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

Maharishi Markendeswar University (Deemed to be University)128 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Interventions

Structured yoga therapy programOTHER

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

Aerobic exercise training programOTHER

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

Combined yoga and aerobic training programOTHER

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

Nutritional managementOTHER

Thirty two females with PCOS will be asked to undergo only nutritional management uniquely prepared by dietitian

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 30 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Serum Anti-Mullerian hormone Concentration

Serum Anti-Mullerian hormone will be determined by blinded lab technician

Time frame: Change from Baseline Serum Anti-Mullerian hormone Concentration at 12 weeks

Secondary Outcomes

Antral follicle count

Antral follicle count will be determined by blinded gynaecologist

Time frame: 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

Time frame: 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

Time frame: Change from Baseline Serum Luteinizing hormone Concentration at 12 weeks

Serum Testosterone Concentration

Serum Testosterone will be determined by blinded lab technician

Time frame: Change from Baseline Serum Testosterone Concentration at 12 weeks

Serum Prolactin Concentration

Serum Prolactin will be determined by blinded lab technician

Time frame: 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

Time frame: 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

Time frame: Change from Baseline Serum Dehydroepiandrosterone sulfate Concentration at 12 weeks

Serum Insulin fasting Concentration

Serum Insulin fasting will be determined by blinded lab technician

Time frame: Change from Baseline Serum Insulin fasting Concentration at 12 weeks

Serum Glucose fasting Concentration

Serum Glucose fasting will be determined by blinded lab technician

Time frame: 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

Time frame: 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

Time frame: Change from Baseline Concentration of Lipid profiles in serum at 12 weeks