Body and Brain Exercise for Older Adults With Memory Complaints

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cognitive Ability, General

Intervention / Treatment
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* Behavioral: Multi-modal exercise
* Behavioral: Mind-Motor Exercise
* Behavioral: Balance and range of motion exercises


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-Modal, Mind Motor Exercise (M4)<br>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. | Behavioral: Multi-modal exercise<br>* 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)<br>* Other names: Exercise intervention;Behavioral: Mind-Motor Exercise<br>* 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).<br>* Other names: Square Stepping Exercise;|
| Active Comparator: Multi-Modal Exercise (M2)<br>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. | Behavioral: Multi-modal exercise<br>* 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)<br>* Other names: Exercise intervention;Behavioral: Balance and range of motion exercises<br>* Community-based group exercise designed to improve balance and range of motion of the joints (15 min)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks | To assess global cognitive function | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite score from Cambridge Brain Sciences Cognitive Battery - 12 tasks | To assess global cognitive function | 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. | 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. | 6 & 12 months | 
| Gait velocity (speed) under dual-task conditions | Average walking speed (gait velocity) measured with the GAITRite system | 6 & 12 months | 
| Gait velocity (speed) under single-task conditions | Average walking speed (gait velocity) measured with the GAITRite system | 6 & 12 months | 
| Step length (average) under dual-task conditions | Mean step length calculated from GAITRite system | 6 & 12 months | 
| Step length (average) under single-task conditions | Mean step length calculated from GAITRite system | 6 & 12 months | 
| Carotid Artery Compliance | Measured from non-invasive vascular assessment with B-mode Ultrasound over the carotid artery (in the neck). | 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). | 6 & 12 months | 
| Ambulatory Systolic Blood Pressure | Average systolic blood pressure over a 24 hour time period. | 6 & 12 months | 
| Clinic Systolic Blood Pressure | Average systolic blood pressure from in clinic final 2 (out of 3) readings | 6 & 12 months | 
| Ambulatory Diastolic Blood Pressure | Average diastolic blood pressure over a 24 hour time period. | 6 & 12 months | 
| Clinic Diastolic Blood Pressure | Average diastolic blood pressure from in clinic final 2 (out of 3) readings | 6 & 12 months | 
| Composite score of memory tasks from Cambridge Brain Sciences Cognitive Battery |  | 6 & 12 months | 
| Composite score of executive function tasks from Cambridge Brain Sciences Cognitive Battery |  | 6 & 12 months | 
| Composite score of concentration tasks from Cambridge Brain Sciences Cognitive Battery |  | 6 & 12 months | 
| Total balance score | Total score calculated from the the Fullerton Advanced Balance scale | 6 & 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sensorimotor function, brain imaging, older adults, multiple-modality exercise, mind-motor exercise, self-reported cognitive complaints, global cognitive functioning, mobility, vascular function, community-based research, subjective cognitive complaints