Physical PerformanceFREDANCT04788251
Falls Prevention Evaluation and Development for Older Adults in the Community
A study testing Exercise-based fall prevention intervention (Modified Otago Exercise Programme and Modified Stepping On Programme) in people with Physical Performance and Fear of Falling, run by Geriatric Education and Research Institute at 2 sites in Singapore.
Trial summary
Exercise-based fall prevention programmes with strength and balance components have been shown to reduce the rate of falls, risk of falling, fractures and injuries. However, there is little evidence on the implementation of these programmes in real-world settings. Read more about this study
- Who is it for?
- Ages 60 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Performance, Fear of Falling
- What is being tested?
- Exercise-based fall prevention intervention (Modified Otago Exercise Programme and Modified Stepping On Programme)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesSingapore
- Study dates
- 21 Sep 2021to 29 Oct 2022
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 60 years and above
- Lives in the community
- Living in the Central or North region of Singapore
- Singaporean or Singapore Permanent Resident
- Understand conversational English or Chinese
- Able to walk independently in the community with or without assistive devices (Defined as single-point walking aid, e.g. umbrella, cane, walking stick)
- Answered 'Yes' to any of 3 falls risk screening questions (i.e. 1. Did you have a fall in the past 12 months?, 2. Are you concerned about falling?, 3. Do you feel like you are going to fall when getting up or walking?)
Who cannot join
- Currently participating in other falls prevention programme or trial or participated in a fall prevention programme or trial in the past 3 months
- Has chest pains when doing exercise
- Had a recent major surgery less than 3 months or is undergoing renal dialysis or active cancer treatment
- Has been told by a doctor to have the following medical conditions: Dementia, Severe neuromuscular or cardiovascular conditions i.e. stroke in the past 6 months, heart failure, acute myocardial infarction, Parkinson's disease
- Have been told by a doctor not to exercise due to health issues
- Score of less than 7 on the Abbreviated Mental Test (AMT)
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Tan Tock Seng Hospital
Singapore, 308433
Khoo Teck Puat Hospital
Singapore, 768828
About this study
Exercise-based fall prevention programmes with strength and balance components have been shown to reduce the rate of falls, risk of falling, fractures and injuries. However, there is little evidence on the implementation of these programmes in real-world settings.
This study aims to assess the effectiveness of exercise-based fall prevention interventions on fall risk (physical performance and fear of falling) among community-dwelling older adults who are at risk of falling in Singapore. A secondary aim is to assess the effectiveness of the programme on other health outcomes. The study will also evaluate the programme implementation from 3 perspectives of older adults, implementers and community partners.
Read the detailed description
Two exercise-based fall prevention programmes (Otago Exercise Programme, OEP and the Stepping On Programme, SOP) have been shown to be effective to prevent and reduce falls in primarily non-Asian settings. The Otago Exercise Programme is a single component intervention that has been shown to reduce fall rate among older adults by 35%. The OEP is a group-based exercise programme based on strength and balance components. The Stepping-On Programme is a multi-component intervention that has been shown to reduce fall rate by 30%. The SOP consists of group-based series of weekly sessions to teach fall prevention strategies to community-dwelling older adults. Sessions comprise of strength-balance exercises and classes based on adult learning principles.
However, there is little evidence of the effectiveness, feasibility and acceptability of locally-adapted community fall prevention interventions. Furthermore, studies on the effectiveness of fall prevention interventions among Asian populations are less robust due to the lack of well-designed studies with adequately powered sample sizes.
In this study, exercise-based fall prevention programmes will be implemented based on geographic region where participants living in the North region will receive the modified SOP and participants in the Central region will receive the modified OEP.
- Conditions
- Physical Performance, Fear of Falling
- Being tested
- Exercise-based fall prevention intervention (Modified Otago Exercise Programme and Modified Stepping On Programme), Wait-list control
- Keywords
- Accidental fall, Older adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise-based fall prevention intervention (Modified Otago Exercise Programme and Modified Stepping On Programme)Other
The modified OEP is a group exercise programme that consists of progressive strength and balance exercises led by trained exercise leaders (fitness instructors or health coaches). The supervised sessions will be conducted twice a week (1 hour each) for 7 weeks. Participants will be given an exercise booklet and encouraged to exercise at home.
The modified SOP is a group fall prevention programme that consists of exercise sessions and discussions on various falls prevention aspects facilitated by a trained programme leader and supported by programme facilitators and peer facilitators. The supervised sessions will be conducted once a week (2 hours each) for 7 weeks. Participants will be given homework and encouraged to exercise at home. In addition, there will be an optional home visit (Week 11), a 1-hour booster session (Week 19) and a telephone call (Week 31).
