| CTRI Number |
CTRI/2024/05/067295 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2026 |
| 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 Personalized Multicomponent Exercise For Improving Performance Of Daily Activities in Old Age Home Residents. |
|
Scientific Title of Study
|
Effect Of Tailored Multicomponent Exercise For Improving Functional Capacity In Old Age Home Residents: A Randomized 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 |
Janhavi Prakash |
| Designation |
PG Student |
| Affiliation |
The Oxford College of Physiotherapy |
| Address |
The Department of Musculoskeletal Sciences- Physiotherapy,
No.6/9, 1st Cross, Begur Road, Hongasandra, Bangalore-560068 Karnataka
Bangalore
KARNATAKA
560068
India |
| Phone |
9742812975 |
| Fax |
|
| Email |
janhavi.prakash1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Rucha Bhaskarwar |
| Designation |
Asso. Professor |
| Affiliation |
The Oxford College Of Physiotherapy |
| Address |
The Department of Musculoskeletal Sciences- Physiotherapy,
No.6/9, 1st Cross, Begur Road, Hongasandra, Bangalore-560068 Karnataka
Bangalore
KARNATAKA
560068
India |
| Phone |
9960809575 |
| Fax |
|
| Email |
dr.richa29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Vasanthan |
| Designation |
Principal |
| Affiliation |
The Oxford College Of Physiotherapy |
| Address |
The Department of Musculoskeletal Sciences- Physiotherapy,
No.6/9, 1st Cross, Begur Road, Hongasandra, Bangalore-560068 Karnataka
Bangalore
KARNATAKA
560068
India |
| Phone |
9916919685 |
| Fax |
|
| Email |
physiotherapyprincipal@theoxford.edu |
|
|
Source of Monetary or Material Support
|
| Kashika Seva Trust, #133, Bank of Baroda Building, 4th Floor, Vijayashree Layout, 1st Main, Hulimavu Gate, Bannerghatta Road, Bangalore 560076, Karnataka |
| Maanasa Mandiraa Old age home, #29/50, 10th Cross, 9th Main, Tavarekere Main Road, KEB Layout, First Stage, BTM Layout, Bangalore 560029 |
| Nethu Priyaa Home for Elders, 1st Cross, 2nd Main, 2nd Stage Arekere, Mico Layout, Bannerghatta Road, Bangalore 560076, Karnataka |
| Omashram Trust, 3rd Main, Vijayashree Layout, Hulimavu Gate, Bannerghatta Road, Bangalore - 560076, Karnataka |
| Sai Kuteera Old age home,51RTO office, 19th main, BTM 4th stage, Bangalore 560076, Karnataka |
| Sri Chaithanya Oldage Home,#267, 16th Cross, 24th Main, JP Nagar 5th Phase, Bangalore 560078, Karnataka |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Janhavi Prakash |
The Oxford College of Physiotherapy |
The Department of Musculoskeletal Sciences- Physiotherapy,
No.6/9, 1st Cross, Begur Road, Hongasandra, Bangalore-560068 Karnataka
Bangalore
KARNATAKA |
9742812975
janhavi.prakash1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Oxford College of Physiotherapy Review Board for Ethics and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Old age home residents from age 60 to 74 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Exercise based on WHO physical activity guidelines |
Aerobic and strengthening exercises according to the WHO physical activity guidelines for older adults.
4 weeks protocol. 3 days a week. |
| Intervention |
Multicomponent training |
VIVIFRAIL Multicomponent Physical Exercise Program (MPEP) which includes strength, cardiovascular, balance and flexibility exercises.
4 weeks protocol. 3 days a week. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
74.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 60 to 74 years.
Both males and females.
Physically active individuals. (IPAQ- low and moderate)
Able to perform their own ADL (ADLQ- 0 to 66%)
Moderate aerobic capacity (walking speed test) |
|
| ExclusionCriteria |
| Details |
Myocardial infarction in the past 3 months.
Unstable angina pectoris
Terminal illness
Uncontrolled arrhythmias
Unstable cardiovascular disease or other unstable medical condition.
Uncontrolled arterial hypertension
Recent pulmonary thromboembolism
Upper or lower extremity fracture in the past 3 months
Institutionalized or pending entry into institution
Unwillingness to either complete the study requirements or to be randomized into the control or the intervention group.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Short Physical Performance Battery (SPPB)
|
0 week and 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Timed Up and Go test (TUG) |
0 week and 4th week |
| Modified falls efficacy scale (MFES) |
0 week and 4th week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
27/05/2024 |
| 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="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
Modification(s)
|
Background: The global demographic transition of recent decades has resulted in a significant increase in life expectancy, leading to a higher proportion of older adults worldwide. The aging population globally faces challenges associated with physical inactivity, leading to a decline in muscle function, ultimately contributing to frailty. Despite advances in medicine, frailty syndrome remains prevalent among older adults, characterized by loss of muscle mass and strength, leading to poor functional ability, fatigue, and falls. Maintaining independence and functional ability is paramount for the elderly to lead fulfilling lives. This emphasizes the importance of exercise programs to maintain independence. Multicomponent exercise programs have emerged as promising interventions to address these issues by preserving muscle mass, strength, and overall physical capacity. The VIVIFRAIL multicomponent exercise program aims to prevent frailty and falls by tailoring exercises to individual needs. While multicomponent training has shown promise, there’s a need to assess its effectiveness in older populations in countries with an accelerated aging process. This study evaluates the impact of VIVIFRAIL-based exercises on functional capacity in old age home residents, focusing on fall risk reduction and confidence in daily activities compared to WHO exercise guidelines for the older population. Method: In this parallel group RCT study, 50 participants aged 60-74 years from old age homes in Bangalore will be enrolled in a 4-week exercise program. Participants will be allocated randomly into two groups. Group A will receive the exercises based on VIVIFRAIL protocol and Group B will receive an exercise program based on WHO guidelines for the older population for a total of 4 weeks. Outcome Measures: The outcome measures used will be Short Physical Performance Battery (SPPB), Timed up and go (TUG) test and the Modified falls efficacy scale which will be recorded at baseline and the 4th week. Data Analysis: The results will be analyzed using descriptive statistics and independent t test.
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