Otago Exercise Programme and Physical Function in Older Adults in Sarawak

NCT ID: NCT07258550

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Accidental Falls Balance Assessment Physical Fitness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants were randomly assigned into two parallel groups: an intervention group receiving the Otago Exercise Programme (OEP) and a control group continuing their usual daily activities without structured exercise. Both groups were followed for 12 weeks with assessments at baseline, 6 weeks, and 12 weeks.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Triple-blind randomized controlled trial. Participants, investigators, and outcome assessors were blinded to group allocation. Randomization codes were generated and maintained by an independent coordinator until completion of all data collection and analyses to prevent bias.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental: Otago Exercise Programme (OEP)

Participants in the intervention group will receive the Otago Exercise Programme (OEP), a structured, multicomponent home- and group-based exercise programme focusing on lower-limb strength, balance, and functional mobility. Each supervised session lasts about 60 minutes and includes warm-up, strengthening, balance, and cool-down exercises. Sessions are conducted three times weekly for 12 weeks under supervision by trained facilitators, with participants encouraged to continue selected exercises at home.

Group Type EXPERIMENTAL

Otago Exercise Programme (OEP)

Intervention Type BEHAVIORAL

The Otago Exercise Programme (OEP) is a behavioural, multicomponent exercise protocol focusing on lower-limb strength, balance, and functional mobility. It includes warm-up, strengthening, balance, and cool-down components performed three times weekly for 12 weeks under trained supervision. The programme aims to improve balance, enhance lower-limb strength, and reduce fall risk among community-dwelling older adults.

No Intervention: Usual Daily Activity (Control)

Participants in the control group will continue their usual daily activities and will not participate in any structured exercise programme. They will receive general health education leaflets on physical activity and fall prevention at baseline, without additional supervised training.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Otago Exercise Programme (OEP)

The Otago Exercise Programme (OEP) is a behavioural, multicomponent exercise protocol focusing on lower-limb strength, balance, and functional mobility. It includes warm-up, strengthening, balance, and cool-down components performed three times weekly for 12 weeks under trained supervision. The programme aims to improve balance, enhance lower-limb strength, and reduce fall risk among community-dwelling older adults.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Community-dwelling older adults aged 60 to 100 years residing in Bau District, Sarawak.
* Able to ambulate independently, with or without an assistive device.
* Physically and cognitively able to participate in exercise sessions.
* Willing to provide written informed consent and commit to the 12-week programme and all scheduled assessments.
* Medically cleared for moderate-intensity exercise by a healthcare provider.

Exclusion Criteria

* Severe visual, auditory, neurological, or musculoskeletal impairment that limits safe participation in exercise.
* Unstable medical conditions (e.g., uncontrolled hypertension, recent cardiac event, severe respiratory illness).
* Cognitive impairment or diagnosed dementia preventing informed participation.
* Currently participating in any other structured exercise or physiotherapy programme.
* Any contraindication to moderate-intensity physical activity as determined by screening or medical history.
Minimum Eligible Age

60 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Malaysia Sarawak

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anselm Ting Su

Professor, Faculty of Medicine & Health Sciences, Universiti Malaysia Sarawak (UNIMAS)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dewan Tasik Biru

Bau, Sarawak, Malaysia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Malaysia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SELF-FUNDED-DRPH-2024

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UNIMAS-OEP-2024

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.