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

Completed

Conditions: Postmenopausal women for phase 1 and 2Premenopausal women for phase 1 only

Registration Number: CTRI/2023/10/058517

Lead Sponsor: Chhatrapati Shahu Ji Maharaj University

Brief Summary: Background

Menopause is described as amenorrhea for a year without any underlying pathology. There are physiological changes due to menopause that could contribute directly to limitations in physical function.

Few authors reported that the menopausal status is also associated with low lung function. Maintaining functional status is an imperative part of an active ageing process, as it enables independent living and improves the quality of life. It has been proposed that exercising beyond menopause is the beneficial aspect of lifestyle modification and must be opted by all.

The menopausal process leads to decline in pulmonary and physical function which is essential in maintaining independence in daily life. The lack of independence may have significant public health implications owing to the adverse impact on quality of life of postmenopausal women as they age.

There is evidence regarding evaluation of pulmonary and physical function among postmenopausal women but it is limited. However, there is dearth of literature regarding protocols to improve pulmonary and physical function in postmenopausal women. Thus, there is need to propose a protocol addressing various domains of physical function and pulmonary function to improve health status of postmenopausal women.

Purpose

To measure thew pulmonary function values in premenopausal and postmenopausal women.

To measure thew physical function values in premenopausal and postmenopausal women.

To develop and pilot test the multimodal protocol for pulmonary and physical function among postmenopausal women.

To evaluate the multimodal protocol for pulmonary and physical function among postmenopausal women.

Phases of study

Phase 1

# Evaluation of pulmonary and physical function among postmenopausal and premenopausal women

Sample population: Postmenopausal women and Premenopausal women

Variables: Pulmonary function and physical function

Ã˜ #Development of protocol and pilot testing

Sample population: Postmenopausal women

Procedure Outline

The guidelines by Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare: revised guideline (CReDECI 2) will be used.

Phase 2

Evaluation of Protocol

Sample Population: Postmenopausal women

Sample size: To be calculated based on pilot study

Dependent variable: Pulmonary function and physical function

Independent variable: Multimodal protocol

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 326

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.
Phase 2 The sample population will include postmenopausal women.
The sample size and selection criteria will depend on results of phase 1.

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) â©¾100 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	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.
Physical function assessed by tests of physical performance	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 Outcome Measures

Name	Time	Method
For phase 1 first part the secondary outcome will be	six minute walk work

Trial Locations

Locations (1): Chhatrapati Shahu Ji Maharaj University
🇮🇳
Nagar, UTTAR PRADESH, India
Chhatrapati Shahu Ji Maharaj University
🇮🇳Nagar, UTTAR PRADESH, India
Dr Hina Vaish PT
Principal investigator
9450124758
hinavaish@csjmu.ac.in