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

NCT04335227 | Unknown DMC

• 1 other identifier: MMDU/IEC/141E
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

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.

Conditions

Polycystic Ovary Syndrome; Anti-Mullerian Hormone Deficiency; Female Infertility Endocrine

Keywords

Yoga therapy; Aerobic exercise training; Aerobic exercise; Aerobic training; Polycystic ovary syndrome; Antimullerian hormone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Antral follicle count

  Change from Baseline Antral follicle count at 12 weeks

• Serum Follicle-stimulating hormone Concentration

  Change from Baseline Serum Follicle-stimulating hormone Concentration at 12 weeks

• Serum Luteinizing hormone Concentration

  Change from Baseline Serum Luteinizing hormone Concentration at 12 weeks

• Serum Testosterone Concentration

  Change from Baseline Serum Testosterone Concentration at 12 weeks

• Serum Prolactin Concentration

  Change from Baseline Serum Prolactin Concentration at 12 weeks

Study Arms (4)

Yoga therapy group

EXPERIMENTAL

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

Aerobic exercise group

EXPERIMENTAL

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

Combined yoga therapy and aerobic exercise group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

Nutritional management uniquely prepared by dietitian

Other: Nutritional management

Interventions

Structured yoga therapy program OTHER

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

Yoga therapy group

Aerobic exercise training program OTHER

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

Aerobic exercise group

Combined yoga and aerobic training program OTHER

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

Combined yoga therapy and aerobic exercise group

Nutritional management OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: Female with polycystic ovarian syndrome
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maharishi Markendeswar University (Deemed to be University): lead

Study Sites (2)

Maharishi Markandeshwar Hospital, Mullana

Ambāla, Haryana, 133207, India

Location

Maharishi Markandeshwar Medical College & Hospital, Kumarhatti

Solan, Himachal Pradesh, 173229, India

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Diet

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Asir J Samuel, MPT, PhD

  Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, Mullana

  PRINCIPAL INVESTIGATOR

• Unmesh Santpur, MBBS, MD

  Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana

  STUDY DIRECTOR

• Kiranjeet Kaur, MBBS, MD

  Maharishi Markandeshwar Medical College & Hospital, Solan

  STUDY CHAIR

Central Study Contacts

Asir J Samuel, MPT, PhD

CONTACT

+918059930222; asirjohnsamuel@mmumullana.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Lab technician who test the blood samples of the female with Polycystic Ovary Syndrome (PCOS) will be blinded to the trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: April 6, 2020
• Study Start: November 14, 2021
• Primary Completion: March 12, 2023
• Study Completion: April 14, 2023
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)