Virtual GERAS DANCE Feasibility RCT

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aging
• Intervention / Treatment: Behavioral: Virtual GERAS DANCE

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8M1W9
      • McMaster University - St. Peter's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; 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; Virtual GERAS DANCE will be delivered for 1-hr twice weekly for 6 weeks.	Behavioral: Virtual GERAS DANCE; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Alexandra Papaioannou, MD, MSc, Scientific Director, GERAS Centre for Aging Research

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Exercise; Dance
• Other Study ID Numbers: 14400

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No