Polycystic Ovary SyndromeNCT04335227
Yoga Therapy and Aerobic Exercise on Anti-Mullerian Hormone in Young Women With Polycystic Ovary Syndrome
A study testing Structured yoga therapy program, Aerobic exercise training program and Combined yoga and aerobic training program in people with Polycystic Ovary Syndrome and Anti-Mullerian Hormone Deficiency, run by Maharishi Markendeswar University (Deemed to be University) at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Anti-Mullerian Hormone Deficiency, Female Infertility Endocrine
- What is being tested?
- Structured yoga therapy program, Aerobic exercise training program and Combined yoga and aerobic training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesIndia
- Study dates
- 14 Nov 2021to 14 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
India2 sites
Maharishi Markandeshwar Hospital, Mullana
Ambāla, Haryana, 133207
Asir J Samuel, MPT, PhD, 08059930222, asirjohnsamuel@mmumullana.org
asirjohnsamuel@mmumullana.org
Maharishi Markandeshwar Medical College & Hospital, Kumarhatti
Solan, Himachal Pradesh, 173229
Kiranjeet Kaur, MBBS, MD, principal.mmmch@mmusolan.org
Kiranjeet Kaur, MBBS, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome, Anti-Mullerian Hormone Deficiency, Female Infertility Endocrine
- Being tested
- Structured yoga therapy program, Aerobic exercise training program, Combined yoga and aerobic training program, Nutritional management
- Keywords
- Yoga therapy, Aerobic exercise training, Aerobic exercise, Aerobic training, Polycystic ovary syndrome, Antimullerian hormone
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Combined yoga and aerobic training program |
| Control group | Active comparator | Nutritional management uniquely prepared by dietitian Receives: Other: Nutritional management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Anti-Mullerian hormone Concentration
Serum Anti-Mullerian hormone will be determined by blinded lab technician
Measured: Change from Baseline Serum Anti-Mullerian hormone Concentration at 12 weeks
Secondary outcomes (11)
Antral follicle count
Antral follicle count will be determined by blinded gynaecologist
Measured: 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
Measured: 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
Measured: Change from Baseline Serum Luteinizing hormone Concentration at 12 weeks
Serum Testosterone Concentration
Serum Testosterone will be determined by blinded lab technician
Measured: Change from Baseline Serum Testosterone Concentration at 12 weeks
Serum Prolactin Concentration
Serum Prolactin will be determined by blinded lab technician
Measured: 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
Measured: 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
Measured: Change from Baseline Serum Dehydroepiandrosterone sulfate Concentration at 12 weeks
Serum Insulin fasting Concentration
Serum Insulin fasting will be determined by blinded lab technician
Measured: Change from Baseline Serum Insulin fasting Concentration at 12 weeks
Serum Glucose fasting Concentration
Serum Glucose fasting will be determined by blinded lab technician
Measured: 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
Measured: 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
Measured: Change from Baseline Concentration of Lipid profiles in serum at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start14 Nov 2021 (estimated)
- Primary completion12 Mar 2023 (estimated)
- Study completion14 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Asir J Samuel, MPT, PhD, Principal investigator, Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, MullanaUnmesh Santpur, MBBS, MD, Study director, Maharishi Markandeshwar Institute of Medical Sciences and Research, MullanaKiranjeet Kaur, MBBS, MD, Study chair, Maharishi Markandeshwar Medical College & Hospital, Solan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335227
- Sponsor's protocol ID
- MMDU/IEC/141E
- Status last verified
- Aug 2021
- First submitted
- 27 Mar 2020
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not now
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga Therapy and Aerobic Exercise on Anti-Mullerian Hormone and Other Biochemical Markers in Young Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT04335227
- Acronym / sponsor ID
- MMDU/IEC/141E
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- 14 Nov 2021 (estimated)
- Primary completion
- 12 Mar 2023 (estimated)
- Study completion
- 14 Apr 2023 (estimated)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Yoga therapy group | Experimental | Other: Structured yoga therapy programStructured yoga therapy program for 60 minutes six days per week for 12 weeks and nutritional management uniquely prepared by dietitian |
| Aerobic exercise group | Experimental | Other: Aerobic exercise training programAerobic 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 and aerobic exercise group | Experimental | Other: Combined yoga and aerobic training programCombined yoga therapy for three days and vigorous aerobic exercise program for three days with nutritional management uniquely prepared by dietitian |
| Control group | Active comparator | Other: Nutritional managementNutritional management uniquely prepared by dietitian |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured yoga therapy programStructured 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 | Other | Yoga therapy group |
| Aerobic exercise training programThirty 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 | Other | Aerobic exercise group |
| Combined yoga and aerobic training programThirty 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 | Other | Combined yoga therapy and aerobic exercise group |
| Nutritional managementThirty two females with PCOS will be asked to undergo only nutritional management uniquely prepared by dietitian | Other | Control group |
Primary outcome
Serum Anti-Mullerian hormone Concentration
Time frame: Change from Baseline Serum Anti-Mullerian hormone Concentration at 12 weeks
Serum Anti-Mullerian hormone will be determined by blinded lab technician
11 secondary outcomes
Antral follicle count
Time frame: Change from Baseline Antral follicle count at 12 weeks
Serum Follicle-stimulating hormone Concentration
Time frame: Change from Baseline Serum Follicle-stimulating hormone Concentration at 12 weeks
Serum Luteinizing hormone Concentration
Time frame: Change from Baseline Serum Luteinizing hormone Concentration at 12 weeks
Serum Testosterone Concentration
Time frame: Change from Baseline Serum Testosterone Concentration at 12 weeks
Serum Prolactin Concentration
Time frame: Change from Baseline Serum Prolactin Concentration at 12 weeks
Serum Thyroid-stimulating hormone Concentration
Time frame: Change from Baseline Serum Thyroid-stimulating hormone Concentration at 12 weeks
Serum Dehydroepiandrosterone sulfate Concentration
Time frame: Change from Baseline Serum Dehydroepiandrosterone sulfate Concentration at 12 weeks
Serum Insulin fasting Concentration
Time frame: Change from Baseline Serum Insulin fasting Concentration at 12 weeks
Serum Glucose fasting Concentration
Time frame: Change from Baseline Serum Glucose fasting Concentration at 12 weeks
Homeostatic Model Assessment for Insulin Resistance
Time frame: Change from Baseline Homeostatic Model Assessment for Insulin Resistance at 12 weeks
Concentration of Lipid profiles in serum
Time frame: Change from Baseline Concentration of Lipid profiles in serum at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Individual participant dataSharing planned: No. Not now
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asir J Samuel, MPT, PhD principal investigator
Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, Mullana
Unmesh Santpur, MBBS, MD study director
Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana
Kiranjeet Kaur, MBBS, MD study chair
Maharishi Markandeshwar Medical College & Hospital, Solan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured yoga therapy program, Aerobic exercise training program and Combined yoga and aerobic training program in people with Polycystic Ovary Syndrome and Anti-Mullerian Hormone Deficiency, run by Maharishi Markendeswar University (Deemed to be University) at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asir J Samuel, MPT, PhD (+918059930222, asirjohnsamuel@mmumullana.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Anti-Mullerian hormone Concentration (time frame: Change from Baseline Serum Anti-Mullerian hormone Concentration at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.