Cognitive Ability, GeneralNCT02136368
Body and Brain Exercise for Older Adults With Memory Complaints
A study testing Multi-modal exercise, Mind-Motor Exercise and Balance and range of motion exercises in people with Cognitive Ability, General, 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 investigate whether an exercise class with a cognitive (or brain) training component was more effective than a usual combined aerobic and resistance exercise class for older adults with cognitive complaints (such as concerns about changes in memory or thinking skills). Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Ability, General
- What is being tested?
- Multi-modal exercise, Mind-Motor Exercise and Balance and range of motion exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Mar 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 55 years or older
- self-reported cognitive complaint (defined as answering yes to the question "Do you feel like your memory or thinking skills have gotten worse recently?).
- independent on instrumental activities of daily living
Who cannot join
- Probable Dementia (i.e., diagnosis OR Mini-Mental State Examination score <24)
- Other neurological conditions or major psychiatric disorders (i.e., Parkinson's disease; bipolar disorder)
- Previous history of severe cardiovascular conditions (i.e., myocardial infarction or stroke <1-year ago; end stage congestive heart failure; end stage renal disease)
- Severe sensory impairment (i.e., blind)
- Significant orthopedic conditions (i.e., severe osteoarthritis)
- Clinical depression (determined via >=16 on the Center for Epidemiologic Studies - Depression Scale AND review by primary study physician)
Show all 9Show fewer
- Have blood pressure >180/100 mmHg or <100/60 mmHg
- Unable to comprehend questionnaire material
- Any other factors that could potentially limit ability to fully participate in the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Combined Exercise Program Plus Cognitive Training for Older Adults With Self-reported Cognitive Complaints: The Multi-modal, Mind-motor (M4) Study
The purpose of this study is to investigate whether an exercise class with a cognitive (or brain) training component was more effective than a usual combined aerobic and resistance exercise class for older adults with cognitive complaints (such as concerns about changes in memory or thinking skills). It is hypothesized that the group randomized to the exercise class that includes additional brain training will have greater improvements in brain health.
Read the detailed description
Older adults with self-reported cognitive complaints (CCs) may be at increased risk for the development of Alzheimer's disease and dementia. Cognitive decline in older adults, particularly reduced memory and executive function is associated with functional decline, institutionalization, and increased health care costs. Similarly, cardiovascular risk factors have been associated with cognitive and functional impairment in aging. Aerobic exercise has been shown to improve vascular function and blood flow in the brain's prefrontal cortex. In turn, resistance training can produce functional changes within distinct cortical regions during the encoding and recall of association tasks and has been shown to increase circulating neural growth factors (i.e., a proposed mechanism by which cognition may be preserved or improved in old age). Recent evidence also suggests that cognitive training may improve the cognitive performance of older adults.
Therefore, we will investigate the impact of a combined exercise program (multi-modality exercise; M2) compared to a combined exercise program with a cognitive component (multi-modality, mind-motor exercise; M4) on cognition, cognitive-motor, mobility, neural functioning and vascular outcomes in older adults with cognitive complaints. Community-based exercise programs for older adults provide widespread access, are relatively inexpensive, and provide opportunities for social interaction.
The primary purpose of this study is to compare the effects of the M2 and M4 exercise programs on brain health. This study will also examine the effects of the different exercise programs on cardiovascular risk factors and mobility. In a subset of participants, cognitive-motor and neural functioning outcomes will be examined.
- Conditions
- Cognitive Ability, General
- Being tested
- Multi-modal exercise, Mind-Motor Exercise, Balance and range of motion exercises
- Keywords
- older adults, multiple-modality exercise, mind-motor exercise, self-reported cognitive complaints, global cognitive functioning, mobility, vascular function, sensorimotor function, brain imaging, community-based research, subjective cognitive complaints
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-modal exerciseBehavioural
Also called Exercise intervention
Community-based group exercise classes following Canadian Centre for Activity and Aging exercise guidelines. Exercise classes consist of 5 min warm-up, 20 min aerobic exercise, 5 min aerobic cool-down, 10 min full-body resistance exercise, 5 min stretching (total 45 min)
Mind-Motor ExerciseBehavioural
Also called Square Stepping Exercise
Square Step 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 (15 min).
Balance and range of motion exercisesBehavioural
Community-based group exercise designed to improve balance and range of motion of the joints (15 min)
| Study group | Role | What they receive |
|---|---|---|
| Multi-Modal, Mind Motor Exercise (M4) | Experimental | Attend 60 minute exercise class three times per week for 24 weeks. Exercise class includes 45 minutes of multi-modal exercise and 15 minutes of mind-motor exercise. Receives: Behavioral: Multi-modal exercise; Behavioral: Mind-Motor Exercise |
| Multi-Modal Exercise (M2) | Active comparator | Attend 60 minute exercise class three times per week for 24 weeks. Exercise class includes 45 minutes of multi-modal exercise and 15 minutes of balance and range of motion exercises. Receives: Behavioral: Multi-modal exercise; Behavioral: Balance and range of motion exercises |
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 - 12 tasks
To assess global cognitive function
Measured: 6 months
Secondary outcomes (17)
Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks
To assess global cognitive function
Measured: 12 months
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: 6 & 12 months
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.
