Clinical trial NCT06854731: Preventing Falls in Older Adults With Cognitive Frailty
Official title: ACTIVE: Adding Life to Years in Cognitive Frailty by Preventing Falls
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Falls
Frailty
Mild Cognitive Impairment
Keywords: execise
falls
cognitive frailty
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Vancouver Coastal Health Research Institute
First posted: 2025-03-03
Enrollment: 328
Sex: ALL
Minimum age (years): 70
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Falls
timeFrame: Daily tracking over 12 months
Secondary outcomes:
measure: Short Physical Performance Battery
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Montreal Cognitive Assessment
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Falls during followup period
timeFrame: Daily tracking from 12 months (trial completion) to end of 6-month followup (18 months)
measure: NIH Cognitive Toolbox
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Processing speed
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Memory
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Gait Speed
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Muscle Strength
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Community Mobility
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Functional Mobility
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Fatigue
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Quality of Life
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months
measure: Fear of Falling
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Health Resource Utilization (HRU)
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months
measure: Sleep Quality (Subjective)
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Sleep Quality (Objective) - Optional
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Brain Function - Optional
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Centre for Aging SMART at VCH, University of BC
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Teresa Liu-Ambrose, PhD
role: PRINCIPAL_INVESTIGATOR
References: