FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/11/028904 [Registered on: 04/11/2020] Trial Registered Prospectively
Last Modified On: 28/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A trial to study the effect of a fitness programme delivered through technological systems for women approaching menopause 
Scientific Title of Study   The effect of an exercise programme delivered through tele-rehabilitation systems on fitness and quality of life in perimenopausal women : A randomised control trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Apurv P Shimpi PT 
Designation  Professor and Head, Department of Community Physiotherapy 
Affiliation  Sancheti Institute College of Physiotherapy 
Address  Department of community physiotherapy, Sancheti Institute College of Physiotherapy 11/12, Thube park, Shivajinagar, Pune, Maharashtra 411005 India

Pune
MAHARASHTRA
411005
India 
Phone  919890183195  
Fax    
Email  apurvshimpi@sha.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Eden Mehdiabadi PT 
Designation  Physiotherapist, Community Physiotherapy Department 
Affiliation  Sancheti Institute College of Physiotherapy 
Address  Department of community physiotherapy, Sancheti Institute College of Physiotherapy 11/12, Thube park, Shivajinagar, Pune, Maharashtra 411005 India
i/17, Gita Society, 10 Synagogue street, Pune - 411002
Pune
MAHARASHTRA
411005
India 
Phone  919049266893  
Fax    
Email  karen.eden.m@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Eden Mehdiabadi PT 
Designation  Physiotherapist, Community Physiotherapy Department 
Affiliation  Sancheti Institute College of Physiotherapy 
Address  Department of community physiotherapy, Sancheti Institute College of Physiotherapy 11/12, Thube park, Shivajinagar, Pune, Maharashtra 411005 India
i/17, Gita Society, 10 Synagogue street, Pune - 411002
Pune
MAHARASHTRA
411005
India 
Phone  919049266893  
Fax    
Email  karen.eden.m@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Sancheti Institute College of Physiotherapy 
Address  Sancheti Institute College of Physiotherapy 11/12, Thube park, Shivajinagar, Pune, Maharashtra 411005 India 
Type of Sponsor  Research institution and hospital 
 
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 
DrEden Mehdiabadi  Sancheti Institute college of physiotherapy   community setting, department of physiotherapy, Sancheti institute college of physiotherapy, Thube park, Shivaji Nagar, Pune - 411002
Pune
MAHARASHTRA 		 9049266893

karen.eden.m@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sancheti Institute for Orthopaedics and Rehabilitation, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Perimenopausal women 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Exercise programme  Conventionally delivered home exercise programme 5 days a week for 6 weeks 
Intervention  Exercise programme  delivered through tele-rehabilitation systems 5 days a week for 6 weeks  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Perimenopausal women between 45 - 60 years of age
Experiencing one or more climacteric symptoms which can affect their quality of life - Skipped periods, Hot flashes, Sleep disturbances, Headaches, Mood swings, Urinary incontinence, Weight gain
Having access to mobile phones with internet facility and can be used for video calling
 
 
ExclusionCriteria 
Details  Women on hormone replacement therapy
Surgical menopause
Physically active women exercising more than 2 times per week for at least 30 minutes each time
Having active psychological disorders or taking psychiatric medication
Uncontrolled hypo/hyperthyroidism
Any contraindications to physical activity  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Aerobic capacity - Incremental Shuttle Walk test   Baseline and 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Measures of body composition - Height, Weight, BMI, Body fat %, Muscle mass, Bone mass, total body water %, Visceral fat level.
Muscular fitness - modified push up test, one minute curl up test, squat test
Musculoskeletal Flexibility - Sit and reach test
Menopause specific Quality of Life Questionnaire (MENQOL) 		 Baseline and 6 weeks 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   15/11/2020 
Date of Study Completion (India) 31/05/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

This study was a randomised, single blinded, parallel group, active controlled study comparing the effect of an exercise programme delivered through tele-rehabilitation to one group and conventionally as a home programme to another group of perimenopausal women. The outcome measures were assessed which included the components of their fitness, and their quality of life before and after the intervention.


The results of the study showed that exercises through both modes of delivery were effective in improving health related fitness parameters and improving quality of life of perimenopausal women.


Conclusion :

Both, Tele-rehabilitation and conventional modes of exercise delivery are equally effective in delivering an exercise programme to improve fitness and quality of life of perimenopausal women.

 
Close