Clinical trial NCT02730013: Mind-motor Exercise to Improve Cognition and Functional Fitness
Official title: The MIND-FUN Research Study: Mind-motor Exercise to Improve Cognition and Functional Fitness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Keywords: Older adults
Square stepping exercise
Mind-motor exercise
Long-term care
Global cognitive functioning
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: Schlegel Villages: Retirement Homes and Long Term Care
name: University of Waterloo Research Institute for Aging
First posted: 2016-04-06
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Composite score from Cambridge Brain Sciences Cognitive Battery
timeFrame: Change from 0 to 12 weeks
Secondary outcomes:
measure: Gait variability (stride time) under dual-task conditions
timeFrame: Change from 0 to 12 weeks
measure: Gait variability (stride time) under single-task conditions
timeFrame: Change from 0 to 12 weeks
measure: Gait velocity (speed) under dual-task conditions
timeFrame: Change from 0 to 12 weeks
measure: Gait velocity (speed) under single-task conditions
timeFrame: Change from 0 to 12 weeks
measure: Step length (average) under dual-task conditions
timeFrame: Change from 0 to 12 weeks
measure: Step length (average) under single-task conditions
timeFrame: Change from 0 to 12 weeks
measure: Memory composite score
timeFrame: Change from 0 to 12 weeks
measure: Reasoning composite score
timeFrame: Change from 0 to 12 weeks
measure: Concentration composite score
timeFrame: Change from 0 to 12 weeks
measure: Planning (executive functioning) composite score
timeFrame: Change from 0 to 12 weeks
measure: Short Performance Physical Battery - Balance
timeFrame: Change from 0 to 12 weeks
measure: Neuropsychiatric Inventory Questionnaire
timeFrame: change from 0 to 12 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: Western Centre for Public Health and Family Medicine, Western University
state: Ontario
Study officials:
affiliation: Western University
name: Robert Petrella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: