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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04335227
• Other study ID #: MMDU/IEC/141E
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 14, 2021
• Est. completion date: April 14, 2023

Study information

• Verified date: August 2021
• Source: Maharishi Markendeswar University (Deemed to be University)
• Contact: Asir J Samuel, MPT, PhD
• Phone: +918059930222
• Email: asirjohnsamuel[@]mmumullana.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: April 14, 2023
• Est. primary completion date: March 12, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
India	Maharishi Markandeshwar Hospital, Mullana	Ambala	Haryana
India	Maharishi Markandeshwar Medical College & Hospital, Kumarhatti	Solan	Himachal Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Maharishi Markendeswar University (Deemed to be University)

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Antral follicle count	Antral follicle count will be determined by blinded gynaecologist	Change from Baseline Antral follicle count at 12 weeks
Secondary	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
Secondary	Serum Luteinizing hormone Concentration	Serum Luteinizing hormone will be determined by blinded lab technician	Change from Baseline Serum Luteinizing hormone Concentration at 12 weeks
Secondary	Serum Testosterone Concentration	Serum Testosterone will be determined by blinded lab technician	Change from Baseline Serum Testosterone Concentration at 12 weeks
Secondary	Serum Prolactin Concentration	Serum Prolactin will be determined by blinded lab technician	Change from Baseline Serum Prolactin Concentration at 12 weeks
Secondary	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
Secondary	Serum Dehydroepiandrosterone sulfate Concentration	Serum Dehydroepiandrosterone sulfate will be determined by blinded lab technician	Change from Baseline Serum Dehydroepiandrosterone sulfate Concentration at 12 weeks
Secondary	Serum Insulin fasting Concentration	Serum Insulin fasting will be determined by blinded lab technician	Change from Baseline Serum Insulin fasting Concentration at 12 weeks
Secondary	Serum Glucose fasting Concentration	Serum Glucose fasting will be determined by blinded lab technician	Change from Baseline Serum Glucose fasting Concentration at 12 weeks
Secondary	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
Secondary	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