Effects of the Otago Exercise Programme on Senior Physical Fitness, Balance, and Quality of Life Among Older Adults in Sarawak: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Balance performance measured using the Berg Balance Scale (BBS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Balance performance measured using the Berg Balance Scale (BBS)
时间窗: 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.
次要结局
- 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)
- Back Scratch 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)
- 8-Foot Up-and-Go Test Performance(Baseline, 6 weeks, and 12 weeks after intervention start)
研究者
Anselm Ting Su
Professor, Faculty of Medicine & Health Sciences, Universiti Malaysia Sarawak (UNIMAS)
University Malaysia Sarawak