Type 2 Diabetes MellitusNCT02292511
Mind-motor Exercise in Older Adults With Type 2 Diabetes and Self-reported Cognitive Complaints
A study testing Square-stepping exercise in people with Type 2 Diabetes Mellitus, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The purpose of this study is to determine if a 6 month mind-motor intervention will help to improve overall brain health in adults over the age of 55 with type 2 diabetes and a self-reported complaint about memory or thinking skills. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- 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
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to Jun 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 years of age or older
- Stable type 2 diabetes (i.e. A1c <9.0 for at least 6 months)
- Self report a cognitive complaint (i.e answer yes to: do you feel your memory and/or thinking skills have gotten worse recently?)
Who cannot join
- Participants must be able to comprehend the letter of information and provide consent.
- Participants cannot have
- major depression, measured by Center of Epidemiologic Studies Depression Scale (CES-D) and study physician consult,
- diagnosis of dementia, or score <24 on mini-mental state examination (MMSE)
- other significant neurological disorder or psychiatric conditions
- severe history of cardiovascular events
Show all 13Show fewer
- severe orthopedic limitations
- uncontrolled diabetes (i.e A1c <4.0mmol/L or >9.0mmol/L)
- unstable angina
- untreated retinopathy
- foot ulcers with or without severe peripheral neuropathy
- severe sensory impairment (i.e. blind).
- Finally, participants must plan to attend at least 75% of the sessions over the 24-week period; this is to ensure adequate compliance of the program.
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Joseph's Primary Care Diabetes Support Program
London, Ontario
About this study
The purpose of this study is to determine if a 6 month mind-motor intervention will help to improve overall brain health in adults over the age of 55 with type 2 diabetes and a self-reported complaint about memory or thinking skills. It is hypothesized that the intervention group will show improvements in their overall brain health after 6 months of mind-motor training compared to the control group.
Read the detailed description
Dementia has been identified as a global health concern because of the increase in incidence globally. Regardless of whether individuals with self-reported cognitive complaints (CCs) have objective impairment, they are at increased risk for cognitive decline, and they are comparable to those with early mild cognitive impairment (MCI) for brain atrophy and increased risk of progression towards Alzheimer's disease (AD). People who express being worried about their memory or cognition show a further increased risk of cognitive decline. If prevention programs could delay the onset of dementia even in part of the at-risk population, this could decrease disease prevalence significantly. The risk of cognitive impairment or dementia is increased in type 2 diabetes (T2D) and T2D accelerates the progression from MCI to dementia.
The proposed mind-motor intervention for the prevention of cognitive decline in T2D is called square stepping exercise (SSE). The SSE program was developed by Shigematsu and Okura (2005) and can be best described as a visuospatial working memory task with a stepping response. There are more than 200 patterns developed for this program that progress from simple to advanced stepping patterns. The primary focus of Shigematsu and colleagues' research has been to examine the impact of SSE on fall risk factors and mobility in older adults. Within their research they have found that SSE improves lower extremity functional fitness, reduces fall risk, and improves overall fitness in older adults when compared to walking or strength and balance training. In combination with Dr. Shigematsu's research in Japan in healthy older adults, the investigators are aiming to provide a significant evidence base for SSE internationally and within varied populations, including older adults with subjective cognitive complaints and with different chronic diseases. In collaboration with Dr. Shigematsu, the investigators have executed SSE studies at the Canadian Centre for Activity and Aging and currently are running a study in the community in Woodstock, ON. Preliminary evidence has shown that over a 6-month exercise plus mind-motor training period, participants improved in global cognitive functioning, verbal learning and memory, and verbal fluency, when compared to an exercise control group. Most recently, Shigematsu and colleagues have found the SSE program to improve memory and executive function in a 6-month pilot study.
The overarching goal of the investigators is healthy aging; research goals aim to evaluate intervention tools in the prevention of cognitive decline at one of the earliest markers of cognitive decline, which is a subjective complaint. As well, goals of the intervention strategies are to maintain mobility and balance with advancing age and chronic disease. The T2D population is at increased risk of decline and the added component of self-management of diabetes and insulin treatment makes it crucial to maintain adequate cognition and independence in this population.
