Yoga Therapy and Aerobic Exercise on Anti-Mullerian Hormone and Other Biochemical Markers in Young Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 128
- 试验地点
- 4
- 主要终点
- Serum Anti-Mullerian hormone Concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Lab technician who test the blood samples of the female with Polycystic Ovary Syndrome (PCOS) will be blinded to the trial
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Serum Anti-Mullerian hormone Concentration
时间窗: Change from Baseline Serum Anti-Mullerian hormone Concentration at 12 weeks
Serum Anti-Mullerian hormone will be determined by blinded lab technician
次要结局
- Antral follicle count(Change from Baseline Antral follicle count at 12 weeks)
- Serum Luteinizing hormone Concentration(Change from Baseline Serum Luteinizing hormone Concentration at 12 weeks)
- Concentration of Lipid profiles in serum(Change from Baseline Concentration of Lipid profiles in serum at 12 weeks)
- Serum Glucose fasting Concentration(Change from Baseline Serum Glucose fasting Concentration at 12 weeks)
- Homeostatic Model Assessment for Insulin Resistance(Change from Baseline Homeostatic Model Assessment for Insulin Resistance at 12 weeks)
- Serum Follicle-stimulating hormone Concentration(Change from Baseline Serum Follicle-stimulating 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)
- Serum Thyroid-stimulating hormone Concentration(Change from Baseline Serum Thyroid-stimulating hormone Concentration at 12 weeks)
- Serum Dehydroepiandrosterone sulfate Concentration(Change from Baseline Serum Dehydroepiandrosterone sulfate Concentration at 12 weeks)
- Serum Insulin fasting Concentration(Change from Baseline Serum Insulin fasting Concentration at 12 weeks)
研究者
Asir John Samuel
Associate Professor
Maharishi Markendeswar University (Deemed to be University)