FrailtyGERAS DANCENCT06870149
Cognitive Groove (Brought to You by GERAS DANCE)
A study testing Dance Rehabilitation Intervention in people with Frailty and Frail Older Adults, run by McMaster University at 1 site in Canada.
Trial summary
The goal of this clinical trial is to determine the effect of a community-based rehabilitation intervention (Cognitive Groove, Brought to you by GERAS DANCE), compared to usual care, on clinical outcomes in community-dwelling older adults living with frailty. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Frailty, Frail Older Adults, Frailty in Aging
- What is being tested?
- Dance Rehabilitation Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jun 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Community-dwelling aged ≥65 years
- At high risk for mobility disability/functional limitations as assessed by the FRAIL Scale ≥2
- Able to ambulate independently (25 m) with or without an assistive device
- Able to follow two-step instructions
- Medical clearance from referring clinician, or for self-referrals, medical clearance from family physician to safely participate in exercise
- Can arrange transportation to the YMCA up to 2 times per week
Who cannot join
- Unable to speak or understand English
- Current regular participation in a structured exercise program or receiving active physical therapy services
- Severe cardiac or pulmonary disease
- Unstable angina or heart failure
- Severe osteoarthritis (e.g., awaiting joint replacement)
- Parkinson's disease or other progressive neurological disorder
- Receiving palliative care
- Travel/commitments requiring missing more than two weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Geras Centre for Aging Research, St. Peter's Hospital, Hamilton Health Sciences
Hamilton, Ontario, L8M 1W9
Patricia Hewston, PhD, 905-521-2100 ext. 74161, hewstonp@hhsc.ca
Alexandra Papaioannou, MD
About this study
Official title: Does Cognitive Groove (Brought to You by GERAS DANCE) Improve Physical Performance in Community-Dwelling Older Adults With Frailty: A Parallel Randomized Controlled Trial
The goal of this clinical trial is to determine the effect of a community-based rehabilitation intervention (Cognitive Groove, Brought to you by GERAS DANCE), compared to usual care, on clinical outcomes in community-dwelling older adults living with frailty. The main questions it aims to answer are:
- In community-dwelling older adults living with frailty, is Cognitive Groove more effective than usual care in improving functional movement, physical performance and strength?
- In community-dwelling older adults living with frailty is Cognitive Groove more effective than usual care in improving frailty status, fear of falling, balance confidence, mood, cognition, grip strength, activities of daily living, life space mobility, loneliness, and quality of life?
- As a community-based rehabilitation intervention, is Cognitive Groove a cost-effective intervention embedded within the community for older adults living with frailty after 12-months?
Participants will participate in Cognitive Groove classes twice per week for 3 months or receive no intervention (usual care).
- Conditions
- Frailty, Frail Older Adults, Frailty in Aging, Frailty Syndrome
- Being tested
- Dance Rehabilitation Intervention
- Keywords
- Frailty, Rehabilitation, Dance
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance Rehabilitation InterventionOther
Also called Cognitive Groove (GERAS DANCE)
Cognitive Groove (GERAS DANCE) presents a novel approach to increasing or maintaining independence and quality of life by improving physical performance and mobility using reminiscent music and rhythmic movement in a fun, safe environment. Cognitive Groove was designed to meet the complex needs of older adults with frailty. Our pilot quasi-experimental studies have demonstrated Cognitive Groove results in clinically significant improvements in walking speed by 0.1 m/s with enhanced temporal-spatial walking parameters and improved lower extremity function, including balance and chair stands.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Groove (GERAS DANCE) | Experimental | Classes will occur twice per week for 3 months. Classes follow a consistent sequence of activities (orientation and socialization [10-mins]; warm-up [5-mins]; structured dance [30-mins]; cool-down [5-mins]; socialization and review of weekly hand-outs for balance exercises [10-mins]. The curriculum schedule includes five foundations and seven routines. Cognitive Groove (GERAS DANCE) foundations emphasize learning the ABCs of movement and increasing participants' confidence to move their bodies forward and backward and side-to-side with improved speed and rhythmicity. Cognitive Groove (GERAS DANCE) routines combine the foundational skills into full choreographed dances to music from the '50s and '60s (e.g., rock and roll, jazz, salsa, cha cha cha, rhythm soul, swing, disco, and Bollywood). Participants will receive an intervention-specific study manual that describes the homework exercises for each week. Receives: Other: Dance Rehabilitation Intervention |
| Usual Care | No intervention | The control arm participants will continue with their usual care and normal activities. They will not receive any intervention during the study but will be given the opportunity to participate in Cognitive Groove (GERAS DANCE) programming after the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Performance
Physical function will be assessed with the Short Performance Physical Battery [total score]. Higher scores indicate better physical performance [range 0-12].