Study Design: This study will be a 24-week Proof-of-Concept randomized controlled trial (1:1 allocation) whereby consenting and eligible participants will be randomized to either: 1) the SSE intervention group or 2) a usual-care, wait-list control group. Participants will be recruited from the St. Joseph's Primary Care Diabetes Support Program (SJHC- PCDSP) and the study intervention will be conducted at a community location in London, Ontario. This will be a single blinded study. All assessments will be done pre-intervention (V0) and post-intervention (V2), with interim assessments after 12-weeks (V1) (with the exception of sensorimotor). Assessments will take place at SJHC-PCDSP and Western University. One assessment will be done online either at the participant's home or at SJHC-PCDSP (solely completed by the participant)(i.e. Cambridge Brain Sciences). We will use blocked randomization and thus, participants will begin and complete the trial within waves.
Participants: All participants will be required to self-report a cognitive complaint; once eligibility is determined, participants will then be asked further questions about their cognition. Participants will undergo a number of measurements at baseline, which will be used to describe the study sample. These measures include: i) baseline cognition: Montreal Cognitive Assessment (MoCA) and the Clock Drawing Test; ii) baseline fitness: Step test iii) Anthropometric measures: weight, height, waist circumference; iv) history of physical and mental activities: Leisure Activities questionnaire v) clinic blood work values HbA1c, creatine (eGFR), and lipid assessment obtained from clinic electronic medical records (EMR) and vi) demographic information. Current medications, blood pressure and patient medical history will also be obtained from EMRs.
Intervention SSE (Intervention) Group: Participants in the Square Stepping Exercise group will be doing a group-based mind-motor intervention program. Participants will come to a community location for 60 minutes on one day per week to participate in the SSE program. An instructor will be present to demonstrate the walking patterns on a gridded mat. Participants must memorize and complete the patterns as a group, and they are encouraged to help one another to promote social engagement. Eighty percent of the group must successfully complete the patterns to move on to the next pattern. There are over 200 patterns that increase in difficulty from beginner, to intermediate and advanced. If some participants are struggling to keep up with the group, a catch-up session will be made available to assist those participants. Participants will be asked to use the smartphone application (Healthebrain) 10 minutes per day or 2 patterns as homework to supplement the SSE program. Participants will be able to use their own smartphones (apple or android devices) or they will be given a smartphone to use for the duration of the study as needed.
Wait-List Control Group: The investigators have opted to use a wait-list control group for this study in order to see differences of our intervention from usual care in T2D.The control group will be on a wait list to participate in the 24-week SSE program, which will commence after all measurements are completed by both groups. The classes will be offered free of charge.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Square-stepping exercise
- Keywords
- subjective cognitive impairment, mind-motor intervention, square-stepping exercise, older adults
- Medical subject headings
- Diabetes Mellitus, Type 2
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
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 Intervention | Experimental | Participants in this group will attend a square-stepping exercise intervention 60 minutes on two days a week at a community location. 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.
Global Cognitive Functioning
measured by Cambridge Brain Sciences - composite score from 12 tasks
Measured: Change from 0 to 24 weeks
Secondary outcomes (10)
Global Cognitive Functioning
measured by Cambridge Brain Sciences - composite score from 12 tasks
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 & 24 weeks
Reasoning composite score
measured by Cambridge Brain Sciences - composite score from 3 reasoning tasks
Measured: Change from 0 to 12 & 24 weeks
Concentration composite score
measured by Cambridge Brain Sciences - composite score from 3 concentration tasks
Measured: Change from 0 to 12 & 24 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 & 24 weeks
Gait Speed
measured by 6 metre walk test
Measured: Change from 0 to 12 & 24 weeks
Prosaccade reaction time
measured by eye tracking - the reaction time of the eye when instructed to look toward a flash of light
Measured: Change from 0 to 24 weeks
Antisaccade reaction time
measured by eye tracking - the reaction time of the eye when instructed to look away from a flash of light
Measured: Change from 0 to 24 weeks
Prosaccade direction errors
measured by eye-tracking - the amount of eye movement error on trials
Measured: Change from 0 to 24 weeks
Antisaccade direction errors
measured by eye-tracking - the amount of eye movement error on trials
Measured: Change from 0 to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rob Petrella, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Robert J Petrella, MD, PhD, Principal investigator, University of Western Ontario, Lawson Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292511
- Sponsor's protocol ID
- D-SSE-123
- Status last verified
- Mar 2017
- First submitted
- 12 Nov 2014
- Last updated
- 7 Mar 2017
- 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 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind-motor Exercise in Older Adults With Type 2 Diabetes and Self-reported Cognitive Complaints
- ClinicalTrials.gov ID
- NCT02292511
- Acronym / sponsor ID
- D-SSE-123
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- subjective cognitive impairment, mind-motor intervention, square-stepping exercise, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Nov 2014 (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.
