| CTRI Number |
CTRI/2025/02/080337 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
6 minute walk test and quality of life in Postmenopausal women. |
|
Scientific Title of Study
|
Association of Functional Capacity with Quality of Life 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 |
km Priyanka Gautam |
| Designation |
MPT student |
| Affiliation |
Chhatrapati Shahu Ji Maharaj University, Kanpur |
| Address |
Physiotherapy OPD room no SHS-106, Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur, Uttar Pradesh.
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
6398096078 |
| Fax |
|
| Email |
gtmpriyanka2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
km Priyanka Gautam |
| Designation |
MPT student |
| Affiliation |
Chhatrapati Shahu Ji Maharaj University, Kanpur |
| Address |
Physiotherapy OPD room no SHS-106, Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur, Uttar Pradesh.
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
6398096078 |
| Fax |
|
| Email |
gtmpriyanka2001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hina Vaish |
| Designation |
Assistant Professor |
| Affiliation |
Chhatrapati Shahu Ji Maharaj University, Kanpur, Uttar Pradesh |
| Address |
SHS-126, Department of Physiotherapy, School of Health Science, Chhatrapati Shahu Ji Maharaj University, Kanpur, Uttar Pradesh.
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
9450124758 |
| Fax |
|
| Email |
hinavaish@csjmu.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur. |
|
|
Primary Sponsor
|
| Name |
Km. Priyanka Gautam |
| Address |
Physiotherapy OPD Room no SHS-106, Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur,Uttar Pradesh. |
| Type of Sponsor |
Other [Self-funded] |
|
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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 |
Chhatrapati Shahu Ji Maharaj University |
Physiotherapy OPD Room no SHS-106, Department of Physiotherapy, School of health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur, Uttar Pradesh.
Kanpur Nagar
UTTAR PRADESH |
9450124758
hinavaish@csjmu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethical Committee, Chhatrapati Shahu Ji Maharaj University, Kanpur, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postmenopausal women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Postmenopausal women; with absence of menstruation from last 1 year and their menopausal status will be confirmed by asking series of questions, Age 40-60 years, Absence of any acute disease in 6 weeks preceding the study, Body Mass Index 18.5-24.9kg/m2 |
|
| ExclusionCriteria |
| Details |
Any use of medications or documented conditions that may affect the study outcomes such as cardiovascular, musculoskeletal, neurological, metabolic or impaired sensation. participants with Systolic blood pressure less than 100mmHg and greater than 139mmHg and diastolic blood pressure less than 60mmHg and greater than 89mmHg, resting heart rate less than 60bpm and greater than 99bpm and participants who are unable to follow commands, Smoker, History of COVID-19, Recent pregnancy in last 2 years, History of any major surgery in last 2 year, Any history of trauma in last 1 year, Women involved in any kind of regular exercise |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| 6-Minute Walk test, Menopause-specific quality of life questionnaire (MENQOL), World Health Organization quality of life-BREF questionnaire (WHOQOL-BREF) |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rate of Perceived Exertion |
This is a one this study so we have collect the data on baseline. |
|
|
Target Sample Size
|
Total Sample Size="137"
Sample Size from India="137"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
SUMMARY Background- All women experience a non-pathologic condition known as menopause. Postmenopausal women suffer from various physical, vasomotor and psychiatric problems due to hormonal changes. Loss of functional capacity (FC) is a common feature of aging in postmenopausal women. There are researches which shows there is decline in FC among postmenopausal women. Among all the method of functional capacity evaluation, 6-minute walk test is used widely due to its simplicity and easy to use. Menopausal symptoms have a significant impact on quality of life (QoL) of postmenopausal women. Factors such as severity of menopausal symptoms, duration negatively affect QoL. There are evidences which shows negative relation between QoL and menopausal symptoms. Decrease in QoL also associated with lower values in physical component in older adults. Need of the Study-There are researches which shows decline in FC and QoL among postmenopausal women. There is evidence that FC is associated with QoL among older adults. To the best of our knowledge no study has evaluated relationship between FC and QoL among postmenopausal women. Menopause-specific quality of life questionnaire (MENQOL) is a reliable tool to measure the influence of menopausal symptoms on QoL among postmenopausal women but is unavailable in Hindi language. So, there is need to translate the MENQOL questionnaire in Hindi language. Aim-To study the association of functional capacity with quality of life among postmenopausal women. Methodology- Outcome measure-6-MWT, MENQOL, WHOQOL-BREF. Variables-Functional capacity, Quality of life. Method of translation-original MENQOL will be download from “Mapi Research Trust†and approval will be taken by accepting the agreement for questionnaire translation in Hindi language. Steps will be - 1. Forward translation 2. Backward translation 3. Test on participants 4. Proofreading · Validation of Hindi translated questionnaire. Protocol for assessment of functional capacity and quality of life- The participants who will fulfill the selection criteria of the criteria of the study will be selected and all the demographic details will be obtained. Written Informed consent will be provided after explaining the procedure to all the participants. Educate participants about both the questionnaires and rate them accordingly to their experiences. · MENQOL (Hindi) – For evaluation of QoL · WHOQOL-BREF (Hindi) – For evaluation of QoL Then after educate about 6-MWT procedure to the participants. For this step- Pre-test measurements (Heart rate, Blood pressure, Spo² and Rate of Perceived Exertion) will be taken. Then participants will walk on 30-meter straight walkway free from obstacle for 6 min. in their normal pace. After 6 minutes, record after measurements and distance covered by the participants. Find association between FC and QoL. |