| CTRI Number |
CTRI/2024/02/063140 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
21/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between Sedentary Lifestyles with Mental Well Being in Women after Menopause |
|
Scientific Title of Study
|
Association of Sedentary Behaviour with Mental Health, Fatigue and Quality of Life in Postmenopausal Women: An Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Majumi M Noohu |
| Designation |
Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room Number 105, Department- Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Okhla, New Delhi
South
DELHI
110025
India |
| Phone |
9868023378 |
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Majumi M Noohu |
| Designation |
Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room Number 105, Department- Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Okhla, New Delhi
South
DELHI
110025
India |
| Phone |
9868023378 |
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Adiba Abedin |
| Designation |
Postgraduate Student |
| Affiliation |
Jamia Millia Islamia |
| Address |
OPD, Department- Centre for Physiotherapy and Rehabilitation Sciences, Ground Floor, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Okhla, New Delhi
South
DELHI
110025
India |
| Phone |
9163855751 |
| Fax |
|
| Email |
adibaa14921@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Okhla, New Delhi |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Maulana Mohammad Ali Jauhar Marg, Jamia Nagar, Okhla, New Delhi - 110025 |
| Type of Sponsor |
Other [Central 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 Majumi M Noohu |
Jamia Millia Islamia |
OPD, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Okhla, New Delhi - 110025
South
DELHI |
9868023378
mnoohu@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
70.00 Year(s) |
| Gender |
Female |
| Details |
Postmenopausal women
Normal or corrected to normal vision and hearing
Able to understand the commands |
|
| ExclusionCriteria |
| Details |
Psychiatric disorders requiring drug treatment
History of any neurological disorder
Alcoholism and other drug abuse
Subjects under antidepressants
Receiving hormonal therapy
History of Hysterectomy
Any kind of musculoskeletal/neurological issues impairing writing skills
History of acute or chronic musculoskeletal impairment of lower limb |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sedentary Behvaiour Questionnaire (SBQ) |
One time only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Global Physical Activity Questionnaire (GPAQ) |
One time only |
| Hamilton Anxiety Rating Scale (HAM-A) |
One time only |
| Hamilton Depression Rating Scale (HAM-D) |
One time only |
| Perceived Stress Scale (PSS-10) |
One time only |
| Chalder Fatigue Scale (CFS) |
One time only |
| Menopause Specific Quality of Life Questionnaire (MENQOL) |
One time only |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
01/03/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Background and Aim: Sedentary behaviour has become a prevalent aspect of life, with women spending more time in sitting than men. Studies have found that sedentary behaviour is associated with poor mental health. Therefore this study aims to investigate the association between sedentary behaviour and mental health, level of fatigue and quality of life of postmenopausal.
Methodology: It will be an observational study including 300 postmenopausal women having normal or corrected to normal vision and hearing without any neurological disorder. The participants will be screened as per the eligibility criteria then after signing the informed consent, the data will be collected and all the questionnaires will be administered under supervision.
Results: Appropriate statistical analysis will be done and the results will be reported for all the outcome measures. |