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临床试验/CTRI/2024/08/071815
CTRI/2024/08/071815已完成不适用

Effects of an Individualized Exercise Program on Body composition, Lipid Profile, Mental Health and Ovarian cysts in Young Women with Polycystic Ovarian Syndrome.

Dr Jeslin G N1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2024年8月12日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
162
试验地点
1
主要终点
Transabdominal Ultrasonography

研究概览

简要总结

PCOS has grown to be common affecting the physical and mental well being of Young Women. This situation has sparked intense research on the addition of exercise regimens as part of lifestyle changes/ non pharmacological strategies of management. This study focuses on providing evidence based insights on deciding the best custom made exercise regime to manage the physical, psychological and metabolic disruptions. This study has planned to recruit 162 participants who will be grouped as three: Aerobic and Resistance Training Group, Aerobic Training Group and Control Group with 54 participants in each group. The interventions will be given for 9 weeks prior and after which the outcomes to assess Physical, Psychological and Metabolic parameters.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 25.00 Year(s)(—)
性别
Female

入选标准

  • Young Women diagnosed with PCOS based on Rotterdam Criteria BMI more than 25 Young Women with Low risk according to the ACSM Risk Stratification Guidelines Young Women with PCOS cleared for physical activity as per 2023 Physical Activity Readiness.
  • Questionnaire (PAR-Q+) Young Women willing to comply with the study protocols and attend scheduled assessments.

排除标准

  • Pregnant Women Classic Non cystic Phenotype of PCOS as per the Rotterdam Criteria Untreated Hypothyroidism Inflammatory Arthritis or any lower limb pathology which precludes exercise History of Cardiopulmonary disorders History of receiving more than 6 ovulation cycles with letrozole History of Bariatric surgery History of Renal Disorders History of Liver Disorders Abnormal as per Hospital Anxiety and Depression Scale (HADS) Habitual Smokers & Alcohol Consumers.

结局指标

主要结局

Transabdominal Ultrasonography

时间窗: Baseline to 9 Weeks of Post-Intervention

Lipid Profile

时间窗: Baseline to 9 Weeks of Post-Intervention

Body Composition (BMI, Waist Circumference, Hip Circumference, Waist Hip Ratio, Body fat Percentage)

时间窗: Baseline to 9 Weeks of Post-Intervention

次要结局

  • Hospital Anxiety and Depression Scale (HADS)(Baseline to 9 Weeks of Post-Intervention)

研究者

发起方
Dr Jeslin G N
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Jeslin G N

Saveetha College of Physiotherapy

研究点 (1)

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