Measured: Baseline and 3-months
Secondary outcomes (24)
Change in Walking Speed
Walking speed will be assessed with the 400-m Walk Test [walking speed, m/s]. Faster walking speeds indicate better performance.
Measured: Baseline and 3-months
Change in Walking Speed
Change in walking speed will be assessed by 8-ft walking speed [m/s]. Faster walking speeds indicate better performance.
Measured: Baseline to 3-months
Change in Functional Mobility
Functional mobility will be assessed with the Timed Up and Go (TUG) Test [total time, s]. A higher score indicates a greater falls risk (greater or equal to 12 sec) and lower functional mobility.
Measured: Baseline and 3-months
Change in Dual Task Ability
Dual-task ability will be assessed by the TUG-Cognitive (Dual Task Ability) [total time, s]. Higher time indicates worse performance.
Measured: Baseline and 3-months
Change in Static Postural Control
Static postural control will be assessed by the Single Leg Stance Test [total time, s]. Higher scores indicate better postural control.
Measured: Baseline and 3-months
Change in Hand Grip Strength
Hand grip strength will be assessed with a handgrip dynamometer [kg]. Higher measures indicate higher grip strength.
Measured: Baseline and 3-months
Change in Cognition
Cognition will be assessed with the Montreal Cognitive Assessment [total score]. Higher scores indicate better cognition [range 0-30].
Measured: Baseline and 3-months
Change in Cognition
Change in cognition will be assessed using the Trail Making Test (TMT) [total time, s]. Higher time indicates worse performance.
Measured: Baseline and 3-months
Change in Cognition
Cognition will be assessed using the Digit Symbol Substitution Test (DSST) [total score]. Higher scores indicate better cognition [range 0-100].
Measured: Baseline and 3-months
Change in Frailty
Frailty will be assessed with the Fit-Frailty Index [total score]. Higher scores indicate greater frailty [range 0-1].
Measured: Baseline and 3-months
Change in Fear of Falling
Fear of falling will be assessed by the Falls Efficacy Scale International (FES-I) [total score]. Higher scores indicate greater fear of falling [range 16-64].
Measured: Baseline and 3-months
Change in Balance Confidence
Balance confidence will be assessed by the Activities-specific Balance Confidence (ABC) Scale [total score]. Higher scores indicate higher confidence [range 0-100].
Measured: Baseline and 3-months
Change in Depression/Mood
Depression and mood will be assessed with the Patient Health Questionnaire-9 (PHQ-9) [total score]. Higher scores indicate more depressive symptoms [range 0-27].
Measured: Baseline and 3-months
Change in Loneliness
Loneliness will be assessed by the University of California Los Angeles (UCLA) Loneliness Scale [total score]. Higher scores in indicate higher loneliness [range 20-80].
Measured: Baseline and 3-months
Change in Basic Activities of Daily Living
Activities of daily living will be assessed with the Katz activities of daily living questionnaire [total score]. Lower scores indicate greater impairment [range 0-6].
Measured: Baseline and 3-months
Change in Instrumental Activities of Daily Living
Activities of daily living will be assessed with Lawton instrumental activities of daily living questionnaire [total scores]. Lower scores indicate greater impairment [range 0-8].
Measured: Baseline and 3-months
Change in Life Space Mobility
Life space mobility will be assessed with the Life Space Assessment [total score]. Higher scores indicate a larger life space [range 0-120].
Measured: Baseline and 3-months
Change in Health-related Quality of Life
Health-related quality of life will be assessed using the Health Utilities Index (HUI). Higher scores indicate better health-related quality of life [range 0-1].
