跳至主要内容
临床试验/CTRI/2025/04/085069
CTRI/2025/04/085069尚未招募不适用

Association between energy expenditure, physical activity and body composition among polycystic ovarian syndrome (PCOS) and healthy young women

Vijayshree S V1 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2025年4月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
214
试验地点
1
主要终点
PCOS is confirmed through Clinical Tool for diagnosis of PCOS

研究概览

简要总结

The study aims to assess the association between energy expenditure, physical activity, and body composition in self-reported clinically diagnosed PCOS patients and healthy young women. This cross-sectional research, conducted after Institutional Ethical Clearance, will categorize participants into two groups: Group A (PCOS) and Group B (healthy controls) based on a self-administered Clinical Tool for Diagnosis of PCOS. Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ), while body composition will be analyzed with a body fat analyzer assessing BMI, fat percentage, muscle mass, and other parameters. Energy expenditure will be evaluated using the Timed 10-Meter Walk Test, where heart rate and walking speed will determine the Physiological Cost Index (PCI). The study aims to identify the association  between these variables in both groups, providing insights into the physiological impact of PCOS. Statistical analysis will follow to interpret the findings.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 26.00 Year(s)(—)
性别
Female

入选标准

  • Young women of age group 18 to 26 years •Nulliparous women •BMI Underweight and normal 18.5 to 22.9 kg per m2 Overweight and obese 23.0 to 30.0 kgm2 GROUP A Subjects with PCOS •Self reported clinically diagnosed PCOS •PCOS confirmed by Clinical tool for diagnosis of PCOS of score greater than or equal to 2 GROUP B Subjects without PCOS •Healthy young women •Subjects with regular menstrual cycle •Subjects without PCOS is confirmed by Clinical tool for diagnosis of PCOS of score less than 2.

排除标准

  • •Subjects with cardiovascular disease, pulmonary, liver or renal disease, neuromuscular disease and musculoskeletal disorders.
  • •Subjects with known case of chronic medical conditions, systemic diseases or metabolic diseases such as diabetes mellitus, hypertension, thyroid and under medications.
  • •Subjects currently under menstruation phase and with associated illness.
  • •Subjects not willing to participate.

结局指标

主要结局

PCOS is confirmed through Clinical Tool for diagnosis of PCOS

时间窗: 5 months

Energy expenditure will be assessed through Physiological Cost Index PCI= (Working HR-Rest HR)/Walking Speed

时间窗: 5 months

Physical Activity will be assessed through International Physical Activity Questionnaire (IPAQ)

时间窗: 5 months

Body Coposition will be assessed through Body Fat Analyser

时间窗: 5 months

次要结局

  • Other variables such as height, weight, BMI(5 months)

研究者

发起方
Vijayshree S V
申办方类型
Other [Self funding]

研究点 (1)

Loading locations...

相似试验