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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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).
 
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