Cognitive Groove (Brought to You by GERAS DANCE)

Not Applicable

Not yet recruiting

• Conditions: Frailty; Frail Older Adults; Frailty in Aging; Frailty Syndrome

• Registration Number: NCT06870149
• Lead Sponsor: McMaster University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-10
• Last Update Submitted: 2025-03-10
• Study First Posted: 2025-03-11
• Last Update Posted: 2025-03-11
• Study Start: 2025-06
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• 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
• Medical clearance from referring clinician, or for self-referrals, medical clearance from family physician to safely participate in exercise
• Can arrange transportation to the YMCA up to 2 times per week

Exclusion Criteria

• 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
• Severe osteoarthritis (e.g., awaiting joint replacement)
• Parkinson's disease or other progressive neurological disorder
• Receiving palliative care
• Travel/commitments requiring missing more than two weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Physical Performance	Baseline and 3-months	Physical function will be assessed with the Short Performance Physical Battery \[total score\]. Higher scores indicate better physical performance \[range 0-12\].

Secondary Outcome Measures

Name	Time	Method
Change in Walking Speed	Baseline to 3-months	Change in walking speed will be assessed by the 4 Metre Walk Test (4MWT) \[walking speed, m/s\]. Faster walking speeds indicate better performance.
Change in Functional Mobility	Baseline and 3-months	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.
Change in Dual Task Ability	Baseline and 3-months	Dual-task ability will be assessed by the TUG-Cognitive (Dual Task Ability) \[total time, s\]. Higher time indicates worse performance.
Change in Static Postural Control	Baseline and 3-months	Static postural control will be assessed by the Single Leg Stance Test \[total time, s\]. Higher scores indicate better postural control.
Change in Hand Grip Strength	Baseline and 3-months	Hand grip strength will be assessed with a handgrip dynamometer \[kg\]. Higher measures indicate higher grip strength.
Change in Cognition	Baseline and 3-months	Cognition will be assessed using the Digit Symbol Substitution Test (DSST) \[total score\]. Higher scores indicate better cognition \[range 0-100\].
Change in Frailty	Baseline and 3-months	Frailty will be assessed with the Fit-Frailty Index \[total score\]. Higher scores indicate greater frailty \[range 0-1\].
Change in Fear of Falling	Baseline and 3-months	Fear of falling will be assessed by the Falls Efficacy Scale International (FES-I) \[total score\]. Higher scores indicate greater fear of falling \[range 16-64\].
Change in Balance Confidence	Baseline and 3-months	Balance confidence will be assessed by the Activities-specific Balance Confidence (ABC) Scale \[total score\]. Higher scores indicate higher confidence \[range 0-100\].
Change in Depression/Mood	Baseline and 3-months	Depression and mood will be assessed with the Patient Health Questionnaire-9 (PHQ-9) \[total score\]. Higher scores indicate more depressive symptoms \[range 0-27\].
Change in Loneliness	Baseline and 3-months	Loneliness will be assessed by the University of California Los Angeles (UCLA) Loneliness Scale \[total score\]. Higher scores in indicate higher loneliness \[range 20-80\].
Change in Basic Activities of Daily Living	Baseline and 3-months	Activities of daily living will be assessed with the Katz activities of daily living questionnaire \[total score\]. Lower scores indicate greater impairment \[range 0-6\].
Change in Instrumental Activities of Daily Living	Baseline and 3-months	Activities of daily living will be assessed with Lawton instrumental activities of daily living questionnaire \[total scores\]. Lower scores indicate greater impairment \[range 0-8\].
Change in Life Space Mobility	Baseline and 3-months	Life space mobility will be assessed with the Life Space Assessment \[total score\]. Higher scores indicate a larger life space \[range 0-120\].
Change in Health-related Quality of Life	Baseline, 3-months, and 12-months	Health-related quality of life will be assessed using the Health Utilities Index (HUI). Higher scores indicate better health-related quality of life \[range 0-1\].
Change in Healthcare Utilization	Baseline, 3-months, and 12-months	Healthcare services use will be recorded. Higher number of visits, medications, etc., indicates higher healthcare utilization.
Change in Falls	Baseline to 3-months	Number of falls will be assessed by self-report and electronic health record.
Change in Falls-Related Injuries	Baseline to 3-months	Number of falls-related injuries will be assessed by self-report and electronic health record.
Change in Mobility	Baseline to 3-months	Change in mobility will be assessed by the total number of steps taken daily (e.g., Actigraph accelerometer). Higher number of steps indicates greater mobility.
Adherence	Baseline to 3-months	Class attendance and homework completion will be recorded \[total number completed\]. Higher class attendance and homework completion indicates greater adherence.