Measured: Baseline, 3-months, and 12-months
Change in Healthcare Utilization
Number of emergency room visits and hospitalizations will be recorded. Higher number of visits indicates higher healthcare utilization.
Measured: Baseline, 3-months, and 12-months
Change in Healthcare Utilization
Healthcare services use will be recorded. Higher number of visits, medications, etc., indicates higher healthcare utilization.
Measured: Baseline, 3-months, and 12-months
Change in Falls
Number of falls will be assessed by self-report and electronic health record.
Measured: Baseline to 3-months
Change in Falls-Related Injuries
Number of falls-related injuries will be assessed by self-report and electronic health record.
Measured: Baseline to 3-months
Change in Mobility
Change in mobility will be assessed by the total number of steps taken daily (e.g., Actigraph accelerometer). Higher number of steps indicates greater mobility.
Measured: Baseline to 3-months
Adherence
Class attendance and homework completion will be recorded [total number completed]. Higher class attendance and homework completion indicates greater adherence.
Measured: Baseline to 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start10 Jun 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Papaioannou, McMaster University
- Investigators
- Alexandra Papaioannou, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870149
- Sponsor's protocol ID
- 18231
- Acronym
- GERAS DANCE
- Status last verified
- Jun 2025
- First submitted
- 5 Mar 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Papaioannou A, Ioannidis G, Kennedy C, Hladysh G, Lee J, Adachi JD, Cowan D, Duarte D, Hategan A, Innes A, Keen S, Marr S, McArthur C, McKenna B, Tarride JE, Thabane L, Rabinovich A, Thrall S, Wang M, Azizudin AM, Choo WLO, Marr C, Perrotta A, Hewston P. Cognitive Groove community-based rehabilitation for older adults: study protocol for a multisite parallel randomized controlled trial. Trials. 2026 May 20;27(1):491. doi: 10.1186/s13063-026-09782-5.
PubMed 42163402
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Cognitive Groove (Brought to You by GERAS DANCE) Improve Physical Performance in Community-Dwelling Older Adults With Frailty: A Parallel Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06870149
- Acronym / sponsor ID
- GERAS DANCE / 18231
- Conditions
- Frailty, Frail Older Adults, Frailty in Aging, Frailty Syndrome
- Keywords
- Frailty, Rehabilitation, Dance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine the effect of a community-based rehabilitation intervention (Cognitive Groove, Brought to you by GERAS DANCE), compared to usual care, on clinical outcomes in community-dwelling older adults living with frailty. The main questions it aims to answer are:
- In community-dwelling older adults living with frailty, is Cognitive Groove more effective than usual care in improving functional movement, physical performance and strength?
- In community-dwelling older adults living with frailty is Cognitive Groove more effective than usual care in improving frailty status, fear of falling, balance confidence, mood, cognition, grip strength, activities of daily living, life space mobility, loneliness, and quality of life?
- As a community-based rehabilitation intervention, is Cognitive Groove a cost-effective intervention embedded within the community for older adults living with frailty after 12-months?
