| CTRI Number |
CTRI/2025/05/087663 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
24/05/2025 |
| 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 vriddamitra exercise vs modified wall suryanamaskar on mobility, flexibility, and quality of life in older adults |
|
Scientific Title of Study
|
Comparison of Structured Vriddhamitra Exercise Program versus Modified Wall Suryanamaskar on Functional Mobility, Flexibility and Quality of Life among Community-Dwelling Elderly
A Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rasika Rajesh jadhao |
| Designation |
Post Graduate Resident |
| Affiliation |
Sancheti institute for orthopedic rehabilitation college of physiotherapy |
| Address |
Sancheti institute for orthopedic rehabilitation college of physiotherapy, Department of community physiotherapy, 11/12, Thube park 11/12, narveer tanaji wadi, shivaji nagar, pune
Pune MAHARASHTRA 411005 India |
| Phone |
9370214900 |
| Fax |
|
| Email |
rasikajadhao1409@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Apurv Shimpi |
| Designation |
Principle and professor |
| Affiliation |
Sancheti institute for orthopedic rehabilitation college of physiotherapy |
| Address |
Sancheti institure for orthopaedic rehabilitation college of physiotherapy, Department of community physiotherapy, 11/12, Thube park, 11/12, Narveer tanaji wadi, shivajinagar, pune
Pune MAHARASHTRA 411005 India |
| Phone |
9890183195 |
| Fax |
|
| Email |
apurvshimpi@sha.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Apurv Shimpi |
| Designation |
Principle and professor |
| Affiliation |
Sancheti institute for orthopedic rehabilitation college of physiotherapy |
| Address |
Sancheti institure for orthopaedic rehabilitation college of physiotherapy, Department of community physiotherapy, 11/12, Thube park, 11/12, Narveer tanaji wadi, shivajinagar, pune
Pune MAHARASHTRA 411005 India |
| Phone |
9890183195 |
| Fax |
|
| Email |
apurvshimpi@sha.edu.in |
|
|
Source of Monetary or Material Support
|
| nil |
| Sancheti institute for orthopaedic and rehabilitation college of physiotherapy, Pune, Maharashtra, 411005 India |
|
|
Primary Sponsor
|
| Name |
Sancheti institute for orthopaedic and rehabilitation college of physiotherapy |
| Address |
sancheti institute for orthopedic and rehabilitation college of physiotherapy, thube park, 11/12, narveer tanaji wadi, shivajinagar, pune, 411005 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Rasika jadhao |
Sancheti institute for orthopaedic and rehabilitation college of physiotherapy |
Sancheti institute for orthopaedic and rehabilitation college of physiotherapy, Department of community physiotherapy, 11/12, Thube park, shivaji nagar pune-411005 Pune MAHARASHTRA |
9370214900
rasikajadhao1409@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti institute for orthopaedic and rehabilitation institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Community Dwelling elderly |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Modified wall suryanamaskar |
It involves safer and more accessible alternative than traditional suryanamaskar for elderly by providing support, reduce risk of fall and henceforth improve mobility, flexibility, and quality of life in community dwelling elderly. The modification includes performing sequence in standing position with the support of a wall to ensure safety. participants perform modified wall suryanamaskar for 30-40 mins of session for 3 days/week for 3 cycle of repetition and till RPE reaches 3-5 holding each asana for 5 sec repetitions with prior warm up followed by cool down session. |
| Intervention |
structured vriddhamitra exercise program |
Vriddhamitra is a flagship initiative of school that focuses on building an age friendly ecosystem for the elderly population in india. It involves exercise program that includes aerobic, resistance, flexibility, and balance that is important to achieve maximum benefit for community dwelling elderly. Participants will perform exercise protocol for frequency of 3 days/week for 4 weeks with intensity of moderate(RPE 3-5) with time 20-30 mins with 8-12 reps for 2 sets. which is prior done by warm up and followed by cool down session. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Community-dwelling elderly individuals aged 60-75 years.
2. Able to stand and perform mild to moderate physical activity with or without minimal support. |
|
| ExclusionCriteria |
| Details |
1.Individuals with severe musculoskeletal disorders (e.g., advanced osteoarthritis, recent fractures, or severe osteoporosis) that limit movement.
2.History of neurological disorders (e.g., stroke, Parkinson’s disease) affecting balance and mobility.
3.Presence of uncontrolled cardiovascular conditions (e.g., recent myocardial infarction, uncontrolled hypertension).
4.Individuals currently participating in any physical fitness program or yoga programs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Timed up and go test(TUG) |
At baseline (0 weeks) & after intervention (after 4
weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2.Chair sit & reach test
3.WHOQOL-BREF |
At baseline (0 weeks) & after intervention (after 4
weeks) |
|
|
Target Sample Size
|
Total Sample Size="74" Sample Size from India="74"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
23/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/06/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" 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
|
Aging leads to reduced mobility, joint stiffness, balance impairments, and decreased flexibility, increasing the risk of falls and limiting daily activities. Community dwelling elderly individuals often face multiple physical, and environmental barriers such as lack access to appropriate exercise facilities discourage participation in exercise program.The Vriddhamitra Structured Exercise Program is designed to improve functional mobility, balance, flexibility, and endurance through a combination of strength training, aerobic exercises, and mobility drills. It focuses on progressive, structured movements that enhance daily functional abilities and help prevent falls. On the other hand, Modified Wall Suryanamaskar is an adapted form of the traditional Surya Namaskar (Sun Salutation), performed with wall support, making it accessible to the elderly. This study aims to test the effects of structured vriddhamitra exercise program and modified wall suryanamaskar on functional mobility, flexibility and quality of life among community dwelling elderly. Null Hypothesis (H0) : There is no significant difference between the Structured Vriddhamitra Exercise Program and Modified Wall Suryanamaskar in improving functional mobility, flexibility, and quality of life among community-dwelling elderly Alternate Hypothesis(H1) : The Structured Vriddhamitra Exercise Program and Modified Wall Suryanamaskar have significantly different effects on functional mobility, flexibility, and quality of life among community-dwelling elderly. |