Accidental FallsOEPNCT07258550
Otago Exercise Programme and Physical Function in Older Adults in Sarawak
A study testing Otago Exercise Programme (OEP) in people with Accidental Falls and Balance Assessment, run by University Malaysia Sarawak at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls, Balance Assessment, Physical Fitness
- What is being tested?
- Otago Exercise Programme (OEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Apr 2024to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Accidental Falls, Balance Assessment, Physical Fitness
- Being tested
- Otago Exercise Programme (OEP)
- Keywords
- Otago Exercise Programme, Balance, Physical fitness, Quality of life, Older adults, Sarawak, Fall prevention, Community-dwelling elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago Exercise Programme (OEP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks, and 12 weeks after intervention start
Secondary outcomes (6)
30-Second Chair Stand Test Performance
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.
Measured: Baseline, 6 weeks, and 12 weeks after intervention start
Arm Curl Test Performance
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.
Measured: Baseline, 6 weeks, and 12 weeks after intervention start
2-Minute Step Test Performance
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.
Measured: Baseline, 6 weeks, and 12 weeks after intervention start
Chair Sit-and-Reach Test Performance
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.
Measured: Baseline, 6 weeks, and 12 weeks after intervention start
Back Scratch Test Performance
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.
Measured: Baseline, 6 weeks, and 12 weeks after intervention start
8-Foot Up-and-Go Test Performance
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.
Measured: Baseline, 6 weeks, and 12 weeks after intervention start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Apr 2024
- Primary completion30 Jun 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Malaysia Sarawak
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anselm Ting Su, University Malaysia Sarawak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258550
- Sponsor's protocol ID
- UNIMAS-OEP-2024
- Other IDs
- SELF-FUNDED-DRPH-2024
- Acronym
- OEP
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the dataset contains identifiable information related to community-dwelling older adults in Sarawak. Data access is restricted under the Universiti Malaysia Sarawak (UNIMAS) Medical Ethics Committee approval. Only aggregated or anonymized results will be available upon reasonable request to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07258550
- Acronym / sponsor ID
- OEP / UNIMAS-OEP-2024
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Malaysia SarawakUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Otago Exercise Programme (OEP) | Experimental | Behavioral: 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. |
| 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. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Experimental: Otago Exercise Programme (OEP) |
Primary outcome
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.
6 secondary outcomes
30-Second Chair Stand Test Performance
Time frame: Baseline, 6 weeks, and 12 weeks after intervention start
Arm Curl Test Performance
Time frame: Baseline, 6 weeks, and 12 weeks after intervention start
2-Minute Step Test Performance
Time frame: Baseline, 6 weeks, and 12 weeks after intervention start
Chair Sit-and-Reach Test Performance
Time frame: Baseline, 6 weeks, and 12 weeks after intervention start
Back Scratch Test Performance
Time frame: Baseline, 6 weeks, and 12 weeks after intervention start
8-Foot Up-and-Go Test Performance
Time frame: Baseline, 6 weeks, and 12 weeks after intervention start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the dataset contains identifiable information related to community-dwelling older adults in Sarawak. Data access is restricted under the Universiti Malaysia Sarawak (UNIMAS) Medical Ethics Committee approval. Only aggregated or anonymized results will be available upon reasonable request to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otago Exercise Programme (OEP) in people with Accidental Falls and Balance Assessment, run by University Malaysia Sarawak at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance performance measured using the Berg Balance Scale (BBS) (time frame: Baseline, 6 weeks, and 12 weeks after intervention start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.