Effect of Yoga on Physical and emotional health of infertile women with Polycystic Ovary Syndrome(PCOS)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Outcome measures will be pre and post intervention change in psychological status assessed by emotional health scales, physical status assessed by Body mass composition, BMI, waist hip ratio at the end of 12 weeks of Yoga intervention.
研究概览
简要总结
Introduction:
Polycystic ovarian syndrome (PCOS) is the most prevalent female endocrine disorder with estimates ranging from 2.2% to as high as 26%. More than 50% of women with PCOS are obese and need lifestyle interventions. Studies prove that PCOS women show high prevalence of anxiety, depressive disorders and suicide attempts. Also women with PCOS suffering from infertility are under tremendous psychological stress which has a vicious effect on the treatment results as well.
Rationale:
Yoga therapy mainly improves reproductive functions by reducing stress and balancing the neurohormonal profile. To the best of our knowledge there are no published research studies on the effect of Yoga on physical and emotional well being among infertile women with PCOS.
Study designHence we wish to undertake this prospective intervention study to understand the effect of Yoga on physical and emotional well being of infertile women with Polycystic Ovary Syndrome (PCOS) with following
Objectives:
- To implement yoga as an integral component in our multidisciplinary approach among infertile women with PCOS.
- To study the effect of guided Yoga intervention on physical and emotional well being of infertile women with PCOS.
- To understand the acceptability, barriers and facilitating factors for introducing Yoga intervention in this group.
Methodology:
This will be a Joint collaboration between NIRRH and Kaivalyadham Institute of Yoga.
140 Infertile women with PCOS from NIRRH PCOS clinic will be recruited for the study (70 intervention group and 70 control).Pre and Post Estimation of following parameters will be done as mentioned below.
Emotional well being: PCOS-Q, Anxiety Depression scales, Body image issues, eating habits, sleep pattern
Clinical(height, weight, BMI, Waist-hip ratio, B. P, FG score, acne, acanthosis nigricans)
Ultrasound pelvis and abdomen (for PCOS, Non alcoholic Fatty Liver and cholelithiasis)
Hormonal tests (TSH, Prolactin, LH, FSH, testosterone, SHBG, 17-OHP, Vitamin D, s.AMH s.Cortisol)
Metabolic tests (75g OGTT, Insulin, Lipid profile)
Specific Yoga module for women with PCOS will be prepared. Yoga Intervention will be given thrice a week for 12 weeks.
Outcome in terms of pre and post intervention improvement in emotional well being, improvement in physical, endocrine, biochemical parameters, ovulation at end of 12 weeks will be assessed.
Utilisation of outcome
Findings from this study will be used to plan future implementation research to upscale Yoga intervention among infertile women with PCOS across India through medical colleges of NIRRH field units in collaboration with Kaivalyadham and AYUSH.
Key words: PCOS, Infertile women, Yoga
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Infertile women with PCOS(Age 18 – 45 years) 2.Not on medication like oral contraceptive pills, metformin at time of baseline investigation 3.Willing to participate in the study.
- •4.Assuring to comply with the 12 week intervention.
排除标准
- •1.Not willing to participate in study.
结局指标
主要结局
Outcome measures will be pre and post intervention change in psychological status assessed by emotional health scales, physical status assessed by Body mass composition, BMI, waist hip ratio at the end of 12 weeks of Yoga intervention.
时间窗: At the end of 12 weeks
次要结局
- Ovulation, endocrine and metabolic status assessed by hormonal and biochemical parameters at the end of 12 weeks of Yoga intervention(At the end of 12 weeks)