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CTRI Number  CTRI/2025/12/098468 [Registered on: 04/12/2025] Trial Registered Prospectively
Last Modified On: 03/12/2025
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   Effect of telerehabilitation on physical function in elderly  
Scientific Title of Study   Effect of telerehabilitation on physical function in pre-frail elderly 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mansi Mbmaurya  
Designation  Student  
Affiliation  School of Health Sciences Chhatrapati Shahu Ji Maharaj University kanpur nagar  
Address  School of Health Sciences Department of Physiotherapy CSJMU Kanpur Kanpur Nagar UTTAR PRADESH 208024 India

Kanpur Nagar
UTTAR PRADESH
208024
India 
Phone  7007204738  
Fax    
Email  mansimaurya117@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hina Vaish  
Designation  Assistant Professor 
Affiliation  School of Health Sciences Chhatrapati Shahu Ji Maharaj University  
Address  School of Health Sciences Department of Physiotherapy SHS 126 CSJMU Kanpur Kanpur Nagar UTTAR PRADESH 208024 India

Kanpur Nagar
UTTAR PRADESH
208024
India 
Phone  9450124758  
Fax    
Email  hinavaish@csjmu.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Hina Vaish  
Designation  Assistant Professor 
Affiliation  School of Health Sciences Chhatrapati Shahu Ji Maharaj University  
Address  School of Health Sciences Department of Physiotherapy SHS 126 CSJMU Kanpur Kanpur Nagar UTTAR PRADESH 208024 India


UTTAR PRADESH
208024
India 
Phone  9450124758  
Fax    
Email  hinavaish@csjmu.ac.in  
 
Source of Monetary or Material Support  
School of Health Sciences Department of Physiotherapy SHS 126 CSJMU Kanpur Kanpur Nagar UTTAR PRADESH 208024 India  
 
Primary Sponsor  
Name  School of Health Sciences Chhatrapati Shahu Ji Maharaj University  
Address  School of Health Sciences Department of Physiotherapy SHS 126 CSJMU Kanpur Kanpur Nagar UTTAR PRADESH 208024 India  
Type of Sponsor  Research institution 
 
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 Hina Vaish  SCHOOL OF HEALTH SCIENCES PHYSIOTHERAPY OPD  School of Health Sciences Department of Physiotherapy Physiotherapy OPD SHS 126 CSJMU Kanpur Kanpur Nagar UTTAR PRADESH 208024 India
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 CSJMU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R54||Age-related physical debility,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Simple walking   Participants will be asked to record their steps daily via a pedometer application on their mobile phones for 12 weeks  
Intervention  Telerehabilitation   Aerobic strengthening and flexibility exercises will be done through telerehabilitation and participants will be asked to record their steps daily through Pedometer app for 12 weeks  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Community adults aged 60 years and above
Pre-frail based on the Fried Frailty Criteria
Cognitive function as determined by MMSE score
Access to a smartphone with internet connectivity 
 
ExclusionCriteria 
Details  Participation in an exercise program within the past three months.
Severe visual or hearing impairments
Unstable medical conditions
Obese 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Short Physical Performance Battery
6 minute walk test  
Short Physical Performance Battery
6 minute walk test  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   20/12/2025 
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="0"
Months="3"
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  

This research proposes a pilot randomized controlled trial to evaluate the impact of a telerehabilitation program on the physical function of pre-frail older adults in India. The methodology for this RCT will involve a sample  size of 30 participants, with 15 assigned to an experimental group and 15 to a control group. Participants will be screened according to the inclusion and exclusion criteria. A screening form will be filled out by us along with a data collection form that will measure pre-test details and post-test details. Outcome measures used here will be SPPB and the 6-minute walk test. The experimental group will participate in a multicomponent telerehabilitation program three days a week for 12 weeks. Each session, lasting approximately 50 minutes, will be comprehensive, including warm-up, aerobic exercises, and strengthening and flexibility exercises. In contrast, the control group will receive instructions for a simple home-based walking regimen. Both groups will use a pedometer app to monitor and record their step count, providing a baseline for comparison between both the groups.

 
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