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临床试验/NCT05577949
NCT05577949招募中不适用

The Effect of Structured Aerobics Exercise Programme for the Improvement of Mental and Physical Health Parameters in Patients With Polycystic Ovary Syndrome: A Randomised Controlled Trial

Muhammad Irfan4 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
176
试验地点
4
主要终点
PCOS Quality of Life scale

研究概览

简要总结

Polycystic ovary is one of the most common metabolic and endocrine disorders in women of reproductive age group. The Rotterdam criteria are used internationally for its diagnosis. It has been reported that 57% of these women have at least one mental disorder. There is no health without mental health and it is fundamental to the good health and well-being of an individual. Women with PCOS are at risk of a wide range of significant psychological difficulties including depression, anxiety, eating disorders, sexual disorders, low self-esteem, poor body image, and overall low quality of life. In the healthy population, exercise plays a pivotal role in the optimization of mental health, but there is little evidence available to demonstrate its effects on women with PCOS. So, this study has been designed to study the effects of structured aerobics exercise programs on the mental and physical health of women with PCOS.

详细描述

Polycystic ovary syndrome is also referred to as "Hyperandrogenic anovulation or Stein Levinthal Syndrome". It has affected approximately 10 % of women of childbearing age. The prevalence of PCOS is higher among Pakistani women i.e. 52% as compared to the UK. The Rotterdam criteria are internationally used for the diagnosis of PCOS, which requires two out of the three features: signs of hyperandrogenism, ovulatory dysfunction, and ultrasound features of PCOS.

Although physical symptoms are increasingly recognized in women with PCOS, little attention has been paid to the mental health and well-being of these patients. PCOS creates an important psychological burden throughout the lifetime of these women. 57% of women with polycystic ovary syndrome have at least one mental disorder. Also, mental health is an essential part of public health and it is one of the most important indicators of the quality of health care in society.

Women with PCOS are at risk of a wide range of significant psychological difficulties including depression, anxiety, eating disorders, sexual disorders, low self-esteem, poor body image, and overall a lowered quality of life. In a healthy population, lifestyle modifications, particularly physical activity, and exercise play a pivotal role in the optimization of mental health but there is little evidence available to demonstrate the effects of exercise on the optimization of psychological well-being and physical health of women with PCOS. So, this study has been designed to study the effect of a structured aerobics exercise program on the mental and physical health of women with PCOS.

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)

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All women diagnosed with PCOS according to the Rotterdam criteria with the age range of 18-49 years

排除标准

  • Women that do not own personal smartphones
  • Patients with endocrinological diseases like diabetes mellitus
  • Thyroid, adrenal, or pituitary dysfunction
  • Hepatic and pulmonary diseases
  • Other diseases which can limit their physical activity or make it hazardous for them
  • Participants with significant cognitive impairment, like intellectual disability or dementia, or active psychosis.

结局指标

主要结局

PCOS Quality of Life scale

时间窗: 12 weeks (3 months)

Change in the score of the PCO quality of life scale from baseline to midway to end of therapy, higher scores mean a better quality of life.

Hospital Anxiety and Depression Scale

时间窗: 12 weeks (3 months)

Change in the score of the Hospital anxiety and depression scale from baseline to midway to end of therapy, 0-7 indicates normal, 8 to 10 indicates borderline and 11-21 indicates abnormal cases. Higher scores mean a worse outcome

次要结局

  • ENRICH marital satisfaction scale(12 weeks (3 months))

研究者

发起方
Muhammad Irfan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Muhammad Irfan

Professor & Head, Department of Mental Health, Psychiatry and Behavioural Sciences

Peshawar Medical College

研究点 (4)

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