The purpose of this study is to determine if a 6 month mind-motor intervention will help to improve overall brain health in adults over the age of 55 with type 2 diabetes and a self-reported complaint about memory or thinking skills. It is hypothesized that the intervention group will show improvements in their overall brain health after 6 months of mind-motor training compared to the control group.
Detailed description
Dementia has been identified as a global health concern because of the increase in incidence globally. Regardless of whether individuals with self-reported cognitive complaints (CCs) have objective impairment, they are at increased risk for cognitive decline, and they are comparable to those with early mild cognitive impairment (MCI) for brain atrophy and increased risk of progression towards Alzheimer's disease (AD). People who express being worried about their memory or cognition show a further increased risk of cognitive decline. If prevention programs could delay the onset of dementia even in part of the at-risk population, this could decrease disease prevalence significantly. The risk of cognitive impairment or dementia is increased in type 2 diabetes (T2D) and T2D accelerates the progression from MCI to dementia.
The proposed mind-motor intervention for the prevention of cognitive decline in T2D is called square stepping exercise (SSE). The SSE program was developed by Shigematsu and Okura (2005) and can be best described as a visuospatial working memory task with a stepping response. There are more than 200 patterns developed for this program that progress from simple to advanced stepping patterns. The primary focus of Shigematsu and colleagues' research has been to examine the impact of SSE on fall risk factors and mobility in older adults. Within their research they have found that SSE improves lower extremity functional fitness, reduces fall risk, and improves overall fitness in older adults when compared to walking or strength and balance training. In combination with Dr. Shigematsu's research in Japan in healthy older adults, the investigators are aiming to provide a significant evidence base for SSE internationally and within varied populations, including older adults with subjective cognitive complaints and with different chronic diseases. In collaboration with Dr. Shigematsu, the investigators have executed SSE studies at the Canadian Centre for Activity and Aging and currently are running a study in the community in Woodstock, ON. Preliminary evidence has shown that over a 6-month exercise plus mind-motor training period, participants improved in global cognitive functioning, verbal learning and memory, and verbal fluency, when compared to an exercise control group. Most recently, Shigematsu and colleagues have found the SSE program to improve memory and executive function in a 6-month pilot study.
The overarching goal of the investigators is healthy aging; research goals aim to evaluate intervention tools in the prevention of cognitive decline at one of the earliest markers of cognitive decline, which is a subjective complaint. As well, goals of the intervention strategies are to maintain mobility and balance with advancing age and chronic disease. The T2D population is at increased risk of decline and the added component of self-management of diabetes and insulin treatment makes it crucial to maintain adequate cognition and independence in this population.
Study Design: This study will be a 24-week Proof-of-Concept randomized controlled trial (1:1 allocation) whereby consenting and eligible participants will be randomized to either: 1) the SSE intervention group or 2) a usual-care, wait-list control group. Participants will be recruited from the St. Joseph's Primary Care Diabetes Support Program (SJHC- PCDSP) and the study intervention will be conducted at a community location in London, Ontario. This will be a single blinded study. All assessments will be done pre-intervention (V0) and post-intervention (V2), with interim assessments after 12-weeks (V1) (with the exception of sensorimotor). Assessments will take place at SJHC-PCDSP and Western University. One assessment will be done online either at the participant's home or at SJHC-PCDSP (solely completed by the participant)(i.e. Cambridge Brain Sciences). We will use blocked randomization and thus, participants will begin and complete the trial within waves.
