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NCT Number: NCT06854731

Preventing Falls in Older Adults With Cognitive Frailty

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)?

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Key information

Age range

65 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Aging SMART at VCH, University of BC

Vancouver, British Columbia, V5Z1M9, Canada

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • We will include individuals who: 1) are aged 70 to 89 years*; 2) live in Greater Vancouver; 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 complaints based on interview; 7) scored 18-25/30 on the MoCA; 8) are able to walk independently; use of cane is acceptable; 9) are able to safely engage in exercise as indicated by the Physical Activity Readiness Questionnaire Plus (PAR-Q+) and confirmed by their physician; 10) have internet at home; and 11) are able to provide written informed consent.
  • 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.

Exclusion criteria

  • We will exclude those who are: 1) diagnosed with dementia, as measured by a Clinical Dementia Rating (CDR) score above 0.5, a neurodegenerative disease, or stroke; 2) self-report engaging in strength training and/or balance training exercises > 2 times per week, in the prior 3 months; or 3) unable to understand, speak, and read English proficiently.

Treatment and study plan

Balance and Strength Training Exercises with Health Coaching

Behavioral

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.

Other names: Otago Exercise Program Plus (OEP+)

Education Session

Other

All active comparator participants will be invited to join monthly interactive social and education sessions via Zoom or in-person (hybrid delivery).

Primary outcomes

  1. 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).

Secondary outcomes

  1. Short Physical Performance Battery

    Time frame: Baseline, 6 months, 12 months, 18 months

    A physical performance battery out of 12 points (max. performance).

  2. Montreal Cognitive Assessment

    Time frame: Baseline, 6 months, 12 months, 18 months

    A test that covers multiple cognitive domains. Often used to screen for mild cognitive impairment.

  3. Falls during followup period

    Time frame: Daily tracking from 12 months (trial completion) to end of 6-month followup (18 months)

    The number of self-reported falls during the 6-month ifollowup period (i.e., rate of falls).

  4. NIH Cognitive Toolbox

    Time frame: Baseline, 6 months, 12 months, 18 months

    Cognitive function measured using the NIH Cognitive Toolbox

  5. Processing speed

    Time frame: Baseline, 6 months, 12 months, 18 months

    Processing speed measured by Digit Symbol Substitute Test

  6. Memory

    Time frame: Baseline, 6 months, 12 months, 18 months

    Memory measured by the Rey Auditory Verbal Learning Test

  7. Gait Speed

    Time frame: Baseline, 6 months, 12 months, 18 months

    Walking speed in m/s measured over 4 meters (part of the Short Physical Performance Battery)

  8. Muscle Strength

    Time frame: Baseline, 6 months, 12 months, 18 months

    Dominant quadriceps strength and dominant hand grip strength.

  9. Community Mobility

    Time frame: Baseline, 6 months, 12 months, 18 months

    Life Space Questionnaire to measure community mobility

  10. Functional Mobility

    Time frame: Baseline, 6 months, 12 months, 18 months

    Timed Up and Go Test to measure functional mobility

  11. Fatigue

    Time frame: Baseline, 6 months, 12 months, 18 months

    The 9-item Fatigue Severity Scale100 will be used to assess how fatigue interferes with certain activities and its severity.

  12. Quality of Life

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months

    The EuroQol EQ-5 Domain (5D)-5 Level (5L) (EQ-5D-5L) will assess quality of life

  13. Fear of Falling

    Time frame: Baseline, 6 months, 12 months, 18 months

    Fear of falling as assessed by the Iconographical Falls Efficacy Scale (Icon-FES).

  14. Health Resource Utilization (HRU)

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months

    Cost data will be collected every 3 months using the HRU questionnaire

  15. Sleep Quality (Subjective)

    Time frame: Baseline, 6 months, 12 months, 18 months

    Sleep quality will be measured subjectively using the Pittsburgh Quality Sleep Index

  16. Sleep Quality (Objective) - Optional

    Time frame: Baseline, 6 months, 12 months, 18 months

    Sleep quality parameters will be measured using ActiGraph

  17. Brain Function - Optional

    Time frame: Baseline, 6 months, 12 months

    Brain function will be measured using functional near-infrared spectroscopy

Study contacts

Contact information is provided by the study sponsor or research team.

Teresa Liu-Ambrose, PhD

CONTACT

[email protected]

6046178047

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Vancouver Coastal Health Research Institute

Registry information

Official study title

ACTIVE: Adding Life to Years in Cognitive Frailty by Preventing Falls

Acronym: ACTIVE

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Mar 3, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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