Wait-list controlOther
To receive fall prevention resources while waiting for their programme to start
| Study group | Role | What they receive |
|---|---|---|
| Exercise-based fall prevention intervention | Experimental | To receive 7 weeks of exercise-based programme Receives: Other: Exercise-based fall prevention intervention (Modified Otago Exercise Programme and Modified Stepping On Programme) |
| Wait-list controls | Other | To receive fall prevention resources while waiting for programme Receives: Other: Wait-list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Mobility Between Intervention and Control Blocks
Measured using the Timed Up and Go (TUG)
Measured: Data will be collected at baseline and immediately after each step as this is a stepped-wedge analysis.
Secondary outcomes (2)
Difference in Physical Performance Between Intervention and Control Blocks
Measured using the Short Physical Performance Battery (SPPB). A summary score (range 0-12) will be calculated, with higher score indicating a better performance.
Measured: Data will be collected at baseline and immediately after each step as this is a stepped-wedge analysis.
Difference in Fear of Falling Between Intervention and Control Blocks
Measured using the 16-item Falls Efficacy Scale International (FES-I). The score ranges from 16 to 64, with a higher score indicating a greater fear of falling.
Measured: Data will be collected at baseline and immediately after each step as this is a stepped-wedge analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start21 Sep 2021
- Primary completion29 Oct 2022
- Study completion29 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical PerformanceStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a stepped-wedge cluster randomized trial in which there will be a sequential crossover of clusters from the waitlist control to the intervention period where the sequence of crossover is randomized. The clusters are defined as groups with at least 5 participants. Each of the North and Central regions will have 6 clusters. The intervention will be sequentially rolled out to 12 clusters that are randomized to 6 time periods (sequences). Each sequence has 6 steps where one step has a duration of 8 weeks. The intervention will be rolled out sequentially to 2 clusters (1 North, 1 Central) at every step until all 12 clusters have received the intervention by the end of the study. Each cluster will have 1-3 community sites and minimum 5 participants. Outcome assessors will be blinded to sequence allocation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geriatric Education and Research Institute
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, Singapore, Tan Tock Seng Hospital, Khoo Teck Puat Hospital, Singapore Institute of Technology, Duke-NUS Graduate Medical School, Monash University
- Responsible party
- Sponsor
- Investigators
- Chek Hooi Wong, MBBS, FRCP, MPH, Principal investigator, Geriatric Education and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788251
- Sponsor's protocol ID
- 2020/01193
- Acronym
- FREDA
- Status last verified
- May 2023
- First submitted
- 19 Jan 2021
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tan PJ, Ginting ML, Lim ZZB, Balachandar N, Sultana R, Kadir MM, Xu T, Ismail NH, Yap JKY, Wong SF, Yoong J, Matchar DB, Hill K, Wong CH. Pragmatic multicentre stepped-wedge cluster randomised trial to investigate the effectiveness of community-based falls prevention programme for older adults with falls risk in Singapore: a protocol paper. BMJ Open. 2023 Jun 1;13(6):e072029. doi: 10.1136/bmjopen-2023-072029.
PubMed 37263684
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Falls Prevention Evaluation and Development for Older Adults in the Community
- ClinicalTrials.gov ID
- NCT04788251
- Acronym / sponsor ID
- FREDA / 2020/01193
- Conditions
- Physical Performance, Fear of Falling
- Keywords
- Accidental fall, Older adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Geriatric Education and Research InstituteOther government
- Collaborators
- Ministry of Health, Singapore, Tan Tock Seng Hospital, Khoo Teck Puat Hospital, Singapore Institute of Technology, Duke-NUS Graduate Medical School, Monash University
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 29 Oct 2022 (actual)
- Study completion
- 29 Oct 2022 (actual)
- First posted
- 9 Mar 2021 (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.
Exercise-based fall prevention programmes with strength and balance components have been shown to reduce the rate of falls, risk of falling, fractures and injuries. However, there is little evidence on the implementation of these programmes in real-world settings.
This study aims to assess the effectiveness of exercise-based fall prevention interventions on fall risk (physical performance and fear of falling) among community-dwelling older adults who are at risk of falling in Singapore. A secondary aim is to assess the effectiveness of the programme on other health outcomes. The study will also evaluate the programme implementation from 3 perspectives of older adults, implementers and community partners.
Detailed description
Two exercise-based fall prevention programmes (Otago Exercise Programme, OEP and the Stepping On Programme, SOP) have been shown to be effective to prevent and reduce falls in primarily non-Asian settings. The Otago Exercise Programme is a single component intervention that has been shown to reduce fall rate among older adults by 35%. The OEP is a group-based exercise programme based on strength and balance components. The Stepping-On Programme is a multi-component intervention that has been shown to reduce fall rate by 30%. The SOP consists of group-based series of weekly sessions to teach fall prevention strategies to community-dwelling older adults. Sessions comprise of strength-balance exercises and classes based on adult learning principles.