Measured: 6 & 12 months
Gait velocity (speed) under dual-task conditions
Average walking speed (gait velocity) measured with the GAITRite system
Measured: 6 & 12 months
Gait velocity (speed) under single-task conditions
Average walking speed (gait velocity) measured with the GAITRite system
Measured: 6 & 12 months
Step length (average) under dual-task conditions
Mean step length calculated from GAITRite system
Measured: 6 & 12 months
Step length (average) under single-task conditions
Mean step length calculated from GAITRite system
Measured: 6 & 12 months
Carotid Artery Compliance
Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck).
Measured: 6 & 12 months
Carotid Artery Intima-media thickness
Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck).
Measured: 6 & 12 months
Ambulatory Systolic Blood Pressure
Average systolic blood pressure over a 24 hour time period.
Measured: 6 & 12 months
Clinic Systolic Blood Pressure
Average systolic blood pressure from in clinic final 2 (out of 3) readings
Measured: 6 & 12 months
Ambulatory Diastolic Blood Pressure
Average diastolic blood pressure over a 24 hour time period.
Measured: 6 & 12 months
Clinic Diastolic Blood Pressure
Average diastolic blood pressure from in clinic final 2 (out of 3) readings
Measured: 6 & 12 months
Composite score of memory tasks from Cambridge Brain Sciences Cognitive Battery
Measured: 6 & 12 months
Composite score of executive function tasks from Cambridge Brain Sciences Cognitive Battery
Measured: 6 & 12 months
Composite score of concentration tasks from Cambridge Brain Sciences Cognitive Battery
Measured: 6 & 12 months
Total balance score
Total score calculated from the the Fullerton Advanced Balance scale
Measured: 6 & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive Ability, GeneralStudies 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
- 127 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
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- 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, The University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136368
- Sponsor's protocol ID
- M4W18858
- Status last verified
- Sep 2016
- First submitted
- 29 Apr 2014
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Boa Sorte Silva NC, Nagamatsu LS, Gill DP, Owen AM, Petrella RJ. Memory Function and Brain Functional Connectivity Adaptations Following Multiple-Modality Exercise and Mind-Motor Training in Older Adults at Risk of Dementia: An Exploratory Sub-Study. Front Aging Neurosci. 2020 Feb 25;12:22. doi: 10.3389/fnagi.2020.00022. eCollection 2020.
PubMed 32158386Gregory MA, Gill DP, Shellington EM, Liu-Ambrose T, Shigematsu R, Zou G, Shoemaker K, Owen AM, Hachinski V, Stuckey M, Petrella RJ. Group-based exercise and cognitive-physical training in older adults with self-reported cognitive complaints: The Multiple-Modality, Mind-Motor (M4) study protocol. BMC Geriatr. 2016 Jan 16;16:17. doi: 10.1186/s12877-016-0190-9.
PubMed 26772171
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Exercise Program Plus Cognitive Training for Older Adults With Self-reported Cognitive Complaints: The Multi-modal, Mind-motor (M4) Study
- ClinicalTrials.gov ID
- NCT02136368
- Acronym / sponsor ID
- M4W18858
- Conditions
- Cognitive Ability, General
- Keywords
- older adults, multiple-modality exercise, mind-motor exercise, self-reported cognitive complaints, global cognitive functioning, mobility, vascular function, sensorimotor function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 May 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 investigate whether an exercise class with a cognitive (or brain) training component was more effective than a usual combined aerobic and resistance exercise class for older adults with cognitive complaints (such as concerns about changes in memory or thinking skills). It is hypothesized that the group randomized to the exercise class that includes additional brain training will have greater improvements in brain health.
Detailed description
Older adults with self-reported cognitive complaints (CCs) may be at increased risk for the development of Alzheimer's disease and dementia. Cognitive decline in older adults, particularly reduced memory and executive function is associated with functional decline, institutionalization, and increased health care costs. Similarly, cardiovascular risk factors have been associated with cognitive and functional impairment in aging. Aerobic exercise has been shown to improve vascular function and blood flow in the brain's prefrontal cortex. In turn, resistance training can produce functional changes within distinct cortical regions during the encoding and recall of association tasks and has been shown to increase circulating neural growth factors (i.e., a proposed mechanism by which cognition may be preserved or improved in old age). Recent evidence also suggests that cognitive training may improve the cognitive performance of older adults.
Therefore, we will investigate the impact of a combined exercise program (multi-modality exercise; M2) compared to a combined exercise program with a cognitive component (multi-modality, mind-motor exercise; M4) on cognition, cognitive-motor, mobility, neural functioning and vascular outcomes in older adults with cognitive complaints. Community-based exercise programs for older adults provide widespread access, are relatively inexpensive, and provide opportunities for social interaction.
