FallsNCT01029171
Action Seniors! Exercise to Prevent Falls
A study testing Home-based balance and strength retraining exercise program. in people with Falls, run by University of British Columbia at 1 site in Canada.
Trial summary
This study will be a randomized controlled trial to determine the efficacy of the Otago Exercise Program (OEP) on falls among seniors with a history of falls. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Falls
- What is being tested?
- Home-based balance and strength retraining exercise program.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2009to Jul 2018
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Adults older than or 70 years attending a Falls Prevention Clinic Service;
- Understands, speaks, and reads English proficiently;
- MMSE 8 score > 24/30;
- Had one documented non-syncopal fall in the last 12 months and one of the following: a) A Physiological Profile Assessment (PPA) score of at least 1 SD above normal; OR 2) Timed Up and Go Test (TUG) performance of greater than 15 seconds; OR 3) One additional documented non-syncopal fall in the previous 12 months;
- Expected to live greater than 12 months;
- Community-dwelling (i.e., not residing in a nursing home, extended care unit, or assisted-care facility);
- Able to walk 3 meters with or without an assistive device; and
- Able to provide written informed consent.
Who cannot join
- Diagnosed with a neurodegenerative disease (e.g., Parkinson's disease);
- Diagnosed with dementia (of any type);
- Had a stroke;
- Have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease; or
- Have a history indicative of carotid sinus sensitivity (i.e., syncopal falls).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Aging, Mobility, and Cognitive Neuroscience Laboratory, Vancouver Falls Prevention Clinic, University of British Columbia
Vancouver, British Columbia
About this study
Official title: "Action Seniors!: A 12 Month Randomized Controlled Trial of a Home Based Strength and Balance Retraining Program in Reducing Falls.
This study will be a randomized controlled trial to determine the efficacy of the Otago Exercise Program (OEP) on falls among seniors with a history of falls.
Read the detailed description
A total of 344 community-dwelling adults aged 70 years and older who are referred to a falls clinic secondary to seeking medical attention due to a fall will be randomized to either the 12-month OEP group or usual care. There will be three measurement sessions: baseline, 6 months, and 12 months.
- Conditions
- Falls
- Being tested
- Home-based balance and strength retraining exercise program., control; usual care
- Keywords
- falls, balance training, strength training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based balance and strength retraining exercise program.Behavioural
A 12-month home-based balance and strength restraining program delivered by a physical therapist
control; usual careBehavioural
Usual care as prescribed by geriatrician.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | OEP (Otago Exercise Program; home-based balance and strength retraining program) Receives: Behavioral: Home-based balance and strength retraining exercise program. |
| 2 | Active comparator | CON (control; usual care) Receives: Behavioral: control; usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls over a 12 month period.
Measured: 12 months
Secondary outcomes (1)
Secondary outcomes of interest include: 1) physiological falls risk; 2) mobility; 3) cognitive function; and 4) economic evaluation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for FallsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Teresa Liu-Ambrose, University of British Columbia
- Investigators
- Teresa Liu-Ambrose, Principal investigator, University of British ColumbiaKarim Khan, Ph.D, Study director, University of British ColumbiaLarry Dian, MD, Study director, University of British ColumbiaWendy Cook, MD, Study director, University of British ColumbiaPenny Brasher, Ph.D, Study director, University of British ColumbiaCarlo Marra, Ph.D, Study director, University of British ColumbiaJennifer Davis, Ph.D, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029171
- Sponsor's protocol ID
- H04-70171
- Status last verified
- Oct 2018
- First submitted
- 7 Dec 2009
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Davis JC, Falck RS, Hsu CL, Khan K, Chan P, Ghag C, Jacova P, Madden K, Dian L, Rice J, Parmar N, Mitton C, Liu-Ambrose T. Using case-mixes to understand health resource utilization trajectories among older adults at high risk of falls who received baseline geriatrician-based Falls Prevention Clinic care. J Gerontol A Biol Sci Med Sci. 2026 Jun 6;81(7):glag146. doi: 10.1093/gerona/glag146.
PubMed 42226016Davis JC, Wiley E, Khan KM, Dian L, Madden K, Tai D, Hsu CL, Seo YS, Golbidi M, Liu-Ambrose T. Twelve-month cost analysis of a geriatrician-led falls prevention clinic in Canada. Maturitas. 2026 Apr;207:108862. doi: 10.1016/j.maturitas.2026.108862. Epub 2026 Feb 2.
PubMed 41722333Falck RS, Hsu CL, Davis JC, Rice J, Dao E, Dian L, Madden K, Skelton DA, Parmar N, Cook WL, Khan KM, Liu-Ambrose T. Effect of a home-based exercise program on subsequent falls among community-dwelling older adults with cognitive frailty: A sub-group analysis of a randomized controlled trial. Maturitas. 2025 Jan;191:108151. doi: 10.1016/j.maturitas.2024.108151. Epub 2024 Nov 7.
