NCT06870149

Brief 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. 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. 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. 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?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Jun 2025Dec 2027

First Submitted

Initial submission to the registry

March 5, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 10, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

2.5 years

First QC Date

March 5, 2025

Last Update Submit

June 27, 2025

Conditions

Keywords

FrailtyRehabilitationDance

Outcome Measures

Primary Outcomes (1)

  • Change in Physical Performance

    Physical function will be assessed with the Short Performance Physical Battery \[total score\]. Higher scores indicate better physical performance \[range 0-12\].

    Baseline and 3-months

Secondary Outcomes (24)

  • Change in Walking Speed

    Baseline and 3-months

  • Change in Walking Speed

    Baseline to 3-months

  • Change in Functional Mobility

    Baseline and 3-months

  • Change in Dual Task Ability

    Baseline and 3-months

  • Change in Static Postural Control

    Baseline and 3-months

  • +19 more secondary outcomes

Other Outcomes (1)

  • Individual-level Economic Evaluation

    Baseline, 3-months, and 12-months

Study Arms (2)

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.

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.

Interventions

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.

Also known as: Cognitive Groove (GERAS DANCE)
Cognitive Groove (GERAS DANCE)

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hamilton, Ontario, L8M 1W9, Canada

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alexandra Papaioannou, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Hewston, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Medicine

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 11, 2025

Study Start

June 10, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

July 1, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations