Clinical trial NCT06870149: Cognitive Groove (Brought to You by GERAS DANCE)
Official title: Does Cognitive Groove (Brought to You by GERAS DANCE) Improve Physical Performance in Community-Dwelling Older Adults With Frailty: A Parallel Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Frailty
Frail Older Adults
Frailty in Aging
Frailty Syndrome
Keywords: Frailty
Rehabilitation
Dance
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 250
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in Physical Performance
timeFrame: Baseline and 3-months
Secondary outcomes:
measure: Change in Walking Speed
timeFrame: Baseline and 3-months
measure: Change in Walking Speed
timeFrame: Baseline to 3-months
measure: Change in Functional Mobility
timeFrame: Baseline and 3-months
measure: Change in Dual Task Ability
timeFrame: Baseline and 3-months
measure: Change in Static Postural Control
timeFrame: Baseline and 3-months
measure: Change in Hand Grip Strength
timeFrame: Baseline and 3-months
measure: Change in Cognition
timeFrame: Baseline and 3-months
measure: Change in Cognition
timeFrame: Baseline and 3-months
measure: Change in Cognition
timeFrame: Baseline and 3-months
measure: Change in Frailty
timeFrame: Baseline and 3-months
measure: Change in Fear of Falling
timeFrame: Baseline and 3-months
measure: Change in Balance Confidence
timeFrame: Baseline and 3-months
measure: Change in Depression/Mood
timeFrame: Baseline and 3-months
measure: Change in Loneliness
timeFrame: Baseline and 3-months
measure: Change in Basic Activities of Daily Living
timeFrame: Baseline and 3-months
measure: Change in Instrumental Activities of Daily Living
timeFrame: Baseline and 3-months
measure: Change in Life Space Mobility
timeFrame: Baseline and 3-months
measure: Change in Health-related Quality of Life
timeFrame: Baseline, 3-months, and 12-months
measure: Change in Healthcare Utilization
timeFrame: Baseline, 3-months, and 12-months
measure: Change in Healthcare Utilization
timeFrame: Baseline, 3-months, and 12-months
measure: Change in Falls
timeFrame: Baseline to 3-months
measure: Change in Falls-Related Injuries
timeFrame: Baseline to 3-months
measure: Change in Mobility
timeFrame: Baseline to 3-months
measure: Adherence
timeFrame: Baseline to 3-months
Other outcomes:
measure: Individual-level Economic Evaluation
timeFrame: Baseline, 3-months, and 12-months
Locations:
Study officials:
affiliation: McMaster University
name: Alexandra Papaioannou, MD
role: PRINCIPAL_INVESTIGATOR
References: