Preventing Falls in Older Adults With Cognitive Frailty (ACTIVE)

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)?

Study Overview

• Status: Recruiting
• Conditions: Frailty; Mild Cognitive Impairment; Falls
• Intervention / Treatment: Other: Education Session; Behavioral: Balance and Strength Training Exercises with Health Coaching

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 Type: Interventional
• Enrollment (Estimated): 328
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Teresa Liu-Ambrose, PhD; Phone Number: 6046178047; Email: teresa.ambrose@ubc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z1M9
      • Recruiting
      • Centre for Aging SMART at VCH, University of BC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Otago Exercise Program (OEP) Plus; 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	Behavioral: Balance and Strength Training Exercises with Health Coaching; 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+)
Active Comparator: Educational Control; All active control participants will be invited to join monthly interactive education sessions via Zoom or in-person.	Other: Education Session; All active comparator participants will be invited to join monthly interactive social and education sessions via Zoom or in-person (hybrid delivery).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Falls	The number of self-reported falls during the 12-month intervention period (i.e., rate of falls).	Daily tracking over 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Physical Performance Battery	A physical performance battery out of 12 points (max. performance).	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.	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).	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	Baseline, 6 months, 12 months, 18 months
Processing speed	Processing speed measured by Digit Symbol Substitute Test	Baseline, 6 months, 12 months, 18 months
Memory	Memory measured by the Rey Auditory Verbal Learning Test	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)	Baseline, 6 months, 12 months, 18 months
Muscle Strength	Dominant quadriceps strength and dominant hand grip strength.	Baseline, 6 months, 12 months, 18 months
Community Mobility	Life Space Questionnaire to measure community mobility	Baseline, 6 months, 12 months, 18 months
Functional Mobility	Timed Up and Go Test to measure functional mobility	Baseline, 6 months, 12 months, 18 months
Fatigue	The 9-item Fatigue Severity Scale100 will be used to assess how fatigue interferes with certain activities and its severity.	Baseline, 6 months, 12 months, 18 months
Quality of Life	The EuroQol EQ-5 Domain (5D)-5 Level (5L) (EQ-5D-5L) will assess quality of life	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).	Baseline, 6 months, 12 months, 18 months
Health Resource Utilization (HRU)	Cost data will be collected every 3 months using the HRU questionnaire	Baseline, 3 months, 6 months, 9 months, 12 months, 18 months
Sleep Quality (Subjective)	Sleep quality will be measured subjectively using the Pittsburgh Quality Sleep Index	Baseline, 6 months, 12 months, 18 months
Sleep Quality (Objective) - Optional	Sleep quality parameters will be measured using ActiGraph	Baseline, 6 months, 12 months, 18 months
Brain Function - Optional	Brain function will be measured using functional near-infrared spectroscopy	Baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Vancouver Coastal Health Research Institute
• Investigators: Principal Investigator: Teresa Liu-Ambrose, PhD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: February 17, 2025
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): March 3, 2025

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: falls; execise; cognitive frailty
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurocognitive Disorders; Cognition Disorders; Frailty; Cognitive Dysfunction
• Other Study ID Numbers: H23-01584

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No