Centre for Aging SMART at VCH, University of BC
Vancouver, British Columbia, V5Z1M9, Canada
Location status: Recruiting
NCT Number: NCT06854731
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)?
Interested in participating?
Request Info65 year–89 year
All sexes
Interventional
Not applicable
Vancouver, British Columbia, V5Z1M9, Canada
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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+)
All active comparator participants will be invited to join monthly interactive social and education sessions via Zoom or in-person (hybrid delivery).
Time frame: Daily tracking over 12 months
The number of self-reported falls during the 12-month intervention period (i.e., rate of falls).
Time frame: Baseline, 6 months, 12 months, 18 months
A physical performance battery out of 12 points (max. performance).
Time frame: Baseline, 6 months, 12 months, 18 months
A test that covers multiple cognitive domains. Often used to screen for mild cognitive impairment.
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).
Time frame: Baseline, 6 months, 12 months, 18 months
Cognitive function measured using the NIH Cognitive Toolbox
Time frame: Baseline, 6 months, 12 months, 18 months
Processing speed measured by Digit Symbol Substitute Test
Time frame: Baseline, 6 months, 12 months, 18 months
Memory measured by the Rey Auditory Verbal Learning Test
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)
Time frame: Baseline, 6 months, 12 months, 18 months
Dominant quadriceps strength and dominant hand grip strength.
Time frame: Baseline, 6 months, 12 months, 18 months
Life Space Questionnaire to measure community mobility
Time frame: Baseline, 6 months, 12 months, 18 months
Timed Up and Go Test to measure functional mobility
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.
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
Time frame: Baseline, 6 months, 12 months, 18 months
Fear of falling as assessed by the Iconographical Falls Efficacy Scale (Icon-FES).
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
Time frame: Baseline, 6 months, 12 months, 18 months
Sleep quality will be measured subjectively using the Pittsburgh Quality Sleep Index
Time frame: Baseline, 6 months, 12 months, 18 months
Sleep quality parameters will be measured using ActiGraph
Time frame: Baseline, 6 months, 12 months
Brain function will be measured using functional near-infrared spectroscopy
Contact information is provided by the study sponsor or research team.
University of British Columbia
Other
ACTIVE: Adding Life to Years in Cognitive Frailty by Preventing Falls
Acronym: ACTIVE
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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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