Clinical trial NCT05202522: Virtual GERAS DANCE Feasibility RCT
Official title: Dancing to Improve Mobility and Cognition: A Feasibility Randomized Control Trial of Virtual GERAS DANCE
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Keywords: Dance
Exercise
Rehabilitation
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 46
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment Rate
timeFrame: [Time Frame: Through study completion, an average of 10 months]
measure: Retention Rate
timeFrame: [Time Frame: Through study completion, an average of 10 months]
measure: Data Collection completion
timeFrame: [Time Frame: Through study completion, an average of 10 months]
measure: Proportion of recruited patients
timeFrame: [Time Frame: Through study completion, an average of 10 months]
measure: Refusal Rate
timeFrame: [Time Frame: Baseline, 6-weeks]
Secondary outcomes:
measure: Change in Mobility
timeFrame: Baseline and 6 Weeks
measure: Change in Balance
timeFrame: Baseline and 6 Weeks
measure: Change in Falls Self-Efficacy
timeFrame: Baseline and 6 Weeks
measure: Change in Frailty
timeFrame: Baseline and 6 Weeks
measure: Change in Cognition
timeFrame: Baseline and 6 Weeks
measure: Change in Mood
timeFrame: Baseline and 6 Weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University - St. Peter's Hospital
state: Ontario
Study officials:
affiliation: Scientific Director, GERAS Centre for Aging Research
name: Alexandra Papaioannou, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: