Frail Older Adults, Frailty, Frailty in Aging, Frailty Syndrome
Conditions
Keywords
Frailty, Rehabilitation, Dance
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).
Interventions
OTHERDance Rehabilitation Intervention
Cognitive 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.
Sponsors
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Walking Speed | Baseline and 3-months | Walking speed will be assessed with the 400-m Walk Test \[walking speed, m/s\]. 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 with the Montreal Cognitive Assessment \[total score\]. Higher scores indicate better cognition \[range 0-30\]. |
| 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 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 | Number of emergency room visits and hospitalizations will be recorded. Higher number of visits 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. |
| 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 \[range 20-80\]. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Individual-level Economic Evaluation | Baseline, 3-months, and 12-months | 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. |
Countries
Canada
Contacts
Primary ContactPatricia Hewston, PhD
Outcome results
None listed