Assessing the impact of Menopause care bundle on health related quality of life in Perimenopausal Women : A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The outcome will be measured by Comparing MENQOL scores in both groups after the 12th week of intervention
研究概览
简要总结
This study is a randomised, parallel group interventional trial assessing the effectiveness of a comprehensive lifestyle modification strategy, implemented through a bundle-of-care approach, in improving the menopause-related quality of life, cardiometabolic health, and genitourinary well-being of perimenopausal women. The study will target perimenopausal women, typically aged 40-50 years, who are experiencing the transitional phase of menopause and facing associated health challenges. The intervention group will receive menopause care as a bundle of care approach and will be reassessed at 12 weeks of intervention. The Bundle of Care approach will involve integrated lifestyle modifications, including Dietary changes aimed at promoting overall health and addressing specific risks related to perimenopause, physical activity interventions focused on exercise routines that improve cardiovascular, metabolic, and musculoskeletal health, stress management techniques such as mindfulness, relaxation practices through health education to address emotional well-being. These interventions will be designed to be sustainable and feasible for long-term implementation in daily life and menopause-related quality of life. The control group will receive routine symptomatic care as per standard. The impact of lifestyle modifications will be assessed using the MENQOL scoring system at 12 weeks. In secondary outcomes, the research will focus on the changes in cardiometabolic markers such as blood pressure, body mass index (BMI), lipid profile (cholesterol levels), glucose metabolism, and genitourinary health in terms of improvement in urinary symptoms, vaginal health, and sexual function at 12 weeks of intervention. This research aims to fill a gap in understanding how a comprehensive, bundled lifestyle modification strategy can address the diverse health challenges faced by perimenopausal women and contribute to better long-term health outcomes. These interventions can be an integral part of geriatric healthcare practices for the healthy ageing of women.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women (in the age group 40-50 years) with Perimenopausal symptoms who have given consent for participation and have not received HRT in the last three months before the study.
排除标准
- •The patient who has received HRT within the last 3 months.
- •A woman who has received HRT within the last 3 months, A diagnosed case of atherosclerotic cardiovascular disease and psychiatric illness, and on treatment.
- •Iatrogenic menopausal status.
- •A patient who has undergone any pelvic floor surgery.
- •Refusal of consent.
结局指标
主要结局
The outcome will be measured by Comparing MENQOL scores in both groups after the 12th week of intervention
时间窗: 12 weeks
次要结局
- BCA, body fat percentage, and echocardiographic changes to assess cardiometabolic health and comparison of pelvic floor muscle strength by measuring the modified Oxford scale score in both groups(12 weeks)
研究者
Urmila Sunda
AIIMS ,Rajkot