Impact of Electrical Muscle Stimulation on Metabolic, Somatic, and Psychosocial Health in Polycystic Ovary Syndrome Patients: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Insulin Resistance Menstrual health Glucose metabolism Plasma Glucose level Hyperandrogenism quality of life
研究概览
简要总结
Polycystic Ovary Syndrome PCOS is a common endocrine disorder in women of reproductive age associated with metabolic, somatic and psychological complications. Current treatments rely on lifestyle changes and medications but often face adherence challenges. Electrical Muscle Stimulation EMS is a non invasive method that mimics exercise by inducing muscle contractions and may improve insulin sensitivity, metabolic health, body composition and quality of life. This randomized controlled trial aims to evaluate the effects of a 12 week EMS program on metabolic parameters glucose, insulin resistance, lipid profile, blood pressure, testosterone, somatic outcomes body weight, BMI, waist to hip ratio, body composition and psychosocial health quality of life, mood, anxiety and menstrual well being in women with PCOS. The study seeks to provide evidence for EMS as a novel adjunct therapy for improving health outcomes and quality of life in PCOS patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Medically diagnosed and according to Rotterdam criteria (at least two of the following oligo/anovulation, clinical and/or biochemical signs of hyperandrogenism, polycystic ovaries)BMI more than 24 kg/m² (Sam S.
- •Obesity and Polycystic Ovary Syndrome.
- •Obes Manag.
- •2007 Apr;3(2):69-
- •doi: 10.1089/obe.2007.
- •PMID: 20436797; PMCID:PMC2861983) Willing to provide informed consent and comply with study protocol.
排除标准
- •Use of hormonal medications like oral contraceptives within the last 3 months Pregnant or planning to become pregnant within the study period Any neurological disorders like multiple sclerosis amyotrophic lateral sclerosis Guillain Barre syndrome etc Any systemic disease like liver dysfunction IBD Kidney failure etc Any congenital disorders like Turner Syndrome Congenital Adrenal Hyperplasia Marfan syndrome History of Cancer Diagnosed with other endocrine disorders like thyroid dysfunction Cushing syndrome etc History of any cardiovascular diseases like uncontrolled hypertension unstable angina etc Participation in another clinical trial at present and within the last six months.
结局指标
主要结局
Insulin Resistance Menstrual health Glucose metabolism Plasma Glucose level Hyperandrogenism quality of life
时间窗: base line 12 weeks and follow up 3 months
次要结局
- BMI , Body composition analysis , hip to waist ratio(base line 12 weeks and follow up 3 months)
研究者
Divya Goyal
Department of physiotherapy , School of healthcare and allied sciences ,GD Goenka University