FallsACTIVENCT06854731
Preventing Falls in Older Adults With Cognitive Frailty
A study testing Balance and Strength Training Exercises with Health Coaching and Education Session in people with Falls and Frailty, run by University of British Columbia at 1 site in Canada.
Trial summary
The Problem: The proposed trial will address the problem of how to effectively prevent subsequent falls in community-dwelling cognitively frail older adults with a history of falls. Read more about this study
- Who is it for?
- Ages 65 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Falls, Frailty, Mild Cognitive Impairment
- What is being tested?
- Balance and Strength Training Exercises with Health Coaching and Education Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 siteCanada
- Study dates
- 15 May 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 to 89 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- We will include individuals who meet the following criteria: 1) aged between 65 and 89 years; 2) live in Greater Vancouver, British Columbia; 3) are community-dwelling (i.e., not residing in a nursing home or extended care unit); 4) experienced a non-syncopal fall in the prior 12 months; 5) scored ≤ 9/12 on the SPPB; 6) have subjective cognitive impairment based on interview; 7) scored 18-25/30 on the MoCA [62,64]; 8) are able to walk with or without a gait aid; 9) scored ≥ 6/8 on Lawton and Brody Instrumental Activities of Daily Living Scale (IADL) [65]; 10) are able to safely engage in exercise as indicated by the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) [66]; and 11) are able to understand, speak, and read English with sufficient proficiency to complete the assessments.
- The age maximum of 89 was set due to the increased risk of significant adverse health outcomes cognitively frail older adults face. As this population has an increased risk of falls, functional disability with loss of independence, hospitalization, and death, setting an age maximum aims to increase the likelihood that participants will be able to complete the 18-month study without interruptions due to health complications. This age limit has been reviewed and approved by CIHR.
Who cannot join
- We will exclude individuals who: 1) have been diagnosed with dementia, a neurodegenerative disease, or stroke; 2) report engaging in strength and balance training exercises ≥ 2 times per week in the prior 3 months; 3) have severe depression based on a score of ≥ 11/15 on the GDS.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre for Aging SMART at VCH, University of BC
Vancouver, British Columbia, V5Z1M9
About this study
Official title: ACTIVE: Adding Life to Years in Cognitive Frailty by Preventing Falls
The Problem: The proposed trial will address the problem of how to effectively prevent subsequent falls in community-dwelling cognitively frail older adults with a history of falls.
Primary Question: In community-dwelling older adults with cognitive frailty and a history of falls, can a home-based exercise program with behavioural change techniques significantly reduce falls vs. health education (i.e., control; CON)?
Read the detailed description
Rationale: Falls are a significant cause of functional decline and often a sentinel event. Older adults with cognitive frailty - those with concurrent physical frailty and mild cognitive impairment - are at particular risk for falls. Notably, falls can cause a sudden and severe change in their health state from one of independence to one of dependence. Thus, effective falls prevention strategies need to be identified for older adults with cognitive frailty.
The Otago Exercise Program (OEP) - a physical therapist (PT) delivered home-based exercise program - is an evidence-based falls prevention program for community-dwelling older adults. Our pilot data show the OEP vs. usually care significantly reduced subsequent falls in 192 community-dwelling older adults with cognitive frailty and a history of falls; the incident rate ratio was 0.64 (95% CI, 0.43-0.98; P = .042). These preliminary findings need to be confirmed in a rigorously designed RCT powered for falls in older adults with cognitive frailty; none exist to date.
We also observed lower OEP adherence among older adults with cognitive frailty vs. those without cognitive frailty. Thus, strategies to support adherence must be considered in RCTs of exercise to prevent falls in this high-risk population. Evidence-based strategies include health coaching.
Thus, we propose a 12-month multi-site randomized controlled trial (RCT) in older adults with cognitive frailty and a history of falls to assess the efficacy of the OEP combined with health coaching (i.e., OEP+) to prevent falls.
Primary Question: In community-dwelling older adults with cognitive frailty and a history of falls, can the OEP+ significantly reduce falls vs. health education (i.e., control; CON)?
Secondary Questions: 1) What are additional benefits of the OEP+ vs. CON? 2) Do the benefits of OEP+ persist 6 months post cessation? 3) Can the OEP+ reduce falls or improve quality of life at similar or lower costs vs. CON?
