Virtual GERAS DANCE Feasibility RCT

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05202522
• Other study ID #: 14400
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: March 2022
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging

Intervention

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.

Locations

Country	Name	City	State
Canada	McMaster University - St. Peter's Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	5 patient/month	[Time Frame: Through study completion, an average of 10 months]
Primary	Retention Rate	target = 70%	[Time Frame: Through study completion, an average of 10 months]
Primary	Data Collection completion	target = 70%	[Time Frame: Through study completion, an average of 10 months]
Primary	Proportion of recruited patients	target = 70%	[Time Frame: Through study completion, an average of 10 months]
Primary	Refusal Rate	target = 70%	[Time Frame: Baseline, 6-weeks]
Secondary	Change in Mobility	Assessed by the 5x Sit-to-Stand (time to complete). Faster times to complete indicate better performance.	Baseline and 6 Weeks
Secondary	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
Secondary	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
Secondary	Change in Frailty	Assessed by Fit-Frailty App. Higher scores indicate greater degree of frailty [range 0-1].	Baseline and 6 Weeks
Secondary	Change in Cognition	Assessed by Telephone-based Montreal Cognitive Assessment (MoCA). Higher scores indicate better cognition [range 0-30].	Baseline and 6 Weeks
Secondary	Change in Mood	Assessed by Depression Anxiety Stress Scale (DASS-21) Questionnaire. Higher scores indicate greater depression [range 0-120].	Baseline and 6 Weeks