholesterol and serum triglycerides | Change from Baseline Concentration of Lipid profiles in serum at 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Yoga therapy, Aerobic exercise training, Aerobic exercise, Aerobic training, Polycystic ovary syndrome, Antimullerian hormone