Virtual GERAS DANCE Feasibility RCT

August 20, 2025 updated by: McMaster University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: [Time Frame: Through study completion, an average of 10 months]
5 patient/month
[Time Frame: Through study completion, an average of 10 months]
Retention Rate
Time Frame: [Time Frame: Through study completion, an average of 10 months]
target ≥ 70%
[Time Frame: Through study completion, an average of 10 months]
Data Collection completion
Time Frame: [Time Frame: Through study completion, an average of 10 months]
target ≥ 70%
[Time Frame: Through study completion, an average of 10 months]
Proportion of recruited patients
Time Frame: [Time Frame: Through study completion, an average of 10 months]
target ≥ 70%
[Time Frame: Through study completion, an average of 10 months]
Refusal Rate
Time Frame: [Time Frame: Baseline, 6-weeks]
target ≥ 70%
[Time Frame: Baseline, 6-weeks]

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Mobility
Time Frame: Baseline and 6 Weeks
Assessed by the 5x Sit-to-Stand (time to complete). Faster times to complete indicate better performance.
Baseline and 6 Weeks
Change in Balance
Time Frame: 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].
Baseline and 6 Weeks
Change in Falls Self-Efficacy
Time Frame: 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].
Baseline and 6 Weeks
Change in Frailty
Time Frame: Baseline and 6 Weeks
Assessed by Fit-Frailty App. Higher scores indicate greater degree of frailty [range 0-1].
Baseline and 6 Weeks
Change in Cognition
Time Frame: Baseline and 6 Weeks
Assessed by Telephone-based Montreal Cognitive Assessment (MoCA). Higher scores indicate better cognition [range 0-30].
Baseline and 6 Weeks
Change in Mood
Time Frame: Baseline and 6 Weeks
Assessed by Depression Anxiety Stress Scale (DASS-21) Questionnaire. Higher scores indicate greater depression [range 0-120].
Baseline and 6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alexandra Papaioannou, MD, MSc, Scientific Director, GERAS Centre for Aging Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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