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Completed

NCT Number: NCT07258550

Otago Exercise Programme and Physical Function in Older Adults in Sarawak

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.

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Key information

Conditions

Accidental Falls Balance Assessment Physical Fitness

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dewan Tasik Biru

Bau, Sarawak, 94000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Balance performance measured using the Berg Balance Scale (BBS)

    Time frame: Baseline, 6 weeks, and 12 weeks after intervention start

    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.

Secondary outcomes

  1. 30-Second Chair Stand Test Performance

    Time frame: Baseline, 6 weeks, and 12 weeks after intervention start

    The 30-second chair stand test will assess lower-body strength. Participants will be instructed to stand up fully and sit down as many times as possible within 30 seconds. Higher scores represent greater lower-body strength.

  2. Arm Curl Test Performance

    Time frame: Baseline, 6 weeks, and 12 weeks after intervention start

    Upper-body strength will be assessed using the Arm Curl Test. Participants will perform as many arm curls as possible in 30 seconds using a standardized dumbbell (5 lbs for women and 8 lbs for men). A higher number of repetitions indicates greater upper-body strength.

  3. 2-Minute Step Test Performance

    Time frame: Baseline, 6 weeks, and 12 weeks after intervention start

    Aerobic endurance will be assessed using the 2-minute step test. Participants will march in place for 2 minutes, lifting the knees to a height midway between the patella and iliac crest. The number of steps meeting the required height will be counted. Higher numbers indicate greater aerobic endurance.

  4. Chair Sit-and-Reach Test Performance

    Time frame: Baseline, 6 weeks, and 12 weeks after intervention start

    Flexibility will be assessed using the chair sit-and-reach test. Participants will sit on the edge of a chair with one leg extended and reach toward the toes. The distance reached (positive score for reaching past the toes, negative score if short of toes) will be recorded. Higher values indicate better lower-body flexibility.

  5. Back Scratch Test Performance

    Time frame: Baseline, 6 weeks, and 12 weeks after intervention start

    Upper-body flexibility will be assessed using the back scratch test. Participants will place one hand over the shoulder and the other behind the back, attempting to touch or overlap the middle fingers. The distance between the fingertips (positive score for overlap, negative for gap) will be recorded. Higher values indicate better upper-body flexibility.

  6. 8-Foot Up-and-Go Test Performance

    Time frame: Baseline, 6 weeks, and 12 weeks after intervention start

    Agility and dynamic balance will be assessed using the 8-foot up-and-go test. Participants will rise from a seated position, walk 8 feet, turn around, and return to sit down as quickly as possible. The total time taken (in seconds) will be recorded. Shorter times indicate better agility and dynamic balance.

Other outcomes

  1. Quality of life measured using the WHOQOL-BREF questionnaire

    Time frame: Baseline, 6 weeks, and 12 weeks after intervention start

    Quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire, which consists of 26 items covering four domains: physical health, psychological well-being, social relationships, and environment. Higher domain scores indicate better quality of life.

Sponsors and collaborators

Lead sponsor

University Malaysia Sarawak

Other

Registry information

Official study 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

Acronym: OEP

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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