The primary purpose of this study is to compare the effects of the M2 and M4 exercise programs on brain health. This study will also examine the effects of the different exercise programs on cardiovascular risk factors and mobility. In a subset of participants, cognitive-motor and neural functioning outcomes will be examined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-Modal, Mind Motor Exercise (M4) | Experimental | Behavioral: Multi-modal exercise, Behavioral: Mind-Motor ExerciseAttend 60 minute exercise class three times per week for 24 weeks. Exercise class includes 45 minutes of multi-modal exercise and 15 minutes of mind-motor exercise. |
| Multi-Modal Exercise (M2) | Active comparator | Behavioral: Multi-modal exercise, Behavioral: Balance and range of motion exercisesAttend 60 minute exercise class three times per week for 24 weeks. Exercise class includes 45 minutes of multi-modal exercise and 15 minutes of balance and range of motion exercises. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 55 years or older
- self-reported cognitive complaint (defined as answering yes to the question "Do you feel like your memory or thinking skills have gotten worse recently?).
- independent on instrumental activities of daily living
Key exclusion criteria (9 listed)
- Probable Dementia (i.e., diagnosis OR Mini-Mental State Examination score <24)
- Other neurological conditions or major psychiatric disorders (i.e., Parkinson's disease; bipolar disorder)
- Previous history of severe cardiovascular conditions (i.e., myocardial infarction or stroke <1-year ago; end stage congestive heart failure; end stage renal disease)
- Severe sensory impairment (i.e., blind)
- Significant orthopedic conditions (i.e., severe osteoarthritis)
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 |
|---|---|---|
| Multi-modal exerciseAlso: Exercise interventionCommunity-based group exercise classes following Canadian Centre for Activity and Aging exercise guidelines. Exercise classes consist of 5 min warm-up, 20 min aerobic exercise, 5 min aerobic cool-down, 10 min full-body resistance exercise, 5 min stretching (total 45 min) | Behavioural | Multi-Modal Exercise (M2), Multi-Modal, Mind Motor Exercise (M4) |
| Mind-Motor ExerciseAlso: Square Stepping ExerciseSquare Step 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 (15 min). | Behavioural | Multi-Modal, Mind Motor Exercise (M4) |
| Balance and range of motion exercisesCommunity-based group exercise designed to improve balance and range of motion of the joints (15 min) | Behavioural | Multi-Modal Exercise (M2) |
Primary outcome
Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks
Time frame: 6 months
To assess global cognitive function
17 secondary outcomes
Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks
Time frame: 12 months
Gait variability (stride time) under dual-task conditions
Time frame: 6 & 12 months
Gait variability (stride time) under single-task conditions
Time frame: 6 & 12 months
Gait velocity (speed) under dual-task conditions
Time frame: 6 & 12 months
Gait velocity (speed) under single-task conditions
Time frame: 6 & 12 months
Step length (average) under dual-task conditions
Time frame: 6 & 12 months
Step length (average) under single-task conditions
Time frame: 6 & 12 months
Carotid Artery Compliance
Time frame: 6 & 12 months
Carotid Artery Intima-media thickness
Time frame: 6 & 12 months
Ambulatory Systolic Blood Pressure
Time frame: 6 & 12 months
Clinic Systolic Blood Pressure
Time frame: 6 & 12 months
Ambulatory Diastolic Blood Pressure
Time frame: 6 & 12 months
Clinic Diastolic Blood Pressure
Time frame: 6 & 12 months
Composite score of memory tasks from Cambridge Brain Sciences Cognitive Battery
Time frame: 6 & 12 months
Composite score of executive function tasks from Cambridge Brain Sciences Cognitive Battery
Time frame: 6 & 12 months
Composite score of concentration tasks from Cambridge Brain Sciences Cognitive Battery
Time frame: 6 & 12 months
Total balance score
Time frame: 6 & 12 months
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 Sep 2016.
- Derived from this study: PubMed 32158386Boa Sorte Silva NC, Nagamatsu LS, Gill DP, Owen AM, Petrella RJ. Memory Function and Brain Functional Connectivity Adaptations Following Multiple-Modality Exercise and Mind-Motor Training in Older Adults at Risk of Dementia: An Exploratory Sub-Study. Front Aging Neurosci. 2020 Feb 25;12:22. doi: 10.3389/fnagi.2020.00022. eCollection 2020.
- Derived from this study: PubMed 26772171Gregory MA, Gill DP, Shellington EM, Liu-Ambrose T, Shigematsu R, Zou G, Shoemaker K, Owen AM, Hachinski V, Stuckey M, Petrella RJ. Group-based exercise and cognitive-physical training in older adults with self-reported cognitive complaints: The Multiple-Modality, Mind-Motor (M4) study protocol. BMC Geriatr. 2016 Jan 16;16:17. doi: 10.1186/s12877-016-0190-9.
- 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
The University of Western Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-modal exercise, Mind-Motor Exercise and Balance and range of motion exercises in people with Cognitive Ability, General, 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 9 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 Sep 2016. 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 - 12 tasks (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02136368, which also lists 2 linked publications.
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 Sep 2016; AzTrials last refreshed its copy on 5 Nov 2026.