Home » Trials » SLCTR/2025/003
The impact of culturally- adapted resistance training on muscle strength, respiratory function and physical performances in institutionalized older adults (IOA)
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SLCTR Registration Number
SLCTR/2025/003
Date of Registration
The date of last modification
Feb 01, 2025
Scientific Title of Trial
The impact of culturally- adapted resistance training on muscle strength, respiratory function and physical performances in institutionalized older adults (IOA)
Public Title of Trial
The effect of a newly developed strength training programme on lower limb muscles strength, respiratory function and physical performances compared to usual care in institutionalized older adults (IS) - A quasi-experimental trial.
Disease or Health Condition(s) Studied
Functional capacity in older age.
Scientific Acronym
Institutionalized older adults (IOA)
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1315-7961
Any other number(s) assigned to the trial and issuing authority
ERC 26/24 (Faculty of Medical Sciences, Sri Jayewardenepura)
What is the research question being addressed?
What is the effect of a culturally adapted resistance training programme on lower limb muscle strength, respiratory function and physical performances compared to usual care in institutionalized elderly in Sri Lanka?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Single blinded : Outcome assessors
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Other
Study Phase
Not Available
Intervention(s) planned
Study setting The study will be conducted in Piliyandala and Dompe MOH areas.
Study population Older adults who are in the elders' homes in Piliyandala and Dompe MOH areas will be considered for the study.
Sampling method A cluster random sampling method – All elders’ homes which are registered under the social service department in Piliyandala and Dompe MOH areas will be considered, and each one will be a cluster. Clusters will be randomized to 2 groups (intervention and control) in both settings using simple randomization (allocation ratio 1:1). For the selection of clusters; a number will be given to each home and a random number will be selected using a computer-generated method. Thus, the first matched number will be allocated to the intervention group, the second to the control group.
Intervention group- Components of the programme- 1. Warm-up and stretching exercises for upper limbs and lower limbs for 5 minutes 2. Resistance training programme- 30-40% of 1 repetition maximum (RM -most weight a person can lift for a single repetition) for both lower limb muscles, 5-8 repetitions, 2 sets, 2 times per week for 6 months.
Control group- Standard protocol (routine physical activities) which is already practiced in the elderly homes.
Inclusion criteria
Older adults (males and females) aged between 60 to 75 years in the elders’ homes at Piliyandala and Dompe MOH areas.
Exclusion criteria
Older adults: • with severe (according to the severity scale) osteoarthritis, rheumatoid arthritis, osteoporosis, or any muscular disorders. • with recent fractures (less than 3 months), pelvis, hip, lower limb deformities, and leg length discrepancy. • with diagnosed cardiovascular diseases and respiratory diseases. • diagnosed with poorly controlled major psychiatric diseases (schizophrenia, bipolar disorders, etc.). • who cannot understand the content of questionnaires (moderate-severe cognitive impairment). • who have contraindications to perform spirometry; those who have respiratory symptoms within two months; those who are diagnosed with and treated for acute respiratory diseases (coronavirus disease, acute pneumonia, acute bronchitis, etc.) within 2 months; and those with acute cardiovascular disease, acute thoracic /abdominal surgery, eye surgery< 4 weeks and hemoptysis. • who are severely ill.
Primary outcome(s)
|
1.
Mean Muscle strength of lower limbs- Handheld dynamometry (HHD) in Newtons (N) |
[ baseline, one month, three months and six months. ] |
|
2.
Physical performances -Mean scores of the SPPB Short Physical Performance Battery (SPPB) is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults. |
[ baseline, one month, three months and six months. ] |
|
3.
Respiratory function - Mean Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and peak expiratory flow rate (PEF) using a spirometer |
[ baseline, one month, three months and six months. ] |
Secondary outcome(s)
|
1.
Food consumption will be assessed by using a 24-hour dietary recall and a 3-day diet diary |
[ 1 month, 3 months and 6 months. ] |
Target number/sample size
60 (30 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2025-02-03
Anticipated end date
2026-01-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Self funding
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2024-08-22
Approval number
ERC 26/24
Details of Ethics Review Committee
| Name: | The research ethics committee of FOM, University of Sri Jayawardanapura |
| Institutional Address: | Faculty of Medical Sciences, University of Sri Jayewardenepura Gangodawila, Nugegoda, Sri Lanka |
| Telephone: | 94-11-2758588, |
| Email: | erc.fms@sjp.ac.lk |
Contact person for Scientific Queries/Principal Investigator
G.A.D.Perera
Senior Lecturer
Faculty of Allied Health Sciences
General Sir John Kotelawala Defence University
Ratmalana
94-11-2638656
0714444010
amaradamayanthi@kdu.ac.lk
https://kdu.ac.lk/
Contact Person for Public Queries
G.A.D.Perera
Senior Lecturer
Faculty of Allied Health Sciences
General Sir John Kotelawala Defence University
Ratmalana
94-11-2638656
0714444010
amaradamayanthi@kdu.ac.lk
https://kdu.ac.lk/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