PubMed 39561465Davis JC, Hsu CL, Ghag C, Starkey SY, Jacova P, Dian L, Parmar N, Madden K, Liu-Ambrose T. Baseline health-related quality of life predicts falls: a secondary analysis of a randomized controlled trial. Qual Life Res. 2022 Nov;31(11):3211-3220. doi: 10.1007/s11136-022-03175-2. Epub 2022 Jul 7.
PubMed 35798988Davis JC, Hsu CL, Barha C, Jehu DA, Chan P, Ghag C, Jacova P, Adjetey C, Dian L, Parmar N, Madden K, Liu-Ambrose T. Comparing the cost-effectiveness of the Otago Exercise Programme among older women and men: A secondary analysis of a randomized controlled trial. PLoS One. 2022 Apr 20;17(4):e0267247. doi: 10.1371/journal.pone.0267247. eCollection 2022.
PubMed 35442974Liu-Ambrose T, Davis JC, Falck RS, Best JR, Dao E, Vesely K, Ghag C, Rosano C, Hsu CL, Dian L, Cook W, Madden KM, Khan KM. Exercise, Processing Speed, and Subsequent Falls: A Secondary Analysis of a 12-Month Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2021 Mar 31;76(4):675-682. doi: 10.1093/gerona/glaa239.
PubMed 33225343Davis JC, Khan KM, Hsu CL, Chan P, Cook WL, Dian L, Liu-Ambrose T. Action Seniors! Cost-Effectiveness Analysis of a Secondary Falls Prevention Strategy Among Community-Dwelling Older Fallers. J Am Geriatr Soc. 2020 Sep;68(9):1988-1997. doi: 10.1111/jgs.16476. Epub 2020 May 29.
PubMed 32472567Liu-Ambrose T, Davis JC, Best JR, Dian L, Madden K, Cook W, Hsu CL, Khan KM. Effect of a Home-Based Exercise Program on Subsequent Falls Among Community-Dwelling High-Risk Older Adults After a Fall: A Randomized Clinical Trial. JAMA. 2019 Jun 4;321(21):2092-2100. doi: 10.1001/jama.2019.5795.
PubMed 31162569Liu-Ambrose T, Davis JC, Hsu CL, Gomez C, Vertes K, Marra C, Brasher PM, Dao E, Khan KM, Cook W, Donaldson MG, Rhodes R, Dian L. Action seniors! - secondary falls prevention in community-dwelling senior fallers: study protocol for a randomized controlled trial. Trials. 2015 Apr 10;16:144. doi: 10.1186/s13063-015-0648-7.
PubMed 25873254
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Action Seniors!: A 12 Month Randomized Controlled Trial of a Home Based Strength and Balance Retraining Program in Reducing Falls.
- ClinicalTrials.gov ID
- NCT01029171
- Acronym / sponsor ID
- H04-70171
- Conditions
- Falls
- Keywords
- falls, balance training, strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Nov 2009
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 9 Dec 2009 (estimated)
- 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 study will be a randomized controlled trial to determine the efficacy of the Otago Exercise Program (OEP) on falls among seniors with a history of falls.
Detailed description
A total of 344 community-dwelling adults aged 70 years and older who are referred to a falls clinic secondary to seeking medical attention due to a fall will be randomized to either the 12-month OEP group or usual care. There will be three measurement sessions: baseline, 6 months, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Home-based balance and strength retraining exercise program.OEP (Otago Exercise Program; home-based balance and strength retraining program) |
| 2 | Active comparator | Behavioral: control; usual careCON (control; usual care) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Adults older than or 70 years attending a Falls Prevention Clinic Service;
- Understands, speaks, and reads English proficiently;
- MMSE 8 score > 24/30;
- Had one documented non-syncopal fall in the last 12 months and one of the following: a) A Physiological Profile Assessment (PPA) score of at least 1 SD above normal; OR 2) Timed Up and Go Test (TUG) performance of greater than 15 seconds; OR 3) One additional documented non-syncopal fall in the previous 12 months;
- Expected to live greater than 12 months;
Key exclusion criteria (5 listed)
- Diagnosed with a neurodegenerative disease (e.g., Parkinson's disease);
- Diagnosed with dementia (of any type);
- Had a stroke;
- Have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease; or
- Have a history indicative of carotid sinus sensitivity (i.e., syncopal falls).
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 |
|---|---|---|
| Home-based balance and strength retraining exercise program.A 12-month home-based balance and strength restraining program delivered by a physical therapist | Behavioural | 1 |
| control; usual careUsual care as prescribed by geriatrician. | Behavioural | 2 |
Primary outcome
Falls over a 12 month period.
