Effectiveness of a culturally appropriate integrated education and exercise intervention to improve quality of life among peri and postmenopausal women in Chandigarh: A randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- Mean change in Menopause specific quality of life total scores from baseline to post intervention in both intervention and control group.
研究概览
简要总结
Recruitment of 266 eligible participants that is perimenopausal and postmenopausal women aged 40-65 years residing in the field practice area will be done by the principal investigator with the help of staff from Health and Wellness Centre, Sector -49. Informed consent and ethical considerations will be undertaken throughout the study.A computer-generated randomized sequence will be created using a randomization software. This sequence will be used to allocate them to either the intervention or control group. This sequence will be generated by an independent researcher not directly involved in the recruitment or implementation of intervention.The allocation sequence will be concealed until the participants are recruited and their baseline assessments are completed. Allocation concealment will be ensured to prevent selection bias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Peri and post-menopausal women of age group (40-65 years)
- •Resident of the study area in Chandigarh.
- •Participants who will give written informed consent.
- •Participants who have WhatsApp in there phone.
排除标准
- •Women who do not fall in the defined age group.
- •Women with a known history of chronic illness- Uncontrolled hypertension, uncontrolled diabetes mellitus, unstable cardiovascular disease, recent fracture or surgeries, severe osteoarthritis, neurological disorder affecting motor function and use of hormone replacement therapy.
结局指标
主要结局
Mean change in Menopause specific quality of life total scores from baseline to post intervention in both intervention and control group.
时间窗: Base line assessment(t0) | Immediate endline assessment postintervention(t1)
次要结局
- 1. Change in proportion of women having Menopausal symptoms(2. Mean change in weight, waist circumference, waist hip ratio among the participants before and after the intervention.)
研究者
Dr Priyanka Negi
Postgraduate Institute of Medical Education and Research