Cognitive Groove (Brought to You by GERAS DANCE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-100
SponsorMcMaster University
About this trial
The goal of this clinical trial is to determine the effect of a community-based rehabilitation intervention (Cognitive Groove, Brought to you by GERAS DANCE), compared to usual care, on clinical outcomes in community-dwelling older adults living with frailty. The main questions it aims to answer are:
1. In community-dwelling older adults living with frailty, is Cognitive Groove more effective than usual care in improving functional movement, physical performance and strength? 2. In community-dwelling older adults living with frailty is Cognitive Groove more effective than usual care in improving frailty status, fear of falling, balance confidence, mood, cognition, grip strength, activities of daily living, life space mobility, loneliness, and quality of life? 3. As a community-based rehabilitation intervention, is Cognitive Groove a cost-effective intervention embedded within the community for older adults living with frailty after 12-months?
Participants will participate in Cognitive Groove classes twice per week for 3 months or receive no intervention (usual care).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Community-dwelling aged ≥65 years
At high risk for mobility disability/functional limitations as assessed by the FRAIL Scale ≥2
Able to ambulate independently (25 m) with or without an assistive device
Able to follow two-step instructions
Disqualifiers
Unable to speak or understand English
Current regular participation in a structured exercise program or receiving active physical therapy services
Severe cardiac or pulmonary disease
Unstable angina or heart failure
Trial design
Design model
Parallel
Treatments tested in this trial
Dance Rehabilitation Intervention
Other interventionCognitive Groove (GERAS DANCE) presents a novel approach to increasing or maintaining independence and quality of life by improving physical performance and mobility using reminiscent music and rhythmic movement in a fun, safe environment. Cognitive Groove was designed to meet the complex needs of older adults with frailty. Our pilot quasi-experimental studies have demonstrated Cognitive Groove results in clinically significant improvements in walking speed by 0.1 m/s with enhanced temporal-spatial walking parameters and improved lower extremity function, including balance and chair stands.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Cognitive Groove (GERAS DANCE)Experimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Physical Performance
Physical function will be assessed with the Short Performance Physical Battery \[total score\]. Higher scores indicate better physical performance \[range 0-12\].
Time frame
Baseline and 3-monthsSecondary outcomes
1
Change in Walking Speed
Walking speed will be assessed with the 400-m Walk Test \[walking speed, m/s\]. Faster walking speeds indicate better performance.
Time frame
Baseline and 3-months2
Change in Walking Speed
Change in walking speed will be assessed by 8-ft walking speed \[m/s\]. Faster walking speeds indicate better performance.
Time frame
Baseline to 3-months3
Change in Functional Mobility
Functional mobility will be assessed with the Timed Up and Go (TUG) Test \[total time, s\]. A higher score indicates a greater falls risk (greater or equal to 12 sec) and lower functional mobility.
Time frame
Baseline and 3-months4
Change in Dual Task Ability
Dual-task ability will be assessed by the TUG-Cognitive (Dual Task Ability) \[total time, s\]. Higher time indicates worse performance.
Time frame
Baseline and 3-monthsOther outcomes
1
Individual-level Economic Evaluation
Individual-level economic evaluations will be assessed by changes in direct medical costs and effectiveness outcomes (e.g., quality-adjusted life years - QALYs), calculate and compare the incremental cost-effectiveness ratio (ICER) (e.g., $/ QALY gained, $/ a visit averted) against a willingness-to-pay threshold ($50,000/QALY) to show if this program represents good value for money.
Time frame
Baseline, 3-months, and 12-monthsSponsors and contacts
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Source ClinicalTrials.gov