Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-01 @ 2:18 PM
Study NCT ID:
NCT07258550
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Otago Exercise Programme and Physical Function in Older Adults in Sarawak
Sponsor:
University Malaysia Sarawak
Organization:
Study Overview
Official Title:
Effects of the Otago Exercise Programme on Senior Physical Fitness, Balance, and Quality of Life Among Older Adults in Sarawak: A Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OEP
Brief Summary:
This randomized controlled trial aims to evaluate the effects of the Otago Exercise Programme (OEP) on physical fitness, balance, and quality of life among older adults in Sarawak, Malaysia. The intervention involves a structured home-based and group-supervised exercise programme focused on lower-limb strength and balance training. A total of 120 community-dwelling older adults aged 60 years and above were recruited from Bau District, Sarawak, and randomized into intervention (OEP) and control groups. The intervention group participated in the OEP for 12 weeks, while the control group maintained their usual activities.
Assessments were conducted at baseline, 6 weeks, and 12 weeks using the Senior Fitness Test (SFT), Berg Balance Scale (BBS), and WHOQOL-BREF to evaluate changes in physical fitness, balance, and quality of life. The study aims to provide evidence on the effectiveness of OEP as a feasible, community-based fall-prevention and functional fitness programme for older adults in Malaysia. Findings will contribute to national healthy ageing policy and rehabilitation strategies under the WHO Decade of Healthy Ageing (2021-2030) framework.
Assessments were conducted at baseline, 6 weeks, and 12 weeks using the Senior Fitness Test (SFT), Berg Balance Scale (BBS), and WHOQOL-BREF to evaluate changes in physical fitness, balance, and quality of life. The study aims to provide evidence on the effectiveness of OEP as a feasible, community-based fall-prevention and functional fitness programme for older adults in Malaysia. Findings will contribute to national healthy ageing policy and rehabilitation strategies under the WHO Decade of Healthy Ageing (2021-2030) framework.
Detailed Description:
This study used a two-arm, parallel-group randomized controlled trial design to evaluate the effectiveness of the Otago Exercise Programme (OEP) in improving physical fitness, balance, and functional mobility among community-dwelling older adults in the Bau District of Sarawak, Malaysia.
Participants were screened for eligibility and safety using clinical history, medical clearance forms, and physical readiness questions. Randomization was conducted using computer-generated permuted blocks, with allocation sequences prepared and concealed by an independent coordinator not involved in assessment or intervention delivery.
The intervention protocol followed the standardized OEP training manual and included lower-limb strengthening, balance exercises, functional mobility tasks, and progressive walking prescriptions. Participants performed three weekly home-based sessions supported by weekly group-supervised sessions led by trained facilitators. Exercise progression was individualized according to participant capability and safety guidelines.
Outcome assessments were conducted at baseline, week 6, and week 12 by assessors who were blinded to group allocation. Standardized measurement procedures were used following the Senior Fitness Test (SFT) manual and the Berg Balance Scale (BBS) assessment protocol. Adverse events and training adherence were monitored throughout the intervention period.
The study operated under ethical approval from the Medical Research Ethics Committee, Universiti Malaysia Sarawak (Ref: FME/24/115). This project was conducted as part of a Doctor of Public Health (DrPH) research requirement. Findings are expected to contribute evidence for community-based fall-prevention strategies and healthy ageing programmes in Malaysia.
Participants were screened for eligibility and safety using clinical history, medical clearance forms, and physical readiness questions. Randomization was conducted using computer-generated permuted blocks, with allocation sequences prepared and concealed by an independent coordinator not involved in assessment or intervention delivery.
The intervention protocol followed the standardized OEP training manual and included lower-limb strengthening, balance exercises, functional mobility tasks, and progressive walking prescriptions. Participants performed three weekly home-based sessions supported by weekly group-supervised sessions led by trained facilitators. Exercise progression was individualized according to participant capability and safety guidelines.
Outcome assessments were conducted at baseline, week 6, and week 12 by assessors who were blinded to group allocation. Standardized measurement procedures were used following the Senior Fitness Test (SFT) manual and the Berg Balance Scale (BBS) assessment protocol. Adverse events and training adherence were monitored throughout the intervention period.
The study operated under ethical approval from the Medical Research Ethics Committee, Universiti Malaysia Sarawak (Ref: FME/24/115). This project was conducted as part of a Doctor of Public Health (DrPH) research requirement. Findings are expected to contribute evidence for community-based fall-prevention strategies and healthy ageing programmes in Malaysia.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| SELF-FUNDED-DRPH-2024 | OTHER_GRANT | Dr Saravanan Muruthamuthu (self-funded DrPH) | View |