Mind-motor Exercise to Improve Cognition and Functional Fitness

Cognitive Decline Clinical Trial

— MIND-FUN  

Official title:

The MIND-FUN Research Study: Mind-motor Exercise to Improve Cognition and Functional Fitness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730013
• Other study ID #: 10012765
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: October 2016

Study information

• Verified date: September 2017
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction

Intervention

Behavioral:
• Square Stepping Exercise
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.

Locations

Country	Name	City	State
Canada	Western Centre for Public Health and Family Medicine, Western University	London	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Western Ontario, Canada	Schlegel Villages: Retirement Homes and Long Term Care, University of Waterloo Research Institute for Aging

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite score from Cambridge Brain Sciences Cognitive Battery	To assess global cognitive function.	Change from 0 to 12 weeks
Secondary	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.	Change from 0 to 12 weeks
Secondary	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).	Change from 0 to 12 weeks
Secondary	Gait velocity (speed) under dual-task conditions	Average walking speed (gait velocity) measured with the GAITRite system (portable gait analysis)	Change from 0 to 12 weeks
Secondary	Gait velocity (speed) under single-task conditions	Average walking speed (gait velocity) measured with the GAITRite system (portable gait analysis).	Change from 0 to 12 weeks
Secondary	Step length (average) under dual-task conditions	Mean step length calculated from GAITRite system (portable gait analysis).	Change from 0 to 12 weeks
Secondary	Step length (average) under single-task conditions	Mean step length calculated from GAITRite system (portable gait analysis).	Change from 0 to 12 weeks
Secondary	Memory composite score	Measured by Cambridge Brain Sciences - composite score from 4 memory tasks	Change from 0 to 12 weeks
Secondary	Reasoning composite score	Measured by Cambridge Brain Sciences - composite score from 3 reasoning tasks	Change from 0 to 12 weeks
Secondary	Concentration composite score	Measured by Cambridge Brain Sciences - composite score from 3 concentration tasks	Change from 0 to 12 weeks
Secondary	Planning (executive functioning) composite score	Measured by Cambridge Brain Sciences - composite score from 2 planning (executive function) tasks	Change from 0 to 12 weeks
Secondary	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.	Change from 0 to 12 weeks
Secondary	Neuropsychiatric Inventory Questionnaire	To assess behavioural changes in residents with dementia	change from 0 to 12 weeks