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NCT Number: NCT06870149

Cognitive Groove (Brought to You by GERAS DANCE)

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. In community-dwelling older adults living with frailty, is Cognitive Groove more effective than usual care in improving functional movement, physical performance and strength? 2. 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? 3. 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).

Recruiting

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Key information

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geras Centre for Aging Research, St. Peter's Hospital, Hamilton Health Sciences

Hamilton, Ontario, L8M 1W9, Canada

Location status: Recruiting

Location contact

Alexandra Papaioannou, MD

PRINCIPAL_INVESTIGATOR

Patricia Hewston, PhD

CONTACT

[email protected]

905-521-2100 ext. 74161

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Dance Rehabilitation Intervention

Other

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 names: Cognitive Groove (GERAS DANCE)

Primary outcomes

  1. 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].

Secondary outcomes

  1. Change in Walking Speed

    Time frame: Baseline and 3-months

    Walking speed will be assessed with the 400-m Walk Test [walking speed, m/s]. Faster walking speeds indicate better performance.

  2. Change in Walking Speed

    Time frame: Baseline to 3-months

    Change in walking speed will be assessed by 8-ft walking speed [m/s]. Faster walking speeds indicate better performance.

  3. Change in Functional Mobility

    Time frame: Baseline and 3-months

    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.

  4. Change in Dual Task Ability

    Time frame: Baseline and 3-months

    Dual-task ability will be assessed by the TUG-Cognitive (Dual Task Ability) [total time, s]. Higher time indicates worse performance.

  5. Change in Static Postural Control

    Time frame: Baseline and 3-months

    Static postural control will be assessed by the Single Leg Stance Test [total time, s]. Higher scores indicate better postural control.

  6. Change in Hand Grip Strength

    Time frame: Baseline and 3-months

    Hand grip strength will be assessed with a handgrip dynamometer [kg]. Higher measures indicate higher grip strength.

  7. Change in Cognition

    Time frame: Baseline and 3-months

    Cognition will be assessed with the Montreal Cognitive Assessment [total score]. Higher scores indicate better cognition [range 0-30].

  8. Change in Cognition

    Time frame: Baseline and 3-months

    Change in cognition will be assessed using the Trail Making Test (TMT) [total time, s]. Higher time indicates worse performance.

  9. Change in Cognition

    Time frame: Baseline and 3-months

    Cognition will be assessed using the Digit Symbol Substitution Test (DSST) [total score]. Higher scores indicate better cognition [range 0-100].

  10. Change in Frailty

    Time frame: Baseline and 3-months

    Frailty will be assessed with the Fit-Frailty Index [total score]. Higher scores indicate greater frailty [range 0-1].

  11. Change in Fear of Falling

    Time frame: Baseline and 3-months

    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].

  12. Change in Balance Confidence

    Time frame: Baseline and 3-months

    Balance confidence will be assessed by the Activities-specific Balance Confidence (ABC) Scale [total score]. Higher scores indicate higher confidence [range 0-100].

  13. Change in Depression/Mood

    Time frame: Baseline and 3-months

    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].

  14. Change in Loneliness

    Time frame: Baseline and 3-months

    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].

  15. Change in Basic Activities of Daily Living

    Time frame: Baseline and 3-months

    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].

  16. Change in Instrumental Activities of Daily Living

    Time frame: Baseline and 3-months

    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].

  17. Change in Life Space Mobility

    Time frame: Baseline and 3-months

    Life space mobility will be assessed with the Life Space Assessment [total score]. Higher scores indicate a larger life space [range 0-120].

  18. Change in Health-related Quality of Life

    Time frame: Baseline, 3-months, and 12-months

    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].

  19. Change in Healthcare Utilization

    Time frame: Baseline, 3-months, and 12-months

    Number of emergency room visits and hospitalizations will be recorded. Higher number of visits indicates higher healthcare utilization.

  20. Change in Healthcare Utilization

    Time frame: Baseline, 3-months, and 12-months

    Healthcare services use will be recorded. Higher number of visits, medications, etc., indicates higher healthcare utilization.

  21. Change in Falls

    Time frame: Baseline to 3-months

    Number of falls will be assessed by self-report and electronic health record.

  22. Change in Falls-Related Injuries

    Time frame: Baseline to 3-months

    Number of falls-related injuries will be assessed by self-report and electronic health record.

  23. Change in Mobility

    Time frame: Baseline to 3-months

    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.

  24. Adherence

    Time frame: Baseline to 3-months

    Class attendance and homework completion will be recorded [total number completed]. Higher class attendance and homework completion indicates greater adherence.

Other outcomes

  1. Individual-level Economic Evaluation

    Time frame: Baseline, 3-months, and 12-months

    Individual-level economic evaluations will be assessed by changes in direct medical costs and effectiveness outcomes (e.g., quality-adjusted life years - QALYs), calculate and compare the incremental cost-effectiveness ratio (ICER) (e.g., $/ QALY gained, $/ a visit averted) against a willingness-to-pay threshold ($50,000/QALY) to show if this program represents good value for money.

Study contacts

Contact information is provided by the study sponsor or research team.

Patricia Hewston, PhD

CONTACT

[email protected]

905-521-2100 ext. 74161

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study 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

Acronym: GERAS DANCE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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