| 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
|
|
|
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
|
|
|
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. |