Cognitive DeclineMIND-FUNNCT02730013
Mind-motor Exercise to Improve Cognition and Functional Fitness
A study testing Square Stepping Exercise in people with Cognitive Decline, run by University of Western Ontario, Canada at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- Square Stepping Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteCanada
- Study dates
- May 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All residents of the 4 Schlegel Villages: Glendale Crossing, St. Clair, Tansley Woods, Winston Park
- Both males and females
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Western Centre for Public Health and Family Medicine, Western University
London, Ontario, N6G 2M1
About this study
Official title: 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.
Read the 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.
- Conditions
- Cognitive Decline
- Being tested
- Square Stepping Exercise
- Keywords
- Older adults, Square stepping exercise, Mind-motor exercise, Long-term care, Global cognitive functioning
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Square Stepping ExerciseBehavioural
Also called Mind-motor 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.
| Study group | Role | What they receive |
|---|---|---|
| Square Stepping Exercise | Experimental | 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. Receives: Behavioral: Square Stepping Exercise |
| Usual-care wait-list control | No intervention | This group will receive standard care and be invited to partake in the intervention after all assessments have been completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite score from Cambridge Brain Sciences Cognitive Battery
To assess global cognitive function.
Measured: Change from 0 to 12 weeks
Secondary outcomes (12)
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.
Measured: Change from 0 to 12 weeks
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).
Measured: Change from 0 to 12 weeks
Gait velocity (speed) under dual-task conditions
Average walking speed (gait velocity) measured with the GAITRite system (portable gait analysis)
Measured: Change from 0 to 12 weeks
Gait velocity (speed) under single-task conditions
Average walking speed (gait velocity) measured with the GAITRite system (portable gait analysis).
Measured: Change from 0 to 12 weeks
Step length (average) under dual-task conditions
Mean step length calculated from GAITRite system (portable gait analysis).
Measured: Change from 0 to 12 weeks
Step length (average) under single-task conditions
Mean step length calculated from GAITRite system (portable gait analysis).
Measured: Change from 0 to 12 weeks
Memory composite score
Measured by Cambridge Brain Sciences - composite score from 4 memory tasks
Measured: Change from 0 to 12 weeks
Reasoning composite score
Measured by Cambridge Brain Sciences - composite score from 3 reasoning tasks
Measured: Change from 0 to 12 weeks
Concentration composite score
Measured by Cambridge Brain Sciences - composite score from 3 concentration tasks
Measured: Change from 0 to 12 weeks
Planning (executive functioning) composite score
Measured by Cambridge Brain Sciences - composite score from 2 planning (executive function) tasks
Measured: Change from 0 to 12 weeks
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.
Measured: Change from 0 to 12 weeks
Neuropsychiatric Inventory Questionnaire
To assess behavioural changes in residents with dementia
Measured: change from 0 to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Schlegel Villages: Retirement Homes and Long Term Care, University of Waterloo Research Institute for Aging
- Responsible party
- Sponsor
- Investigators
- Robert Petrella, MD, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730013
- Sponsor's protocol ID
- 10012765
- Acronym
- MIND-FUN
- Status last verified
- Sep 2017
- First submitted
- 31 Mar 2016
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MIND-FUN Research Study: Mind-motor Exercise to Improve Cognition and Functional Fitness
- ClinicalTrials.gov ID
- NCT02730013
- Acronym / sponsor ID
- MIND-FUN / 10012765
- Conditions
- Cognitive Decline
- Keywords
- Older adults, Square stepping exercise, Mind-motor exercise, Long-term care, Global cognitive functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Collaborators
- Schlegel Villages: Retirement Homes and Long Term Care, University of Waterloo Research Institute for Aging
- Study start
- May 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Square Stepping Exercise | Experimental | Behavioral: Square Stepping ExerciseSquare-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. |
| Usual-care wait-list control | No intervention | –This group will receive standard care and be invited to partake in the intervention after all assessments have been completed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All residents of the 4 Schlegel Villages: Glendale Crossing, St. Clair, Tansley Woods, Winston Park
- Both males and females
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Square Stepping ExerciseAlso: Mind-motor exerciseSquare 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. | Behavioural | Square Stepping Exercise |
Primary outcome
Composite score from Cambridge Brain Sciences Cognitive Battery
Time frame: Change from 0 to 12 weeks
To assess global cognitive function.
12 secondary outcomes
Gait variability (stride time) under dual-task conditions
Time frame: Change from 0 to 12 weeks
Gait variability (stride time) under single-task conditions
Time frame: Change from 0 to 12 weeks
Gait velocity (speed) under dual-task conditions
Time frame: Change from 0 to 12 weeks
Gait velocity (speed) under single-task conditions
Time frame: Change from 0 to 12 weeks
Step length (average) under dual-task conditions
Time frame: Change from 0 to 12 weeks
Step length (average) under single-task conditions
Time frame: Change from 0 to 12 weeks
Memory composite score
Time frame: Change from 0 to 12 weeks
Reasoning composite score
Time frame: Change from 0 to 12 weeks
Concentration composite score
Time frame: Change from 0 to 12 weeks
Planning (executive functioning) composite score
Time frame: Change from 0 to 12 weeks
Short Performance Physical Battery - Balance
Time frame: Change from 0 to 12 weeks
Neuropsychiatric Inventory Questionnaire
Time frame: change from 0 to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Petrella, MD, PhD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Square Stepping Exercise in people with Cognitive Decline, run by University of Western Ontario, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite score from Cambridge Brain Sciences Cognitive Battery (time frame: Change from 0 to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.