Preventing Falls in Older Adults With Cognitive Frailty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-89
SponsorUniversity of British Columbia
About this trial
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)?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Balance and Strength Training Exercises with Health Coaching
BehavioralThe 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 Session
Other interventionAll active comparator participants will be invited to join monthly interactive social and education sessions via Zoom or in-person (hybrid delivery).
Treatment groups
328 Participants
are divided into 2 treatment groupsGroup A: Educational ControlActive comparator 1 intervention
Group B: Otago Exercise Program (OEP) PlusExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Falls
The number of self-reported falls during the 12-month intervention period (i.e., rate of falls).
Time frame
Daily tracking over 12 monthsSecondary outcomes
1
Short Physical Performance Battery
A physical performance battery out of 12 points (max. performance).
Time frame
Baseline, 6 months, 12 months, 18 months2
Montreal Cognitive Assessment
A test that covers multiple cognitive domains. Often used to screen for mild cognitive impairment.
Time frame
Baseline, 6 months, 12 months, 18 months3
Falls during followup period
The number of self-reported falls during the 6-month ifollowup period (i.e., rate of falls).
Time frame
Daily tracking from 12 months (trial completion) to end of 6-month followup (18 months)4
NIH Cognitive Toolbox
Cognitive function measured using the NIH Cognitive Toolbox
Time frame
Baseline, 6 months, 12 months, 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of British Columbia
Lead sponsor
Vancouver Coastal Health Research Institute
Collaborator
Source ClinicalTrials.gov