Methods: A 12-month assessor-blinded, multi-site RCT, with a 6-month follow-up, in older adults, with cognitive frailty - defined by a Short Physical Performance Battery score <= 9/12 and a Montreal Cognitive Assessment score between 18-25/30 - and a history of falls. Participants will be randomized to either: a) OEP+ or b) CON. The OEP+ intervention will include Brief Action Planning-based health coaching. The CON group will include monthly interactive education sessions via Zoom. Measurement will occur at baseline, 6, 12, and 18 months, with falls tracked daily.
- Conditions
- Falls, Frailty, Mild Cognitive Impairment
- Being tested
- Balance and Strength Training Exercises with Health Coaching, Education Session
- Keywords
- execise, falls, cognitive frailty
- Medical subject headings
- Frailty, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance and Strength Training Exercises with Health CoachingBehavioural
Also called Otago Exercise Program Plus (OEP+)
The OEP+ intervention integrates the OEP with health coaching by a physical therapists or kinesiologist. The OEP is an individualized home-based balance and strength exercise training program delivered by a PT or kinesiologist coach over 5 home visits.
Education SessionOther
All active comparator participants will be invited to join monthly interactive social and education sessions via Zoom or in-person (hybrid delivery).
| Study group | Role | What they receive |
|---|---|---|
| Educational Control | Active comparator | All active control participants will be invited to join monthly interactive education sessions via Zoom or in-person. Receives: Other: Education Session |
| Otago Exercise Program (OEP) Plus | Experimental | The OEP+ intervention integrates the OEP with health coaching by a physical therapist or kinesiologist. The OEP is an individualized home-based balance and strength exercise training program delivered by a PT or kinesiologist coach over 5 home visits and 6 phone check-ins Receives: Behavioral: Balance and Strength Training Exercises with Health Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls
The number of self-reported falls during the 12-month intervention period (i.e., rate of falls).
Measured: Daily tracking over 12 months
Secondary outcomes (21)
Short Physical Performance Battery
A physical performance battery out of 12 points (max. performance).
Measured: Baseline, 6 months, 12 months, 18 months
Montreal Cognitive Assessment
A test that covers multiple cognitive domains. Often used to screen for mild cognitive impairment.
Measured: Baseline, 6 months, 12 months, 18 months
Falls during followup period
The number of self-reported falls during the 6-month ifollowup period (i.e., rate of falls).
Measured: Daily tracking from 12 months (trial completion) to end of 6-month followup (18 months)
NIH Cognitive Toolbox
Cognitive function measured using the NIH Cognitive Toolbox: Dimensional Change Card Sort Test and Flanker Inhibitory Control and Attention Test
Measured: Baseline, 6 months, 12 months, 18 months
Processing speed
Processing speed measured by Digit Symbol Substitution Test
Measured: Baseline, 6 months, 12 months, 18 months
Memory
Memory measured by the Rey Auditory Verbal Learning Test
Measured: Baseline, 6 months, 12 months, 18 months
Gait Speed
Walking speed in m/s measured over 4 meters (part of the Short Physical Performance Battery)
Measured: Baseline, 6 months, 12 months, 18 months
Muscle Strength
Dominant quadriceps strength and dominant hand grip strength.
Measured: Baseline, 6 months, 12 months, 18 months
Community Mobility
Life Space Questionnaire to measure community mobility
Measured: Baseline, 6 months, 12 months, 18 months
Functional Mobility
Timed Up and Go Test to measure functional mobility
Measured: Baseline, 6 months, 12 months, 18 months
Fatigue
The 9-item Fatigue Severity Scale will be used to assess how fatigue interferes with certain activities and its severity.
Measured: Baseline, 6 months, 12 months, 18 months
Quality of Life
The EuroQol EQ-5 Domain (5D)-5 Level (5L) (EQ-5D-5L) and the EuroQol Visual Analogue Scale (EQ-VAS) will assess quality of life
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months
Fear of Falling
Fear of falling as assessed by the Iconographical Falls Efficacy Scale (Icon-FES).
Measured: Baseline, 6 months, 12 months, 18 months
Health Resource Utilization (HRU)
Cost data will be collected every 3 months using the HRU questionnaire
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months
Sleep Quality (Objective) - Optional
Sleep quality parameters will be measured using ActiGraph
Measured: Baseline, 6 months, 12 months, 18 months
Brain Function - Optional
Brain function will be measured using functional near-infrared spectroscopy
Measured: Baseline, 6 months, 12 months
Physical Frailty
The Short Physical Performance Battery (physical performance battery out of 12 points (max. performance) and the Fried Frailty Phenotype (scores range from 0-5 where 0 is characterized as non-frail, 1-2 as pre-frail and >=3 as frail)
Measured: Baseline, 6 months, 12 months, 18 months
Physical Activity
The Physical Activity Scale for the Elderly (PASE) will be used to measure physical activity levels. PASE is a 12-item scale.
