Preventing Falls in Older Adults With Cognitive Frailty

NCT06854731 | Recruiting DMC

• 1 other identifier: H23-01584
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

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)?

Conditions

Falls; Frailty; Mild Cognitive Impairment

Keywords

execise; falls; cognitive frailty

Outcome Measures

Primary Outcomes (1)

• Falls

  The number of self-reported falls during the 12-month intervention period (i.e., rate of falls).

  Daily tracking over 12 months

Secondary Outcomes (17)

• Short Physical Performance Battery

  Baseline, 6 months, 12 months, 18 months

• Montreal Cognitive Assessment

  Baseline, 6 months, 12 months, 18 months

• Falls during followup period

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

• NIH Cognitive Toolbox

  Baseline, 6 months, 12 months, 18 months

• Processing speed

  Baseline, 6 months, 12 months, 18 months

Study Arms (2)

Educational Control

ACTIVE COMPARATOR

All active control participants will be invited to join monthly interactive education sessions via Zoom or in-person.

Other: Education Session

Otago Exercise Program (OEP) Plus

EXPERIMENTAL

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

Interventions

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.

Also known as: Otago Exercise Program Plus (OEP+)

Otago Exercise Program (OEP) Plus

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).

Educational Control

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Vancouver Coastal Health Research Institute: collaborator

Study Sites (1)

Centre for Aging SMART at VCH, University of BC

Vancouver, British Columbia, V5Z1M9, Canada

RECRUITING

MeSH Terms

Conditions

Frailty; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Teresa Liu-Ambrose, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa Liu-Ambrose, PhD

CONTACT

6046178047; teresa.ambrose@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: March 3, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

CA (1)