Virtual GERAS DANCE Feasibility RCT

Not Applicable

• Conditions: Aging
• Interventions: Behavioral: Virtual GERAS DANCE

• Registration Number: NCT05202522
• Lead Sponsor: McMaster University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-01-07
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-01-21
• Status Verified: 2022-03
• Study Start: 2022-03-01
• Last Update Submitted: 2022-06-02
• Last Update Posted: 2022-06-03
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual GERAS DANCE Group	Virtual GERAS DANCE	Virtual GERAS DANCE will be delivered for 1-hr twice weekly for 6 weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

McMaster University - St. Peter's Hospital; 🇨🇦 Hamilton, Ontario, Canada