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

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

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.

Study Overview

• Status: Not yet recruiting
• 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

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.

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asir J Samuel, MPT, PhD; Phone Number: +918059930222; Email: asirjohnsamuel@mmumullana.org

Study Locations

• India
  • Haryana
    • Ambala, Haryana, India, 133207
      • Maharishi Markandeshwar Hospital, Mullana
      • Contact: Asir J Samuel, MPT, PhD; Phone Number: 08059930222; Email: asirjohnsamuel@mmumullana.org
      • Contact: Email: asirjohnsamuel@mmumullana.org
      • Principal Investigator: Asir J Samuel, MPT, PhD
      • Sub-Investigator: Unmesh Santpur, MBBS, MD
  • Himachal Pradesh
    • Solan, Himachal Pradesh, India, 173229
      • Maharishi Markandeshwar Medical College & Hospital, Kumarhatti
      • Principal Investigator: Asir J Samuel, MPT, PhD
      • Contact: Kiranjeet Kaur, MBBS, MD; Email: principal.mmmch@mmusolan.org
      • Sub-Investigator: Kiranjeet Kaur, MBBS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yoga therapy group; 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; 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
Experimental: Aerobic exercise group; 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; 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
Experimental: Combined yoga therapy and aerobic exercise group; 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; 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
Active Comparator: Control group; Nutritional management uniquely prepared by dietitian	Other: Nutritional management; Thirty two females with PCOS will be asked to undergo only nutritional management uniquely prepared by dietitian

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

Collaborators and Investigators

• Sponsor: Maharishi Markendeswar University (Deemed to be University)
• Investigators: Principal Investigator: Asir J Samuel, MPT, PhD, Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation, Mullana; Study Director: Unmesh Santpur, MBBS, MD, Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana; Study Chair: Kiranjeet Kaur, MBBS, MD, Maharishi Markandeshwar Medical College & Hospital, Solan

Study record dates

Study Major Dates

• Study Start (Anticipated): November 14, 2021
• Primary Completion (Anticipated): March 12, 2023
• Study Completion (Anticipated): April 14, 2023

Study Registration Dates

• First Submitted: March 27, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 22, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Aerobic exercise; Aerobic training; Polycystic ovary syndrome; Yoga therapy; Aerobic exercise training; Antimullerian hormone
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome; Infertility; Infertility, Female
• Other Study ID Numbers: MMDU/IEC/141E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Not now

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No