- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02730013
Mind-motor Exercise to Improve Cognition and Functional Fitness (MIND-FUN)
The MIND-FUN Research Study: Mind-motor Exercise to Improve Cognition and Functional Fitness
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Square Stepping Exercise (SSE) can be best described as a visuospatial working memory task, with a stepping response and thus may be considered as a cognitive-physical exercise or alternatively as a type of mind-motor exercise. The SSE program was developed specifically to improve balance and lower extremity functioning and thereby prevent disability and institutionalization in older adults with recent evidence also suggesting that it may positively impact cognitive functioning.
Through the investigators' collaboration with Dr. Mike Sharratt, President of the Schlegel-University of Waterloo Research Institute for Aging, Jaimie Killingbeck, Program for Active Living Coordinator for Schlegel Villages, and Susan Brown, Research Coordinator for the Schlegel-University of Waterloo Research Institute for Aging this study aims to: further assess the feasibility of square-stepping exercise amongst older adults with a variety of cognitive abilities, increase our collaborative efforts in the broader community and to engage older adults in physical activity to improve global cognitive functioning through a mind-motor exercise intervention.
This study will be a cluster randomized controlled trial, stratified by long-term care or full continuum care of the 4 Schlegel Villages involved, not blinded. The investigators will stratify so that 1 long-term care and 1 full continuum will be randomized to begin the square-stepping program immediately, and 1 long-term care and 1 full continuum care will be randomized to usual-care wait list control group, that will begin the program once 12-week measurements are complete. The facilities were stratified to help balance baseline cognition between the intervention and control groups. The 4 facilities are: Long-term Care - Glendale Crossings and St. Claire; Full continuum Care - Tansley Woods and Winston Park. The sites were pre-randomized to allow facilities time to prepare their programming schedules to include square-stepping exercise to their residents. Intervention sites include Glendale Crossings and Tansley Woods and wait-list control sites include St. Claire and Winston Park. Outcomes assessments will be completed by graduate students and research assistants on this project. The assessments will be completed at each of the Villages. The Schlegel Villages staff Kinesiologists/ Exercise Therapists will implement the square-stepping exercise program during the 12 week period. Study staff will train the Schlegel Villages staff on how to implement the program.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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London, Ontario, Canada, N6G 2M1
- Western Centre for Public Health and Family Medicine, Western University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All residents of the 4 Schlegel Villages: Glendale Crossing, St. Clair, Tansley Woods, Winston Park
- Both males and females
Exclusion Criteria:
- Wheelchair bound residents
- Residents who are blind or deaf without aids
- Any residents who may not be able to participate due to health or behaviours in collaboration and discretion of the Schlegel Villages staff.
- Residents who have a diagnosis of dementia, have a score of greater than 3 on the Cognitive Performance Scale (determined by each Schlegel Village) and advice from Schlegel Villages staff will be excluded from specific assessments (dual-task gait; oculomotor function; global cognitive functioning outcomes; Montreal Cognitive Assessment; 2 cognitive questions).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Square Stepping Exercise
Square-Stepping Exercise (SSE) Intervention Participants in this group will attend a square-stepping exercise intervention 60 minutes: 5 minute for attendance, 5-10 minute warm-up 40-45 minute SSE and 5-10 minute cool-down, on two days a week for a duration of 12 weeks.
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Square Stepping Exercise involves mimicking a stepping pattern demonstrated by an instructor. The stepping patterns become progressively difficult and involve forward, backward, lateral and diagonal movements on a 250cm long mat with 25cm square grids. In a group setting, an instructor will demonstrate walking patterns on a gridded mat to the participants and the participants must memorize and repeat the patterns on their own. This program has over 200 patterns that increase in difficulty from beginner to advanced. Eighty percent of the group must successfully complete the patterns to move onto the next pattern. Social engagement is encouraged.
Other Names:
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No Intervention: Usual-care wait-list control
This group will receive standard care and be invited to partake in the intervention after all assessments have been completed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite score from Cambridge Brain Sciences Cognitive Battery
Time Frame: Change from 0 to 12 weeks
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To assess global cognitive function.
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Change from 0 to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait variability (stride time) under dual-task conditions
Time Frame: Change from 0 to 12 weeks
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Gait variability is the stride-to-stride fluctuations of the way someone walks and will be calculated as the coefficient of variation of step length (SD/mean x100).
Measured with GAITRite system.
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Change from 0 to 12 weeks
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Gait variability (stride time) under single-task conditions
Time Frame: Change from 0 to 12 weeks
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Gait variability is the stride-to-stride fluctuations of the way someone walks and will be calculated as the coefficient of variation of step length (SD/mean x100).
Measured with GAITRite system (portable gait analysis).
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Change from 0 to 12 weeks
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Gait velocity (speed) under dual-task conditions
Time Frame: Change from 0 to 12 weeks
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Average walking speed (gait velocity) measured with the GAITRite system (portable gait analysis)
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Change from 0 to 12 weeks
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Gait velocity (speed) under single-task conditions
Time Frame: Change from 0 to 12 weeks
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Average walking speed (gait velocity) measured with the GAITRite system (portable gait analysis).
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Change from 0 to 12 weeks
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Step length (average) under dual-task conditions
Time Frame: Change from 0 to 12 weeks
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Mean step length calculated from GAITRite system (portable gait analysis).
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Change from 0 to 12 weeks
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Step length (average) under single-task conditions
Time Frame: Change from 0 to 12 weeks
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Mean step length calculated from GAITRite system (portable gait analysis).
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Change from 0 to 12 weeks
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Memory composite score
Time Frame: Change from 0 to 12 weeks
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Measured by Cambridge Brain Sciences - composite score from 4 memory tasks
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Change from 0 to 12 weeks
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Reasoning composite score
Time Frame: Change from 0 to 12 weeks
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Measured by Cambridge Brain Sciences - composite score from 3 reasoning tasks
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Change from 0 to 12 weeks
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Concentration composite score
Time Frame: Change from 0 to 12 weeks
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Measured by Cambridge Brain Sciences - composite score from 3 concentration tasks
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Change from 0 to 12 weeks
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Planning (executive functioning) composite score
Time Frame: Change from 0 to 12 weeks
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Measured by Cambridge Brain Sciences - composite score from 2 planning (executive function) tasks
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Change from 0 to 12 weeks
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Short Performance Physical Battery - Balance
Time Frame: Change from 0 to 12 weeks
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To assess balance measured by Side by Side Stand, Semi-Tandem Stand, Tandem Stand to obtain a balance test score.
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Change from 0 to 12 weeks
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Neuropsychiatric Inventory Questionnaire
Time Frame: change from 0 to 12 weeks
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To assess behavioural changes in residents with dementia
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change from 0 to 12 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Robert Petrella, MD, PhD, Western University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10012765
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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