| CTRI Number |
CTRI/2024/11/076501 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Investigating how menopause length affects muscle and nerve Health in woman. |
|
Scientific Title of Study
|
Association of Menopause Duration with Neuromuscular Functions in Postmenopausal woman: A Cross-Sectional 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 No- 105, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi
New Delhi DELHI 110025 India |
| Phone |
9868023378 |
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Aqsa Khan |
| Designation |
Student |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room No- 208, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi
New Delhi DELHI 110025 India |
| Phone |
7351571257 |
| Fax |
|
| Email |
khanaqsa1257@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Majumi M Noohu |
| Designation |
Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room No- 105, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi
New Delhi DELHI 110025 India |
| Phone |
9868023378 |
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
|
Source of Monetary or Material Support
|
| Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Okhla, New Delhi-110025 |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi-110025 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
Centre for Physiotherapy and Rehabilitation Sciences |
Room No- 201, Human Performance Lab, Jamia Millia Islamia, New Delhi New Delhi DELHI |
9868023378
mnoohu@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Post-Menopausal women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Subjects who are able to walk independently without an assistive device.
Normal Hearing
Normal vision
Able to understand the commands. |
|
| ExclusionCriteria |
| Details |
History of any neurological, psychological and psychiatric disorder.
Alcoholism and other drug abuse
Chronic Hypertension
Receiving Hormonal Therapy
History of Hysterectomy
Subjects under antidepressants
Renal or endocrine disorders |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Muscle Strength
Postural Control
Cognitive Function
|
One time (on day 1) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Severity of menopausal symptoms
Physical Activity Level
Bladder Function
Anxiety
Depression
Stress
Quality of life
|
One Time (on day 1) |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
20/11/2024 |
| 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 Yet Recruiting |
| 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
|
Menopause is described as the permanent cessation of menstrual cycles, and categorized into premenopausal, perimenopause, and postmenopausal stages. Menopause has diverse effect on women health, which ultimately decreases the quality of life. To the best of my knowledge there are very limited or no evidences regarding the association of menopause duration with neuromuscular functions in postmenopausal women. The present study seeks to investigate the association of menopause duration with neuromuscular function in postmenopausal women. It includes objective assessment of postural control, muscle strength, and cognitive function in postmenopausal women with a correlation to menopause duration and a subjective evaluation of postmenopausal severity of symptom, bladder function, anxiety, stress, depression, and physical activity related to menopause duration. After selection for the study, Participant will be explained the purpose, methodology of the study. They will be further divided into into group 1 (Perimenopause), group 2 (women whose periods stopped 2 to 5 years ago) and group 3 (women whose periods stopped more than 5 years ago). The first session will help participant get comfortable with the study and involves filling out several questionnaires about symptoms related to the change in their monthly cycle, how active they are, any urinary issues, feelings of sadness or anxiety, stress levels, and how quality of life is during this phase of life. The second session will focus on testing the muscle strength (For grip strength they will be asked to squeeze the measuring device as hard as they can with their stronger hand, For ankle Strength: they will be asked to lie down with one leg straight, their foot will be held in place while they will try to lift it up against the device. Leg Strength Test: They will try to lift the heaviest weight they can once. If succeed, the weight will be increased for the next attempt), Balance (They will be asked to stand barefoot on a round board with a small gap between your feet. Tilt your body as far as you can in four directions: forward, backward, right, and left. The board will measure how much they tilt. For Reaction Time Test: Stand on the board and look at the screen, when a coloured spot appears on the screen, try to move to touch it as quickly as possible, The reaction time will be measured in four directions: forward, backward, right, and left) and memory (They will hear a series of numbers and need to repeat them in the same order and in reverse order). |