Virtual GERAS DANCE Feasibility RCT

Study Overview
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Brief Summary
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GERAS DANcing for Cognition and Exercise (DANCE) is a therapeutic mind-body program for older adults (aged 60+) developed with rehabilitation and geriatric medicine expertise at the GERAS Centre for Aging Research at Hamilton Health Sciences and McMaster University. This study will examine if a virtual dance program is feasible for older adults and if dancing at home can benefit mind-body health, self-confidence, and mood.

Detailed Description
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GERAS DANCE fulfills an urgent need in our community to provide tailored evidence-based programming to help improve the health of older adults and was adapted for virtual implementation. This randomized controlled trial (RCT) aims to measure (1) the feasibility of virtual GERAS DANCE in older adults to inform a large full-scale study, and (2) the potential effects of virtual GERAS DANCE on mobility, balance self-efficacy, cognition, frailty, and mood in older adults. This study will utilize a single-center, prospective, parallel-group randomized controlled feasibility approach. This RCT will involve 48 older adults using a person-centered and coordinated model of care embedded into existing community health partnerships. Participants will be randomized to receive 6-weeks of virtual GERAS DANCE or usual care. All participants randomized to usual care will receive the dance intervention after study completion for equal opportunity to participate in the virtual GERAS DANCE program. The progressive GERAS DANCE curricula will be delivered virtually for 1-hr class twice weekly by a certified GERAS DANCE instructor. GERAS DANCE curricula include gradual increases in cognitive load and are based on motor learning principles of the ABCs of movement Agility, Balance, and Coordination. The ABCs of movement is essential to quickly and efficiently change the body position with balance and coordination. Assessments of mobility, balance self-efficacy, cognition, frailty, and mood will occur at baseline and 6-weeks.

Official Title
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Dancing to Improve Mobility and Cognition: A Feasibility Randomized Control Trial of Virtual GERAS DANCE

Conditions
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Aging

Intervention / Treatment
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* Behavioral: Virtual GERAS DANCE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Community-dwelling adults aged ≥ 60 years of age; Has access, or has a caregiver who has access to a device at home that can support a videoconferencing service Able to ambulate independently with or without a walking aid; OR with caregiver supervision at home; Family physician's signature on a medical clearance form to ensure they are cleared to exercise safely. Exclusion Criteria: Unable to speak or understand English and has no caregiver for translation; Significant cognitive impairment where they may have difficulty following two-step commands; Unstable angina or unstable heart failure; Travel plans that would result in missing greater than 20% of the trial's 6-week duration; Currently attending a group exercise program.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>During the study. participants in the control group will not receive the virtual GERAS DANCE intervention. However, they will receive the virtual GERAS DANCE intervention following study completion for equal opportunity to participate in the program. | |
| Experimental: Virtual GERAS DANCE Group<br>Virtual GERAS DANCE will be delivered for 1-hr twice weekly for 6 weeks. | Behavioral: Virtual GERAS DANCE<br>* Dance is a form of aerobic exercise that involves multicomponent training with physical, cognitive, and social dimensions and may have synergetic benefits when delivered in combination. GERAS DANcing for Cognition and Exercise (DANCE), a community-based rehabilitation program for older adults with cognitive decline and/or mobility impairments, has been adapted for virtual delivery through videoconferencing systems. Participants will receive twice-weekly (one hour per session) virtual dance sessions for a total of 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Rate | 5 patient/month | [Time Frame: Through study completion, an average of 10 months] | 
| Retention Rate | target ≥ 70% | [Time Frame: Through study completion, an average of 10 months] | 
| Data Collection completion | target ≥ 70% | [Time Frame: Through study completion, an average of 10 months] | 
| Proportion of recruited patients | target ≥ 70% | [Time Frame: Through study completion, an average of 10 months] | 
| Refusal Rate | target ≥ 70% | [Time Frame: Baseline, 6-weeks] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mobility | Assessed by the 5x Sit-to-Stand (time to complete). Faster times to complete indicate better performance. | Baseline and 6 Weeks | 
| Change in Balance | Balance confidence will be assessed using the Activities-specific Balance Confidence Scale (ABCs). Higher scores indicate greater balance confidence [range 0-100]. | Baseline and 6 Weeks | 
| Change in Falls Self-Efficacy | Level of concern for falling will be assessed using the Falls Efficacy Scale - International (FES-I). Higher scores indicate greater concern for falling [range 1-4]. | Baseline and 6 Weeks | 
| Change in Frailty | Assessed by Fit-Frailty App. Higher scores indicate greater degree of frailty [range 0-1]. | Baseline and 6 Weeks | 
| Change in Cognition | Assessed by Telephone-based Montreal Cognitive Assessment (MoCA). Higher scores indicate better cognition [range 0-30]. | Baseline and 6 Weeks | 
| Change in Mood | Assessed by Depression Anxiety Stress Scale (DASS-21) Questionnaire. Higher scores indicate greater depression [range 0-120]. | Baseline and 6 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dance, Exercise, Rehabilitation