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Body and Brain Exercise for Older Adults With Memory Complaints

A Combined Exercise Program Plus Cognitive Training for Older Adults With Self-reported Cognitive Complaints: The Multi-modal, Mind-motor (M4) Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02136368
Enrollment
127
Registered
2014-05-13
Start date
2014-01-31
Completion date
2016-03-31
Last updated
2016-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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, brain imaging, community-based research, subjective cognitive complaints

Brief 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). 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.

Interventions

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)

BEHAVIORALMind-Motor 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).

BEHAVIORALBalance and range of motion exercises

Community-based group exercise designed to improve balance and range of motion of the joints (15 min)

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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) * 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

Design outcomes

Primary

MeasureTime frameDescription
Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks6 monthsTo assess global cognitive function

Secondary

MeasureTime frameDescription
Carotid Artery Compliance6 & 12 monthsMeasured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck).
Composite score of memory tasks from Cambridge Brain Sciences Cognitive Battery6 & 12 months
Composite score of executive function tasks from Cambridge Brain Sciences Cognitive Battery6 & 12 months
Composite score of concentration tasks from Cambridge Brain Sciences Cognitive Battery6 & 12 months
Total balance score6 & 12 monthsTotal score calculated from the the Fullerton Advanced Balance scale
Gait variability (stride time) under single-task conditions6 & 12 monthsGait 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.
Gait velocity (speed) under dual-task conditions6 & 12 monthsAverage walking speed (gait velocity) measured with the GAITRite system
Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks12 monthsTo assess global cognitive function
Gait variability (stride time) under dual-task conditions6 & 12 monthsGait 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.
Gait velocity (speed) under single-task conditions6 & 12 monthsAverage walking speed (gait velocity) measured with the GAITRite system
Step length (average) under dual-task conditions6 & 12 monthsMean step length calculated from GAITRite system
Step length (average) under single-task conditions6 & 12 monthsMean step length calculated from GAITRite system
Carotid Artery Intima-media thickness6 & 12 monthsMeasured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck).
Ambulatory Systolic Blood Pressure6 & 12 monthsAverage systolic blood pressure over a 24 hour time period.
Clinic Systolic Blood Pressure6 & 12 monthsAverage systolic blood pressure from in clinic final 2 (out of 3) readings
Ambulatory Diastolic Blood Pressure6 & 12 monthsAverage diastolic blood pressure over a 24 hour time period.
Clinic Diastolic Blood Pressure6 & 12 monthsAverage diastolic blood pressure from in clinic final 2 (out of 3) readings

Other

MeasureTime frameDescription
Antisaccade reaction time in response to flash of light.6 monthsThe reaction time of the eye when instructed to look away from a flash of light.
Change in blood flow to the parietal cortex in response to a randomly selected cognitive task.6 monthsNeuroimaging assessment with functional magnetic resonance imaging
Change in blood flow to the pre-frontal cortex in response to a randomly selected cognitive task.6 monthsNeuroimaging assessment with functional magnetic resonance imaging
Prosaccade reaction time in response to flash of light.6 monthsThe reaction time of the eye when instructed to look toward a flash of light.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026