However, there is little evidence of the effectiveness, feasibility and acceptability of locally-adapted community fall prevention interventions. Furthermore, studies on the effectiveness of fall prevention interventions among Asian populations are less robust due to the lack of well-designed studies with adequately powered sample sizes.
In this study, exercise-based fall prevention programmes will be implemented based on geographic region where participants living in the North region will receive the modified SOP and participants in the Central region will receive the modified OEP.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a stepped-wedge cluster randomized trial in which there will be a sequential crossover of clusters from the waitlist control to the intervention period where the sequence of crossover is randomized. The clusters are defined as groups with at least 5 participants. Each of the North and Central regions will have 6 clusters. The intervention will be sequentially rolled out to 12 clusters that are randomized to 6 time periods (sequences). Each sequence has 6 steps where one step has a duration of 8 weeks. The intervention will be rolled out sequentially to 2 clusters (1 North, 1 Central) at every step until all 12 clusters have received the intervention by the end of the study. Each cluster will have 1-3 community sites and minimum 5 participants. Outcome assessors will be blinded to sequence allocation.
| Arm | Type | Receives |
|---|---|---|
| Exercise-based fall prevention intervention | Experimental | Other: Exercise-based fall prevention intervention (Modified Otago Exercise Programme and Modified Stepping On Programme)To receive 7 weeks of exercise-based programme |
| Wait-list controls | Other | Other: Wait-list controlTo receive fall prevention resources while waiting for programme |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 60 years and above
- Lives in the community
- Living in the Central or North region of Singapore
- Singaporean or Singapore Permanent Resident
- Understand conversational English or Chinese
Key exclusion criteria (6 listed)
- Currently participating in other falls prevention programme or trial or participated in a fall prevention programme or trial in the past 3 months
- Has chest pains when doing exercise
- Had a recent major surgery less than 3 months or is undergoing renal dialysis or active cancer treatment
- Has been told by a doctor to have the following medical conditions: Dementia, Severe neuromuscular or cardiovascular conditions i.e. stroke in the past 6 months, heart failure, acute myocardial infarction, Parkinson's disease
- Have been told by a doctor not to exercise due to health issues
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 |
|---|---|---|
| Exercise-based fall prevention intervention (Modified Otago Exercise Programme and Modified Stepping On Programme)The modified OEP is a group exercise programme that consists of progressive strength and balance exercises led by trained exercise leaders (fitness instructors or health coaches). The supervised sessions will be conducted twice a week (1 hour each) for 7 weeks. Participants will be given an exercise booklet and encouraged to exercise at home. The modified SOP is a group fall prevention programme that consists of exercise sessions and discussions on various falls prevention aspects facilitated by a trained programme leader and supported by programme facilitators and peer facilitators. The supervised sessions will be conducted once a week (2 hours each) for 7 weeks. Participants will be given homework and encouraged to exercise at home. In addition, there will be an optional home visit (Week 11), a 1-hour booster session (Week 19) and a telephone call (Week 31). | Other | Exercise-based fall prevention intervention |
| Wait-list controlTo receive fall prevention resources while waiting for their programme to start | Other | Wait-list controls |
Primary outcome
Difference in Mobility Between Intervention and Control Blocks
Time frame: Data will be collected at baseline and immediately after each step as this is a stepped-wedge analysis.
Measured using the Timed Up and Go (TUG)
2 secondary outcomes
Difference in Physical Performance Between Intervention and Control Blocks
Time frame: Data will be collected at baseline and immediately after each step as this is a stepped-wedge analysis.
Difference in Fear of Falling Between Intervention and Control Blocks
Time frame: Data will be collected at baseline and immediately after each step as this is a stepped-wedge analysis.
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 6 May 2023.
- Derived from this study: PubMed 37263684Tan PJ, Ginting ML, Lim ZZB, Balachandar N, Sultana R, Kadir MM, Xu T, Ismail NH, Yap JKY, Wong SF, Yoong J, Matchar DB, Hill K, Wong CH. Pragmatic multicentre stepped-wedge cluster randomised trial to investigate the effectiveness of community-based falls prevention programme for older adults with falls risk in Singapore: a protocol paper. BMJ Open. 2023 Jun 1;13(6):e072029. doi: 10.1136/bmjopen-2023-072029.
- Individual participant dataSharing planned: No
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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.
Chek Hooi Wong, MBBS, FRCP, MPH principal investigator
Geriatric Education and Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise-based fall prevention intervention (Modified Otago Exercise Programme and Modified Stepping On Programme) in people with Physical Performance and Fear of Falling, run by Geriatric Education and Research Institute at 2 sites in Singapore.
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 7 inclusion and 6 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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?
Difference in Mobility Between Intervention and Control Blocks (time frame: Data will be collected at baseline and immediately after each step as this is a stepped-wedge analysis.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04788251, which also lists 1 linked publication.
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 6 May 2023.