| CTRI Number |
CTRI/2023/10/058517 [Registered on: 11/10/2023] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Developing and evaluating role of a protocol with multiple modes for physical and respiratory function among women who have undergone menopause. |
|
Scientific Title of Study
|
Development and Evaluation of a Multimodal Protocol for Pulmonary and Physical Function among Postmenopausal Women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hina Vaish |
| Designation |
PhD Scholar |
| Affiliation |
School of Health Sciences, Chhatrapati Shahu Ji Maharaj University |
| Address |
School of Health Sciences, Chhatrapati Shahu Ji Maharaj University
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
9450124758 |
| Fax |
|
| Email |
hinavaish@csjmu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Hina Vaish |
| Designation |
PhD Scholar |
| Affiliation |
School of Health Sciences, Chhatrapati Shahu Ji Maharaj University |
| Address |
School of Health Sciences, Chhatrapati Shahu Ji Maharaj University
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
9450124758 |
| Fax |
|
| Email |
hinavaish@csjmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DIGVIJAY SHARMA |
| Designation |
Assistant Professor and Director |
| Affiliation |
School of Health Sciences, Chhatrapati Shahu Ji Maharaj University |
| Address |
School of Health Sciences, Chhatrapati Shahu Ji Maharaj University
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
9839217108 |
| Fax |
|
| Email |
digvijaysharma@csjmu.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Chhatrapati Shahu Ji Maharaj University |
| Address |
Chhatrapati Shahu Ji Maharaj University, Kalyanpur, Kanpur, Uttar Pradesh, India 208024 |
| Type of Sponsor |
Other [State University ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hina Vaish PT |
Chhatrapati Shahu Ji Maharaj University |
Physiotherapy OPD, Room No:SHS 106, Chhatrapati Shahu Ji Maharaj University, Kalyanpur
Kanpur Nagar
UTTAR PRADESH |
9450124758
hinavaish@csjmu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chhatrapati Shahu Ji Maharaj Human Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postmenopausal women for phase 1 and 2
Premenopausal women for phase 1 only |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 physical function parameters.
It will be included mutiple modes of exercise for pulmonary and physical function, following the guidelines. The guidelines by Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare: revised guideline (CReDECI 2) will be used. |
| Comparator Agent |
Standard care |
The components of protocol to be given will be based on the results of phase 1 as per the guidelines of Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare: revised guideline (CReDECI 2) for comparator. the characteristics |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Pulmonary function assessed by spirometry
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
|
| Outcome |
TimePoints |
For phase 1 first part the secondary outcome will be
six minute walk work
Percent predicted HR max after six minute walk test etc |
For phase 1, secondary outcomes will be evaluated one time after screening |
|
|
Target Sample Size
|
Total Sample Size="326"
Sample Size from India="326"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/10/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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 Ø #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 |