Participants will participate in Cognitive Groove classes twice per week for 3 months or receive no intervention (usual care).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Groove (GERAS DANCE) | Experimental | Other: Dance Rehabilitation InterventionClasses will occur twice per week for 3 months. Classes follow a consistent sequence of activities (orientation and socialization [10-mins]; warm-up [5-mins]; structured dance [30-mins]; cool-down [5-mins]; socialization and review of weekly hand-outs for balance exercises [10-mins]. The curriculum schedule includes five foundations and seven routines. Cognitive Groove (GERAS DANCE) foundations emphasize learning the ABCs of movement and increasing participants' confidence to move their bodies forward and backward and side-to-side with improved speed and rhythmicity. Cognitive Groove (GERAS DANCE) routines combine the foundational skills into full choreographed dances to music from the '50s and '60s (e.g., rock and roll, jazz, salsa, cha cha cha, rhythm soul, swing, disco, and Bollywood). Participants will receive an intervention-specific study manual that describes the homework exercises for each week. |
| Usual Care | No intervention | –The control arm participants will continue with their usual care and normal activities. They will not receive any intervention during the study but will be given the opportunity to participate in Cognitive Groove (GERAS DANCE) programming after the study. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Community-dwelling aged ≥65 years
- At high risk for mobility disability/functional limitations as assessed by the FRAIL Scale ≥2
- Able to ambulate independently (25 m) with or without an assistive device
- Able to follow two-step instructions
- Medical clearance from referring clinician, or for self-referrals, medical clearance from family physician to safely participate in exercise
Key exclusion criteria (8 listed)
- Unable to speak or understand English
- Current regular participation in a structured exercise program or receiving active physical therapy services
- Severe cardiac or pulmonary disease
- Unstable angina or heart failure
- Severe osteoarthritis (e.g., awaiting joint replacement)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dance Rehabilitation InterventionAlso: Cognitive Groove (GERAS DANCE)Cognitive Groove (GERAS DANCE) presents a novel approach to increasing or maintaining independence and quality of life by improving physical performance and mobility using reminiscent music and rhythmic movement in a fun, safe environment. Cognitive Groove was designed to meet the complex needs of older adults with frailty. Our pilot quasi-experimental studies have demonstrated Cognitive Groove results in clinically significant improvements in walking speed by 0.1 m/s with enhanced temporal-spatial walking parameters and improved lower extremity function, including balance and chair stands. | Other | Cognitive Groove (GERAS DANCE) |
Primary outcome
Change in Physical Performance
Time frame: Baseline and 3-months
Physical function will be assessed with the Short Performance Physical Battery [total score]. Higher scores indicate better physical performance [range 0-12].
24 secondary outcomes
Change in Walking Speed
Time frame: Baseline and 3-months
Change in Walking Speed
Time frame: Baseline to 3-months
Change in Functional Mobility
Time frame: Baseline and 3-months
Change in Dual Task Ability
Time frame: Baseline and 3-months
Change in Static Postural Control
Time frame: Baseline and 3-months
Change in Hand Grip Strength
Time frame: Baseline and 3-months
Change in Cognition
Time frame: Baseline and 3-months
Change in Cognition
Time frame: Baseline and 3-months
Change in Cognition
Time frame: Baseline and 3-months
Change in Frailty
Time frame: Baseline and 3-months
Change in Fear of Falling
Time frame: Baseline and 3-months
Change in Balance Confidence
Time frame: Baseline and 3-months
Change in Depression/Mood
Time frame: Baseline and 3-months
Change in Loneliness
Time frame: Baseline and 3-months
Change in Basic Activities of Daily Living
Time frame: Baseline and 3-months
Change in Instrumental Activities of Daily Living
Time frame: Baseline and 3-months
Change in Life Space Mobility
Time frame: Baseline and 3-months
Change in Health-related Quality of Life
Time frame: Baseline, 3-months, and 12-months
Change in Healthcare Utilization
Time frame: Baseline, 3-months, and 12-months
Change in Healthcare Utilization
Time frame: Baseline, 3-months, and 12-months
Change in Falls
Time frame: Baseline to 3-months
Change in Falls-Related Injuries
Time frame: Baseline to 3-months
Change in Mobility
Time frame: Baseline to 3-months
Adherence
Time frame: Baseline to 3-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Derived from this study: PubMed 42163402Papaioannou A, Ioannidis G, Kennedy C, Hladysh G, Lee J, Adachi JD, Cowan D, Duarte D, Hategan A, Innes A, Keen S, Marr S, McArthur C, McKenna B, Tarride JE, Thabane L, Rabinovich A, Thrall S, Wang M, Azizudin AM, Choo WLO, Marr C, Perrotta A, Hewston P. Cognitive Groove community-based rehabilitation for older adults: study protocol for a multisite parallel randomized controlled trial. Trials. 2026 May 20;27(1):491. doi: 10.1186/s13063-026-09782-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandra Papaioannou, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance Rehabilitation Intervention in people with Frailty and Frail Older Adults, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia Hewston, PhD (905-521-2100 ext. 74161, hewstonp@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Performance (time frame: Baseline and 3-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06870149, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.