Time frame: 12 months
1 secondary outcome
Secondary outcomes of interest include: 1) physiological falls risk; 2) mobility; 3) cognitive function; and 4) economic evaluation.
Time frame: 12 months
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 10 Oct 2018.
- Derived from this study: PubMed 42226016Davis JC, Falck RS, Hsu CL, Khan K, Chan P, Ghag C, Jacova P, Madden K, Dian L, Rice J, Parmar N, Mitton C, Liu-Ambrose T. Using case-mixes to understand health resource utilization trajectories among older adults at high risk of falls who received baseline geriatrician-based Falls Prevention Clinic care. J Gerontol A Biol Sci Med Sci. 2026 Jun 6;81(7):glag146. doi: 10.1093/gerona/glag146.
- Derived from this study: PubMed 41722333Davis JC, Wiley E, Khan KM, Dian L, Madden K, Tai D, Hsu CL, Seo YS, Golbidi M, Liu-Ambrose T. Twelve-month cost analysis of a geriatrician-led falls prevention clinic in Canada. Maturitas. 2026 Apr;207:108862. doi: 10.1016/j.maturitas.2026.108862. Epub 2026 Feb 2.
- Derived from this study: PubMed 39561465Falck RS, Hsu CL, Davis JC, Rice J, Dao E, Dian L, Madden K, Skelton DA, Parmar N, Cook WL, Khan KM, Liu-Ambrose T. Effect of a home-based exercise program on subsequent falls among community-dwelling older adults with cognitive frailty: A sub-group analysis of a randomized controlled trial. Maturitas. 2025 Jan;191:108151. doi: 10.1016/j.maturitas.2024.108151. Epub 2024 Nov 7.
- Derived from this study: PubMed 35798988Davis JC, Hsu CL, Ghag C, Starkey SY, Jacova P, Dian L, Parmar N, Madden K, Liu-Ambrose T. Baseline health-related quality of life predicts falls: a secondary analysis of a randomized controlled trial. Qual Life Res. 2022 Nov;31(11):3211-3220. doi: 10.1007/s11136-022-03175-2. Epub 2022 Jul 7.
- Derived from this study: PubMed 35442974Davis JC, Hsu CL, Barha C, Jehu DA, Chan P, Ghag C, Jacova P, Adjetey C, Dian L, Parmar N, Madden K, Liu-Ambrose T. Comparing the cost-effectiveness of the Otago Exercise Programme among older women and men: A secondary analysis of a randomized controlled trial. PLoS One. 2022 Apr 20;17(4):e0267247. doi: 10.1371/journal.pone.0267247. eCollection 2022.
- Derived from this study: PubMed 33225343Liu-Ambrose T, Davis JC, Falck RS, Best JR, Dao E, Vesely K, Ghag C, Rosano C, Hsu CL, Dian L, Cook W, Madden KM, Khan KM. Exercise, Processing Speed, and Subsequent Falls: A Secondary Analysis of a 12-Month Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2021 Mar 31;76(4):675-682. doi: 10.1093/gerona/glaa239.
- Derived from this study: PubMed 32472567Davis JC, Khan KM, Hsu CL, Chan P, Cook WL, Dian L, Liu-Ambrose T. Action Seniors! Cost-Effectiveness Analysis of a Secondary Falls Prevention Strategy Among Community-Dwelling Older Fallers. J Am Geriatr Soc. 2020 Sep;68(9):1988-1997. doi: 10.1111/jgs.16476. Epub 2020 May 29.
- Derived from this study: PubMed 31162569Liu-Ambrose T, Davis JC, Best JR, Dian L, Madden K, Cook W, Hsu CL, Khan KM. Effect of a Home-Based Exercise Program on Subsequent Falls Among Community-Dwelling High-Risk Older Adults After a Fall: A Randomized Clinical Trial. JAMA. 2019 Jun 4;321(21):2092-2100. doi: 10.1001/jama.2019.5795.
- Derived from this study: PubMed 25873254Liu-Ambrose T, Davis JC, Hsu CL, Gomez C, Vertes K, Marra C, Brasher PM, Dao E, Khan KM, Cook W, Donaldson MG, Rhodes R, Dian L. Action seniors! - secondary falls prevention in community-dwelling senior fallers: study protocol for a randomized controlled trial. Trials. 2015 Apr 10;16:144. doi: 10.1186/s13063-015-0648-7.
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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.
Teresa Liu-Ambrose principal investigator
University of British Columbia
Karim Khan, Ph.D study director
University of British Columbia
Larry Dian, MD study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based balance and strength retraining exercise program. in people with Falls, run by University of British Columbia at 1 site in Canada.
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 8 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 10 Oct 2018. 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 Canada. 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?
Falls over a 12 month period. (time frame: 12 months). 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 NCT01029171, which also lists 9 linked publications.
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 10 Oct 2018.