search
Back to results

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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Structured yoga therapy program
Aerobic exercise training program
Combined yoga and aerobic training program
Nutritional management
Sponsored by
Maharishi Markendeswar University (Deemed to be University)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Yoga therapy, Aerobic exercise training, Aerobic exercise, Aerobic training, Polycystic ovary syndrome, Antimullerian hormone

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Maharishi Markandeshwar Hospital, Mullana
  • Maharishi Markandeshwar Medical College & Hospital, Kumarhatti

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Yoga therapy group

Aerobic exercise group

Combined yoga therapy and aerobic exercise group

Control group

Arm Description

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

Aerobic training of moderate intensity for 30-60 minutes six days per week for 12 weeks and nutritional management uniquely prepared by dietitian

Combined yoga therapy for three days and vigorous aerobic exercise program for three days with nutritional management uniquely prepared by dietitian

Nutritional management uniquely prepared by dietitian

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Antral follicle count
Antral follicle count will be determined by blinded gynaecologist
Serum Follicle-stimulating hormone Concentration
Serum Follicle-stimulating hormone will be determined by blinded lab technician
Serum Luteinizing hormone Concentration
Serum Luteinizing hormone will be determined by blinded lab technician
Serum Testosterone Concentration
Serum Testosterone will be determined by blinded lab technician
Serum Prolactin Concentration
Serum Prolactin will be determined by blinded lab technician
Serum Thyroid-stimulating hormone Concentration
Serum Thyroid-stimulating hormone will be determined by blinded lab technician
Serum Dehydroepiandrosterone sulfate Concentration
Serum Dehydroepiandrosterone sulfate will be determined by blinded lab technician
Serum Insulin fasting Concentration
Serum Insulin fasting will be determined by blinded lab technician
Serum Glucose fasting Concentration
Serum Glucose fasting will be determined by blinded lab technician
Homeostatic Model Assessment for Insulin Resistance
Homeostatic Model Assessment for Insulin Resistance will be determined by blinded lab technician
Concentration of Lipid profiles in serum
Serum total cholesterol, Serum High-density lipoprotein cholesterol, Serum Low-density lipoprotein cholesterol and serum triglycerides

Full Information

First Posted
March 27, 2020
Last Updated
August 22, 2021
Sponsor
Maharishi Markendeswar University (Deemed to be University)
search

