| CTRI Number |
CTRI/2022/10/046680 [Registered on: 20/10/2022] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effect of exercise on older adults who have decreased muscle strength, muscle mass, and quality of life. |
|
Scientific Title of Study
|
Effect of Reablement Strategies targeting Sarcopenia (ReStart-S) on muscle parameters, functional activities, and quality of life among older adults residing in long term care settings-A Cluster randomized trial |
| Trial Acronym |
ReStart-S |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prabal Kumar |
| Designation |
PhD Scholar |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy,
Manipal College of Health Professions,
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9870656646 |
| Fax |
|
| Email |
kprabal000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girish N |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy,
Manipal College of Health Professions,
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886782114 |
| Fax |
|
| Email |
girish.n@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashikiran Umakanth |
| Designation |
Medical Superintendent |
| Affiliation |
Dr TMA Pai Hospital, Manipal Academy of Higher Education |
| Address |
Department of Medicine,
Dr. TMA Pai Hospital,
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576101
India |
| Phone |
9008418171 |
| Fax |
|
| Email |
shashikiran.u@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
|
|
Primary Sponsor
|
| Name |
Prabal Kumar |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prabal Kumar |
A V BALIGA HOME FOR SENIOR CITIZENS |
Visitors lobby
Udupi
KARNATAKA |
9870656646
kprabal000@gmail.com |
| Prabal Kumar |
KARUNALAYA CHARITABLE TRUST |
Dining hall
Udupi
KARNATAKA |
9870656646
kprabal000@gmail.com |
| Prabal Kumar |
KUTEERA OLD AGE HOME |
Dining hall
Udupi
KARNATAKA |
9870656646
kprabal000@gmail.com |
| Prabal Kumar |
OZANAM HOME FOR THE AGED |
Dining hall
Udupi
KARNATAKA |
9870656646
kprabal000@gmail.com |
| Prabal Kumar |
SRI KRISHNA OLD AGE HOME |
Corridor
Udupi
KARNATAKA |
9870656646
kprabal000@gmail.com |
| Prabal Kumar |
VISHRANTHI DHAMA OLD AGE HOME |
Common activity room
Udupi
KARNATAKA |
9870656646
kprabal000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Daily usual activities |
Participants whose cluster (long term care setting) falls in the control group will be asked to continue with their daily usual activities. |
| Intervention |
Reablement Strategies targeting Sarcopenia (ReStart-S) program |
Participants whose cluster (long term care setting) falls in the intervention group will undergo the ReStart-S program. The ReStart-S program will be designed in the first phase and will consist of resistance exercise, aerobic exercise, balance exercise and flexibility exercise. The exercises will be delivered following the FITT principle (Frequency, Intensity, Time and Type). The components, time per session and total duration of the ReStart-S program will be finalised after the first phase (minimum 2/week, minimum of 30 minutes/session for a minimum of 6 weeks). |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
(1) either gender, (2) more than or equal to 60 years of age to less than or equal to 99 years, (3) Barthel index more than or equal to 60 points, (4) Mini cog score more than or equal to 2 and normal clock drawing, (5) Sarcopenia as per the Asian Working Group for Sarcopenia 2019 (AWGS 2019) guidelines cut-off that is: (a) Appendicular skeletal muscle mass: <7.0 kilogram per meter square in men and <5.7 kilogram per meter square in women, (b) Hand Grip Strength: <28.0 kilogram for men and <18.0 kilogram for women, (c) Short Physical Performance Battery: less than or equal to 9 |
|
| ExclusionCriteria |
| Details |
(1) Critically ill/ Terminally ill/ Active infection, (2) Pacemaker and any metal implant, (3) Bed bound/wheelchair bound, (4) Acute onset (less than 30 days) of cardiorespiratory/neurological/renal/orthopaedic disease |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hand Grip Strength (HGS, Kilogram) |
0 week (baseline assessment), 6 weeks (minimum intervention duration), 12 weeks (minimum follow up duration post intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| (1) Physical performance: Short Physical Performance Battery (SPPB), (2) Muscle mass: Appendicular skeletal muscle mass (ASM, Kilogram/meter square), (3) Biomarker: C-terminal Agrin Fragment (CAF, nanograms per milliliter), (4) Activities of daily living: Katz Index of Independence in Activities of Daily Living, (5) Quality of life- Sarcopenia and Quality of Life questionnaire (SarQoL) |
0 week (baseline assessment), 6 weeks (minimum intervention duration), 12 weeks (minimum follow up duration post intervention) |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
Final Enrollment numbers achieved (Total)= "78"
Final Enrollment numbers achieved (India)="78" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/02/2023 |
| Date of Study Completion (India) |
30/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
With the growing population of the elderly around the world, the number of people affected by sarcopenia is expected to rise and will face the necessity to relocate to long term care settings. The sarcopenia reduces the muscle parameters, decline functional activities, and reduced quality of the life making them vulnerable to frailty. Sarcopenic changes are associated with number of adverse events like falls, fracture, loss of independence, and frequent hospitalization which increases health care cost bear by older adults residing in long term care setting. Hence, there is a need to preserve and improve the muscle parameters, functional activities, and quality of life of older adults with sarcopenia residing in long term care settings. Thus the objective of the study are:Phase 1: To design and validate Reablement Strategies targeting Sarcopenia (ReStart-S) among older adults residing in long term care settings Phase 2: To evaluate the effect of the ReStart-S program on muscle strength, physical performance, muscle mass, biomarkers, activities of daily living and quality of life among older adults residing in long term care settings |