Mind-motor Exercise to Improve Cognition and Functional Fitness (MIND-FUN)
Primary Purpose
Cognitive Decline
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Square Stepping Exercise
Sponsored by
About this trial
This is an interventional prevention trial for Cognitive Decline focused on measuring Older adults, Square stepping exercise, Mind-motor exercise, Long-term care, Global cognitive functioning
Eligibility Criteria
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).
Sites / Locations
- Western Centre for Public Health and Family Medicine, Western University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Square Stepping Exercise
Usual-care wait-list control
Arm Description
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.
This group will receive standard care and be invited to partake in the intervention after all assessments have been completed.
Outcomes
Primary Outcome Measures
Composite score from Cambridge Brain Sciences Cognitive Battery
To assess global cognitive function.
Secondary Outcome Measures
Gait variability (stride time) under dual-task conditions
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.
Gait variability (stride time) under single-task conditions
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).
Gait velocity (speed) under dual-task conditions
Average walking speed (gait velocity) measured with the GAITRite system (portable gait analysis)
Gait velocity (speed) under single-task conditions
Average walking speed (gait velocity) measured with the GAITRite system (portable gait analysis).
Step length (average) under dual-task conditions
Mean step length calculated from GAITRite system (portable gait analysis).
Step length (average) under single-task conditions
Mean step length calculated from GAITRite system (portable gait analysis).
Memory composite score
Measured by Cambridge Brain Sciences - composite score from 4 memory tasks
Reasoning composite score
Measured by Cambridge Brain Sciences - composite score from 3 reasoning tasks
Concentration composite score
Measured by Cambridge Brain Sciences - composite score from 3 concentration tasks
Planning (executive functioning) composite score
Measured by Cambridge Brain Sciences - composite score from 2 planning (executive function) tasks
Short Performance Physical Battery - Balance
To assess balance measured by Side by Side Stand, Semi-Tandem Stand, Tandem Stand to obtain a balance test score.
Neuropsychiatric Inventory Questionnaire
To assess behavioural changes in residents with dementia
Full Information
NCT ID
NCT02730013
First Posted
March 31, 2016
Last Updated
June 20, 2018
Sponsor
University of Western Ontario, Canada
Collaborators
Schlegel Villages: Retirement Homes and Long Term Care, University of Waterloo Research Institute for Aging
1. Study Identification
Unique Protocol Identification Number
NCT02730013
Brief Title
Mind-motor Exercise to Improve Cognition and Functional Fitness
Acronym
MIND-FUN
Official Title
The MIND-FUN Research Study: Mind-motor Exercise to Improve Cognition and Functional Fitness
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Western Ontario, Canada
Collaborators
Schlegel Villages: Retirement Homes and Long Term Care, University of Waterloo Research Institute for Aging
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a 3 month cluster randomized controlled trial using a square-stepping exercise program (a.k.a. mind-motor exercise) in retirement and long-term care residences to improve global cognitive functioning in older adults with and without cognitive impairments. The investigators intend this project to be pragmatic and therefore will include residents with dementia and walking aids if the participants wish to participate. The primary outcome is global cognitive functioning, secondary outcomes include: single and dual task gait (only completed with those without dementia), oculomotor functioning, and functional fitness. The investigators hypothesize that there will be improvements in primary and secondary outcomes in the intervention group.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline
Keywords
Older adults, Square stepping exercise, Mind-motor exercise, Long-term care, Global cognitive functioning
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Square Stepping Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual-care wait-list control
Arm Type
No Intervention
Arm Description
This group will receive standard care and be invited to partake in the intervention after all assessments have been completed.
Intervention Type
Behavioral
Intervention Name(s)
Square Stepping Exercise
Other Intervention Name(s)
Mind-motor exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite score from Cambridge Brain Sciences Cognitive Battery
Description
To assess global cognitive function.
Time Frame
Change from 0 to 12 weeks
Secondary Outcome Measure Information:
Title
Gait variability (stride time) under dual-task conditions
Description
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.
Time Frame
Change from 0 to 12 weeks
Title
Gait variability (stride time) under single-task conditions
Description
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).
Time Frame
Change from 0 to 12 weeks
Title
Gait velocity (speed) under dual-task conditions
Description
Average walking speed (gait velocity) measured with the GAITRite system (portable gait analysis)
Time Frame
Change from 0 to 12 weeks
Title
Gait velocity (speed) under single-task conditions
Description
Average walking speed (gait velocity) measured with the GAITRite system (portable gait analysis).
Time Frame
Change from 0 to 12 weeks
Title
Step length (average) under dual-task conditions
Description
Mean step length calculated from GAITRite system (portable gait analysis).
Time Frame
Change from 0 to 12 weeks
Title
Step length (average) under single-task conditions
Description
Mean step length calculated from GAITRite system (portable gait analysis).
Time Frame
Change from 0 to 12 weeks
Title
Memory composite score
Description
Measured by Cambridge Brain Sciences - composite score from 4 memory tasks
Time Frame
Change from 0 to 12 weeks
Title
Reasoning composite score
Description
Measured by Cambridge Brain Sciences - composite score from 3 reasoning tasks
Time Frame
Change from 0 to 12 weeks
Title
Concentration composite score
Description
Measured by Cambridge Brain Sciences - composite score from 3 concentration tasks
Time Frame
Change from 0 to 12 weeks
Title
Planning (executive functioning) composite score
Description
Measured by Cambridge Brain Sciences - composite score from 2 planning (executive function) tasks
Time Frame
Change from 0 to 12 weeks
Title
Short Performance Physical Battery - Balance
Description
To assess balance measured by Side by Side Stand, Semi-Tandem Stand, Tandem Stand to obtain a balance test score.
Time Frame
Change from 0 to 12 weeks
Title
Neuropsychiatric Inventory Questionnaire
Description
To assess behavioural changes in residents with dementia
Time Frame
change from 0 to 12 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Petrella, MD, PhD
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Centre for Public Health and Family Medicine, Western University
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 2M1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mind-motor Exercise to Improve Cognition and Functional Fitness
We'll reach out to this number within 24 hrs