Measured: Baseline, 6 months, 12 months, 18 months
Mood
15-item Geriatric Depression Scale (GDS) will be used to assess depressive symptoms. GDS score of >=11/15 is suggestive of severe depression
Measured: Baseline, 6 months, 12 months, 18 months
Fall Risk
Fall risk is assessed by the Physiological Profile Assessment (PPA). A PPA z-score of 0-1 is indicative of mild fall risk, 1-2 indicates moderate risk, 2-3 indicates high risk, and > 3 indicates marked risk
Measured: Baseline, 6 months, 12 months, 18 months
Frailty Index
A frailty index will be calculated based on an accumulation of deficits across multiple domains and constructed using our primary and secondary outcome measures.
Measured: Baseline, 6 months, 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start15 May 2025
- Primary completion1 May 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute
- Responsible party
- Principal investigator, Teresa Liu-Ambrose, University of British Columbia
- Investigators
- Teresa Liu-Ambrose, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854731
- Sponsor's protocol ID
- H23-01584
- Acronym
- ACTIVE
- Status last verified
- Aug 2026
- First submitted
- 17 Feb 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACTIVE: Adding Life to Years in Cognitive Frailty by Preventing Falls
- ClinicalTrials.gov ID
- NCT06854731
- Acronym / sponsor ID
- ACTIVE / H23-01584
- Conditions
- Falls, Frailty, Mild Cognitive Impairment
- Keywords
- execise, falls, cognitive frailty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute
- Study start
- 15 May 2025 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Mar 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.
The Problem: The proposed trial will address the problem of how to effectively prevent subsequent falls in community-dwelling cognitively frail older adults with a history of falls.
Primary Question: In community-dwelling older adults with cognitive frailty and a history of falls, can a home-based exercise program with behavioural change techniques significantly reduce falls vs. health education (i.e., control; CON)?
Detailed description
Rationale: Falls are a significant cause of functional decline and often a sentinel event. Older adults with cognitive frailty - those with concurrent physical frailty and mild cognitive impairment - are at particular risk for falls. Notably, falls can cause a sudden and severe change in their health state from one of independence to one of dependence. Thus, effective falls prevention strategies need to be identified for older adults with cognitive frailty.
The Otago Exercise Program (OEP) - a physical therapist (PT) delivered home-based exercise program - is an evidence-based falls prevention program for community-dwelling older adults. Our pilot data show the OEP vs. usually care significantly reduced subsequent falls in 192 community-dwelling older adults with cognitive frailty and a history of falls; the incident rate ratio was 0.64 (95% CI, 0.43-0.98; P = .042). These preliminary findings need to be confirmed in a rigorously designed RCT powered for falls in older adults with cognitive frailty; none exist to date.
We also observed lower OEP adherence among older adults with cognitive frailty vs. those without cognitive frailty. Thus, strategies to support adherence must be considered in RCTs of exercise to prevent falls in this high-risk population. Evidence-based strategies include health coaching.
Thus, we propose a 12-month multi-site randomized controlled trial (RCT) in older adults with cognitive frailty and a history of falls to assess the efficacy of the OEP combined with health coaching (i.e., OEP+) to prevent falls.
Primary Question: In community-dwelling older adults with cognitive frailty and a history of falls, can the OEP+ significantly reduce falls vs. health education (i.e., control; CON)?
Secondary Questions: 1) What are additional benefits of the OEP+ vs. CON? 2) Do the benefits of OEP+ persist 6 months post cessation? 3) Can the OEP+ reduce falls or improve quality of life at similar or lower costs vs. CON?