1. Study Identification

Unique Protocol Identification Number
NCT04335227
Brief Title
Yoga Therapy and Aerobic Exercise on Anti-Mullerian Hormone in Young Women With Polycystic Ovary Syndrome
Official Title
Yoga Therapy and Aerobic Exercise on Anti-Mullerian Hormone and Other Biochemical Markers in Young Women With Polycystic Ovary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 14, 2021 (Anticipated)
Primary Completion Date
March 12, 2023 (Anticipated)
Study Completion Date
April 14, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maharishi Markendeswar University (Deemed to be University)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Lab technician who test the blood samples of the female with Polycystic Ovary Syndrome (PCOS) will be blinded to the trial
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yoga therapy group
Arm Type
Experimental
Arm Description
Structured yoga therapy program for 60 minutes six days per week for 12 weeks and nutritional management uniquely prepared by dietitian
Arm Title
Aerobic exercise group
Arm Type
Experimental
Arm Description
Aerobic training of moderate intensity for 30-60 minutes six days per week for 12 weeks and nutritional management uniquely prepared by dietitian
Arm Title
Combined yoga therapy and aerobic exercise group
Arm Type
Experimental
Arm Description
Combined yoga therapy for three days and vigorous aerobic exercise program for three days with nutritional management uniquely prepared by dietitian
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Nutritional management uniquely prepared by dietitian
Intervention Type
Other
Intervention Name(s)
Structured yoga therapy program
Intervention Description
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
Intervention Name(s)
Aerobic exercise training program
Intervention Description
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
Intervention Name(s)
Combined yoga and aerobic training program
Intervention Description
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
Intervention Name(s)
Nutritional management
Intervention Description
Thirty two females with PCOS will be asked to undergo only nutritional management uniquely prepared by dietitian
Primary Outcome Measure Information:
Title
Serum Anti-Mullerian hormone Concentration
Description
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 Outcome Measure Information:
Title
Antral follicle count
Description
Antral follicle count will be determined by blinded gynaecologist
Time Frame
Change from Baseline Antral follicle count at 12 weeks
Title
Serum Follicle-stimulating hormone Concentration
Description
Serum Follicle-stimulating hormone will be determined by blinded lab technician
Time Frame
Change from Baseline Serum Follicle-stimulating hormone Concentration at 12 weeks
Title
Serum Luteinizing hormone Concentration
Description
Serum Luteinizing hormone will be determined by blinded lab technician
Time Frame
Change from Baseline Serum Luteinizing hormone Concentration at 12 weeks
Title
Serum Testosterone Concentration
Description
Serum Testosterone will be determined by blinded lab technician
Time Frame
Change from Baseline Serum Testosterone Concentration at 12 weeks
Title
Serum Prolactin Concentration
Description
Serum Prolactin will be determined by blinded lab technician
Time Frame
Change from Baseline Serum Prolactin Concentration at 12 weeks
Title
Serum Thyroid-stimulating hormone Concentration
Description
Serum Thyroid-stimulating hormone will be determined by blinded lab technician
Time Frame
Change from Baseline Serum Thyroid-stimulating hormone Concentration at 12 weeks
Title
Serum Dehydroepiandrosterone sulfate Concentration
Description
Serum Dehydroepiandrosterone sulfate will be determined by blinded lab technician
Time Frame
Change from Baseline Serum Dehydroepiandrosterone sulfate Concentration at 12 weeks
Title
Serum Insulin fasting Concentration
Description
Serum Insulin fasting will be determined by blinded lab technician
Time Frame
Change from Baseline Serum Insulin fasting Concentration at 12 weeks
Title
Serum Glucose fasting Concentration
Description
Serum Glucose fasting will be determined by blinded lab technician
Time Frame
Change from Baseline Serum Glucose fasting Concentration at 12 weeks
Title
Homeostatic Model Assessment for Insulin Resistance
Description
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
Title
Concentration of Lipid profiles in serum
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female with polycystic ovarian syndrome
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asir J Samuel, MPT, PhD
Phone
+918059930222
Email
asirjohnsamuel@mmumullana.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asir J Samuel, MPT, PhD
Organizational Affiliation
Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, Mullana
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Unmesh Santpur, MBBS, MD
Organizational Affiliation
Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kiranjeet Kaur, MBBS, MD
Organizational Affiliation
Maharishi Markandeshwar Medical College & Hospital, Solan
Official's Role
Study Chair
Facility Information:
Facility Name
Maharishi Markandeshwar Hospital, Mullana
City
Ambala
State/Province
Haryana
ZIP/Postal Code
133207
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asir J Samuel, MPT, PhD
Phone
08059930222
Email
asirjohnsamuel@mmumullana.org
Ext
Samuel
Email
asirjohnsamuel@mmumullana.org
First Name & Middle Initial & Last Name & Degree
Asir J Samuel, MPT, PhD
First Name & Middle Initial & Last Name & Degree
Unmesh Santpur, MBBS, MD
Facility Name
Maharishi Markandeshwar Medical College & Hospital, Kumarhatti
City
Solan
State/Province
Himachal Pradesh
ZIP/Postal Code
173229
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiranjeet Kaur, MBBS, MD
Email
principal.mmmch@mmusolan.org
First Name & Middle Initial & Last Name & Degree
Kiranjeet Kaur, MBBS, MD
First Name & Middle Initial & Last Name & Degree
Asir J Samuel, MPT, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not now

Learn more about this trial

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

We'll reach out to this number within 24 hrs