Developing and evaluating role of a protocol with multiple modes for physical and respiratory function among women who have undergone menopause.
- Registration Number
- CTRI/2023/10/058517
- Lead Sponsor
- Chhatrapati Shahu Ji Maharaj University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Phase 1
First part
The participants will be included if they will be
Women aged 40 to 55 years will be recruited and depending on the menstrual history participants will be classified as premenopausal and postmenopausal. Menstrual bleeding pattern will be classified based on series of questions.
Asymptomatic women with stable vitals
Body mass index of 18-5 to 29.9 kg/m2
Absence of any acute disease in the 6 weeks preceding the study.
Phase 1
Second Part
Development of multimodal protocol and its pilot testing
The sample population will include postmenopausal women.
The sample size and selection criteria will depend on preliminary findings.
Phase 2
The sample population will include postmenopausal women.
The sample size and selection criteria will depend on results of phase 1.
Phase 1
First part
Any documented health problem or use of medication that might interfere with the ability to perform physical exercises (such as impaired cognition, and metabolic, cardiac, neuromuscular or musculoskeletal disease).
Use of walking aids
Resting blood pressure >139/89 mmHg,
Resting heart rate (HR) ?100 beats per min.
Peri-menopausal women with or without use of hormone
Phase 1
Second Part
Development of multimodal protocol and its pilot testing
The sample size and selection criteria will depend on preliminary findings.
Phase 2
The sample size and selection criteria will depend on results of phase 1.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pulmonary function assessed by spirometry <br/ ><br> <br/ ><br>Physical function assessed by tests of physical performance <br/ ><br>Timepoint: Phase 1 <br/ ><br>Physical function and pulmonary function will be assessed after screening for first part of phase 1. <br/ ><br> <br/ ><br>Phase 1 <br/ ><br>Second part <br/ ><br>The pulmonary and physical function will be assessed at baseline of pilot study and then after intervention as per protocol developed. <br/ ><br> <br/ ><br>Phase 2 <br/ ><br>The pulmonary and physical function will be assessed at baseline and after intervention as per the results of phase 1.
- Secondary Outcome Measures
Name Time Method For phase 1 first part the secondary outcome will be <br/ ><br>six minute walk work <br/ ><br>Percent predicted HR max after six minute walk test etcTimepoint: For phase 1, secondary outcomes will be evaluated one time after screening