Methods: A 12-month assessor-blinded, multi-site RCT, with a 6-month follow-up, in older adults, with cognitive frailty - defined by a Short Physical Performance Battery score <= 9/12 and a Montreal Cognitive Assessment score between 18-25/30 - and a history of falls. Participants will be randomized to either: a) OEP+ or b) CON. The OEP+ intervention will include Brief Action Planning-based health coaching. The CON group will include monthly interactive education sessions via Zoom. Measurement will occur at baseline, 6, 12, and 18 months, with falls tracked daily.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Control | Active comparator | Other: Education SessionAll active control participants will be invited to join monthly interactive education sessions via Zoom or in-person. |
| Otago Exercise Program (OEP) Plus | Experimental | Behavioral: Balance and Strength Training Exercises with Health CoachingThe OEP+ intervention integrates the OEP with health coaching by a physical therapist or kinesiologist. The OEP is an individualized home-based balance and strength exercise training program delivered by a PT or kinesiologist coach over 5 home visits and 6 phone check-ins |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- We will include individuals who meet the following criteria: 1) aged between 65 and 89 years; 2) live in Greater Vancouver, British Columbia; 3) are community-dwelling (i.e., not residing in a nursing home or extended care unit); 4) experienced a non-syncopal fall in the prior 12 months; 5) scored ≤ 9/12 on the SPPB; 6) have subjective cognitive impairment based on interview; 7) scored 18-25/30 on the MoCA [62,64]; 8) are able to walk with or without a gait aid; 9) scored ≥ 6/8 on Lawton and Brody Instrumental Activities of Daily Living Scale (IADL) [65]; 10) are able to safely engage in exercise as indicated by the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) [66]; and 11) are able to understand, speak, and read English with sufficient proficiency to complete the assessments.
- The age maximum of 89 was set due to the increased risk of significant adverse health outcomes cognitively frail older adults face. As this population has an increased risk of falls, functional disability with loss of independence, hospitalization, and death, setting an age maximum aims to increase the likelihood that participants will be able to complete the 18-month study without interruptions due to health complications. This age limit has been reviewed and approved by CIHR.
Key exclusion criteria (1 listed)
- We will exclude individuals who: 1) have been diagnosed with dementia, a neurodegenerative disease, or stroke; 2) report engaging in strength and balance training exercises ≥ 2 times per week in the prior 3 months; 3) have severe depression based on a score of ≥ 11/15 on the GDS.
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 |
|---|---|---|
| Balance and Strength Training Exercises with Health CoachingAlso: Otago Exercise Program Plus (OEP+)The OEP+ intervention integrates the OEP with health coaching by a physical therapists or kinesiologist. The OEP is an individualized home-based balance and strength exercise training program delivered by a PT or kinesiologist coach over 5 home visits. | Behavioural | Otago Exercise Program (OEP) Plus |
| Education SessionAll active comparator participants will be invited to join monthly interactive social and education sessions via Zoom or in-person (hybrid delivery). | Other | Educational Control |
Primary outcome
Falls
Time frame: Daily tracking over 12 months
The number of self-reported falls during the 12-month intervention period (i.e., rate of falls).
21 secondary outcomes
Short Physical Performance Battery
Time frame: Baseline, 6 months, 12 months, 18 months
Montreal Cognitive Assessment
Time frame: Baseline, 6 months, 12 months, 18 months
Falls during followup period
Time frame: Daily tracking from 12 months (trial completion) to end of 6-month followup (18 months)
NIH Cognitive Toolbox
Time frame: Baseline, 6 months, 12 months, 18 months
Processing speed
Time frame: Baseline, 6 months, 12 months, 18 months
Memory
Time frame: Baseline, 6 months, 12 months, 18 months
Gait Speed
Time frame: Baseline, 6 months, 12 months, 18 months
Muscle Strength
Time frame: Baseline, 6 months, 12 months, 18 months
Community Mobility
Time frame: Baseline, 6 months, 12 months, 18 months
Functional Mobility
Time frame: Baseline, 6 months, 12 months, 18 months
Fatigue
Time frame: Baseline, 6 months, 12 months, 18 months
Quality of Life
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months
Fear of Falling
Time frame: Baseline, 6 months, 12 months, 18 months
Health Resource Utilization (HRU)
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months
Sleep Quality (Objective) - Optional
Time frame: Baseline, 6 months, 12 months, 18 months
Brain Function - Optional
Time frame: Baseline, 6 months, 12 months
Physical Frailty
Time frame: Baseline, 6 months, 12 months, 18 months
Physical Activity
Time frame: Baseline, 6 months, 12 months, 18 months
Mood
Time frame: Baseline, 6 months, 12 months, 18 months
Fall Risk
Time frame: Baseline, 6 months, 12 months, 18 months
Frailty Index
Time frame: Baseline, 6 months, 12 months, 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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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.
Teresa Liu-Ambrose, PhD principal investigator
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 Balance and Strength Training Exercises with Health Coaching and Education Session in people with Falls and Frailty, 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teresa Liu-Ambrose, PhD (6046178047, teresa.ambrose@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Falls (time frame: Daily tracking over 12 months). 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 9 Sep 2026.