Otago Exercise Programme and Physical Function in Older Adults in Sarawak

NCT07258550 | Completed

• 2 other identifiers: UNIMAS-OEP-2024SELF-FUNDED-DRPH-2024
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Accidental Falls; Balance Assessment; Physical Fitness

Keywords

Otago Exercise Programme; Balance; Physical fitness; Quality of life; Older adults; Sarawak; Fall prevention; Community-dwelling elderly

Outcome Measures

Primary Outcomes (1)

• Balance performance measured using the Berg Balance Scale (BBS)

  Balance ability will be assessed using the Berg Balance Scale (BBS), a 14-item objective measure designed to evaluate balance in older adults. Each item is scored on a 5-point scale (0-4), with a total possible score of 56. Higher scores indicate better balance and lower fall risk.

  Baseline, 6 weeks, and 12 weeks after intervention start

Secondary Outcomes (6)

• 30-Second Chair Stand Test Performance

  Baseline, 6 weeks, and 12 weeks after intervention start

• Arm Curl Test Performance

  Baseline, 6 weeks, and 12 weeks after intervention start

• 2-Minute Step Test Performance

  Baseline, 6 weeks, and 12 weeks after intervention start

• Chair Sit-and-Reach Test Performance

  Baseline, 6 weeks, and 12 weeks after intervention start

• Back Scratch Test Performance

  Baseline, 6 weeks, and 12 weeks after intervention start

Other Outcomes (1)

• Quality of life measured using the WHOQOL-BREF questionnaire

  Baseline, 6 weeks, and 12 weeks after intervention start

Study Arms (2)

Experimental: Otago Exercise Programme (OEP)

EXPERIMENTAL

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.

Behavioral: Otago Exercise Programme (OEP)

No Intervention: Usual Daily Activity (Control)

NO INTERVENTION

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.

Interventions

Otago Exercise Programme (OEP) 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.

Experimental: Otago Exercise Programme (OEP)

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Malaysia Sarawak: lead

Study Sites (1)

Dewan Tasik Biru

Bau, Sarawak, 94000, Malaysia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Faculty of Medicine & Health Sciences, Universiti Malaysia Sarawak (UNIMAS)

Model Details: 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.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 2, 2025
• Study Start: April 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: July 31, 2024
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)