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

NCT ID: NCT04335227

Last Updated: 2021-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-14

Study Completion Date

2023-04-14

Brief Summary

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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

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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.

Conditions

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Polycystic Ovary Syndrome Anti-Mullerian Hormone Deficiency Female Infertility Endocrine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Lab technician who test the blood samples of the female with Polycystic Ovary Syndrome (PCOS) will be blinded to the trial

Study Groups

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Yoga therapy group

Structured yoga therapy program for 60 minutes six days per week for 12 weeks and nutritional management uniquely prepared by dietitian

Group Type EXPERIMENTAL

Structured yoga therapy program

Intervention Type 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

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

Group Type EXPERIMENTAL

Aerobic exercise training program

Intervention Type 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

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

Group Type EXPERIMENTAL

Combined yoga and aerobic training program

Intervention Type 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

Control group

Nutritional management uniquely prepared by dietitian

Group Type ACTIVE_COMPARATOR

Nutritional management

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Nutritional management

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Maharishi Markendeswar University (Deemed to be University)

OTHER

Sponsor Role lead

Responsible Party

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Asir John Samuel

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Asir J Samuel, MPT, PhD

Role: PRINCIPAL_INVESTIGATOR

Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, Mullana

Unmesh Santpur, MBBS, MD

Role: STUDY_DIRECTOR

Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana

Kiranjeet Kaur, MBBS, MD

Role: STUDY_CHAIR

Maharishi Markandeshwar Medical College & Hospital, Solan

Locations

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Maharishi Markandeshwar Hospital, Mullana

Ambāla, Haryana, India

Site Status

Maharishi Markandeshwar Medical College & Hospital, Kumarhatti

Solan, Himachal Pradesh, India

Site Status

Countries

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India

Central Contacts

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Asir J Samuel, MPT, PhD

Role: CONTACT

+918059930222

Facility Contacts

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Asir J Samuel, MPT, PhD

Role: primary

08059930222

Role: backup

Kiranjeet Kaur, MBBS, MD

Role: primary

Other Identifiers

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MMDU/IEC/141E

Identifier Type: -

Identifier Source: org_study_id

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