Skip to content

Developing and evaluating role of a protocol with multiple modes for physical and respiratory function among women who have undergone menopause.

Development and Evaluation of a Multimodal Protocol for Pulmonary and Physical Function among Postmenopausal Women - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/058517
Enrollment
326
Registered
2023-10-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Multimodal protocol: Multimodal protocol will be developed and evaluated based on the results of phase 1. The multimodal protocol will be based for the enhancing the pulmonary and phys

Sponsors

Chhatrapati Shahu Ji Maharaj University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Pulmonary function assessed by spirometry Physical function assessed by tests of physical performance Timepoint: Phase 1 Physical function and pulmonary function will be assessed after screening for first part of phase 1. Phase 1 Second part The pulmonary and physical function will be assessed at baseline of pilot study and then after intervention as per protocol developed. Phase 2 The pulmonary and physical function will be assessed at baseline and after intervention as per the results of phase 1.

Secondary

MeasureTime frame
For phase 1 first part the secondary outcome will be six minute walk work Percent predicted HR max after six minute walk test etcTimepoint: For phase 1, secondary outcomes will be evaluated one time after screening

Countries

India

Contacts

Public ContactDIGVIJAY SHARMA

School of Health Sciences, Chhatrapati Shahu Ji Maharaj University

hinavaish@csjmu.ac.in9450124758

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026