| CTRI Number |
CTRI/2025/09/094659 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of mind body and strengthening exercises on age related weakness and quality of life in elderly. |
|
Scientific Title of Study
|
Effect of Baduanjin and Resistance Band exercises on Frailty and Quality of life in Elderly: A Randomized Controlled Trail. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Adishree Devendra Kenkre |
| Designation |
Post Graduate student of Master of Physiotherapy |
| Affiliation |
Goa Medical College and Hospital |
| Address |
Shaunak 674/1 Thana Cortalim Goa 403710 Allied Health Science Courses, Department of Orthopedics, Goa Medical College and Hospital, N17 Bambolim, Tiswadi Goa 403202 North Goa GOA 403710 India |
| Phone |
9637416444 |
| Fax |
|
| Email |
adishreekenkre@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Pamela Virgil DSilva |
| Designation |
Lecturer in Physiotherapy |
| Affiliation |
Goa Medical College |
| Address |
Second floor Faculty Block,Goa Medical College and Hospital,N17 Bambolim Tiswadi Goa 403202
North Goa GOA 403202 India |
| Phone |
7353594793 |
| Fax |
|
| Email |
pamela.dsilva@ymail.com |
|
Details of Contact Person Public Query
|
| Name |
Adishree Devendra Kenkre |
| Designation |
Post Graduate student of Master of Physiotherapy |
| Affiliation |
Goa Medical College and Hospital |
| Address |
Shaunak 674/1 Thana Cortalim Goa 403710 Allied Health Science Courses, Department of Orthopedics, Goa Medical College and Hospital, N17 Bambolim, Tiswadi Goa 403202 North Goa GOA 403710 India |
| Phone |
9637416444 |
| Fax |
|
| Email |
adishreekenkre@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd 5 Department of Geriatrics Goa Medical College and Hospital N17 Bambolim Tiswadi Goa 403202 |
|
|
Primary Sponsor
|
| Name |
Adishree Devendra Kenkre |
| Address |
Shaunak 674/1
Thana Cortalim Goa
403710 |
| Type of Sponsor |
Other [Self] |
|
|
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 Adishree Devendra Kenkre |
Goa Medical College and Hospital |
First floor, Department of Geriatrics, Goa Medical College and Hospital, N17 Bambolim, Tiswadi Goa 403202 North Goa GOA |
9637416444
adishreekenkre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Goa Medical College |
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 |
| Intervention |
Baduanjin and Resistance Band exercises |
Participants in the Experimental Group will perform Baduanjin exercises for 20 minutes per session
5 consecutive days per week throughout the 8 week intervention period. In addition they will undergo resistance band training for 20 minutes per session on Day 1 Day 2 Day 4 and Day 5 of each intervention week. According to the ACSM Guidelines for Exercise Testing and Prescription the resistance training will be structured as follows
Lower limb muscles on Day 1 and Day 4
Upper limb muscles on Day 2 and Day 5
The intervention will be carried out for a total duration of 8 weeks. |
| Comparator Agent |
Conventional Exercises |
Frequency: 3 times/week
Repetitions: 10 reps x 2 set
Duration: 30-40 minutes per session
Program Duration: 8 weeks
Setting: Supervised at first, then self-led
Progression: Increase from 10 reps to 12–15 reps by week 4–6 (if tolerated). The exercises will be tailor made for each participant.
Exercises
1.Sit to Stand from chair
2.Heel Raises
3.Step Ups from a low platform
4.Seated Leg Raises
5.Arm Raises front and Sideways
6.Marching on spot
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Elderly individuals of all genders, aged 60- 75 years.
Participants scoring 8 to 11 on the Edmonton
Frailty Scale (indicating mild to moderate
frailty) and MMSE score of more than 18.
Able to walk independently with or without assistive device.
Willing to participate and provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
Unstable medical condition (like heart failure, Acute MI, Unstable angina, cardiac pacemaker)
Severe visual impairment not correctable by glasses, contact lenses, or surgery.
Currently enrolled in another physical exercise program during the study period.
Neurologic conditions affecting mobility.
Recent surgeries (within the past 6 months) or advanced Orthopaedic condition limiting mobility.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Edmonton Frailty Scale
RAND SF-36 Konkani version |
T0 Baseline
T1 4 weeks
T2 post intervention at 8 weeks
T3 follow up at 10 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Montreal Cognitive Assessment MoCA |
T0 Baseline
T1 4 weeks
T2 post intervention at 8 weeks
T3 follow up at 10 weeks
|
| Berg Balance Scale |
T0 Baseline
T1 4 weeks
T2 post intervention at 8 weeks
T3 follow up at 10 weeks
|
| Grip Strength and Quadriceps Strength using Hand Held Camry Dynamometer |
T0 Baseline
T1 4 weeks
T2 post intervention at 8 weeks
T3 follow up at 10 weeks
|
| Timed Up and Go Test |
T0 Baseline
T1 4 weeks
T2 post intervention at 8 weeks
T3 follow up at 10 weeks
|
| 4 minute walk test |
T0 Baseline
T1 4 weeks
T2 post intervention at 8 weeks
T3 follow up at 10 weeks
|
|
|
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)
|
01/10/2025 |
| 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="1" Months="0" 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
|
Frailty is a common condition in older adults that leads to weakness, reduced independence, and poor quality of life. Regular exercise has been shown to improve strength and overall well being in elderly. Baduanjin, a traditional for of gentle exercise, and resistance band training may provide combined benefits for improving frailty. The aim of this study is to evaluate the effect of Baduanjin exercises combined with resistance band exercises on frailty and quality of life in older adults, and to compare these effects with conventional exercise programs. Participants between 60-75 years of age with frailty will be included in the study. They will be randomly assigned into two groups. One group will perform Baduanjin and resistance band exercises for 40 minutes, five days per week for 8weeks. The other group will perform conventional exercises for the same duration and frequency. Frailty status and quality of life will be measured before and after the intervention using standard assessment tools. This study will help determine the effect of Badaunjin combined with resistance band training on frailty in elderly. |