Mind-motor Exercise to Improve Cognition and Functional Fitness (MIND-FUN)

June 20, 2018 updated by: University of Western Ontario, Canada

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

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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • London, Ontario, Canada, N6G 2M1
        • Western Centre for Public Health and Family Medicine, Western University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

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:
  • Mind-motor exercise
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.

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
To assess global cognitive function.
Change from 0 to 12 weeks

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
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
Gait variability (stride time) under single-task conditions
Time Frame: Change from 0 to 12 weeks
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
Gait velocity (speed) under dual-task conditions
Time Frame: Change from 0 to 12 weeks
Average walking speed (gait velocity) measured with the GAITRite system (portable gait analysis)
Change from 0 to 12 weeks
Gait velocity (speed) under single-task conditions
Time Frame: Change from 0 to 12 weeks
Average walking speed (gait velocity) measured with the GAITRite system (portable gait analysis).
Change from 0 to 12 weeks
Step length (average) under dual-task conditions
Time Frame: Change from 0 to 12 weeks
Mean step length calculated from GAITRite system (portable gait analysis).
Change from 0 to 12 weeks
Step length (average) under single-task conditions
Time Frame: Change from 0 to 12 weeks
Mean step length calculated from GAITRite system (portable gait analysis).
Change from 0 to 12 weeks
Memory composite score
Time Frame: Change from 0 to 12 weeks
Measured by Cambridge Brain Sciences - composite score from 4 memory tasks
Change from 0 to 12 weeks
Reasoning composite score
Time Frame: Change from 0 to 12 weeks
Measured by Cambridge Brain Sciences - composite score from 3 reasoning tasks
Change from 0 to 12 weeks
Concentration composite score
Time Frame: Change from 0 to 12 weeks
Measured by Cambridge Brain Sciences - composite score from 3 concentration tasks
Change from 0 to 12 weeks
Planning (executive functioning) composite score
Time Frame: Change from 0 to 12 weeks
Measured by Cambridge Brain Sciences - composite score from 2 planning (executive function) tasks
Change from 0 to 12 weeks
Short Performance Physical Battery - Balance
Time Frame: Change from 0 to 12 weeks
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
Neuropsychiatric Inventory Questionnaire
Time Frame: change from 0 to 12 weeks
To assess behavioural changes in residents with dementia
change from 0 to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Robert Petrella, MD, PhD, Western University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

March 31, 2016

First Submitted That Met QC Criteria

March 31, 2016

First Posted (Estimate)

April 6, 2016

Study Record Updates

Last Update Posted (Actual)

June 25, 2018

Last Update Submitted That Met QC Criteria

June 20, 2018

Last Verified

September 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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