Participants: All participants will be required to self-report a cognitive complaint; once eligibility is determined, participants will then be asked further questions about their cognition. Participants will undergo a number of measurements at baseline, which will be used to describe the study sample. These measures include: i) baseline cognition: Montreal Cognitive Assessment (MoCA) and the Clock Drawing Test; ii) baseline fitness: Step test iii) Anthropometric measures: weight, height, waist circumference; iv) history of physical and mental activities: Leisure Activities questionnaire v) clinic blood work values HbA1c, creatine (eGFR), and lipid assessment obtained from clinic electronic medical records (EMR) and vi) demographic information. Current medications, blood pressure and patient medical history will also be obtained from EMRs.
Intervention SSE (Intervention) Group: Participants in the Square Stepping Exercise group will be doing a group-based mind-motor intervention program. Participants will come to a community location for 60 minutes on one day per week to participate in the SSE program. An instructor will be present to demonstrate the walking patterns on a gridded mat. Participants must memorize and complete the patterns as a group, and they are encouraged to help one another to promote social engagement. Eighty percent of the group must successfully complete the patterns to move on to the next pattern. There are over 200 patterns that increase in difficulty from beginner, to intermediate and advanced. If some participants are struggling to keep up with the group, a catch-up session will be made available to assist those participants. Participants will be asked to use the smartphone application (Healthebrain) 10 minutes per day or 2 patterns as homework to supplement the SSE program. Participants will be able to use their own smartphones (apple or android devices) or they will be given a smartphone to use for the duration of the study as needed.
Wait-List Control Group: The investigators have opted to use a wait-list control group for this study in order to see differences of our intervention from usual care in T2D.The control group will be on a wait list to participate in the 24-week SSE program, which will commence after all measurements are completed by both groups. The classes will be offered free of charge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Square-Stepping Exercise Intervention | Experimental | Behavioral: Square-stepping exerciseParticipants in this group will attend a square-stepping exercise intervention 60 minutes on two days a week at a community location. |
| 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
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50 years of age or older
- Stable type 2 diabetes (i.e. A1c <9.0 for at least 6 months)
- Self report a cognitive complaint (i.e answer yes to: do you feel your memory and/or thinking skills have gotten worse recently?)
Key exclusion criteria (13 listed)
- Participants must be able to comprehend the letter of information and provide consent.
- Participants cannot have
- major depression, measured by Center of Epidemiologic Studies Depression Scale (CES-D) and study physician consult,
- diagnosis of dementia, or score <24 on mini-mental state examination (MMSE)
- other significant neurological disorder or psychiatric conditions
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 exerciseIn 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 Intervention |
Primary outcome
Global Cognitive Functioning
Time frame: Change from 0 to 24 weeks
measured by Cambridge Brain Sciences - composite score from 12 tasks
10 secondary outcomes
Global Cognitive Functioning
Time frame: Change from 0 to 12 weeks
Memory composite score
Time frame: Change from 0 to 12 & 24 weeks
Reasoning composite score
Time frame: Change from 0 to 12 & 24 weeks
Concentration composite score
Time frame: Change from 0 to 12 & 24 weeks
Planning (executive functioning) composite score
Time frame: Change from 0 to 12 & 24 weeks
Gait Speed
Time frame: Change from 0 to 12 & 24 weeks
Prosaccade reaction time
Time frame: Change from 0 to 24 weeks
Antisaccade reaction time
Time frame: Change from 0 to 24 weeks
Prosaccade direction errors
Time frame: Change from 0 to 24 weeks
Antisaccade direction errors
Time frame: Change from 0 to 24 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 7 Mar 2017.
- 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 J Petrella, MD, PhD principal investigator
University of Western Ontario, Lawson Health Research Institute
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 Type 2 Diabetes Mellitus, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 3 inclusion and 13 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 7 Mar 2017. 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?
Global Cognitive Functioning (time frame: Change from 0 to 24 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 7 Mar 2017.