The Safety and Tolerability of an Aerobic and Resistance Exercise Program With Cognitive Training Post-stroke

Study Overview
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Brief Summary
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It is estimated that 2 out of 3 patients with a stroke have some problems with their memory, difficulties performing certain tasks, making decisions and learning new things. In addition, many stroke patients do not get regular exercise and are often sedentary. Both physical and cognitive exercise have the potential to improve quality of life, cognition, and overall health, but the safety and tolerability of such interventions is not clear in stroke patients. The investigators will examine these outcomes by allocating stroke survivor participants to one of two groups: a combined exercise and cognitive training program and a sham control group.

Detailed Description
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Stroke is well recognized as the leading cause of disability in the United States. Cognitive deficits after stroke are common, even in those without dementia prior to the event, and stroke patients with worse cognition on hospital admission have worse outcomes. Cognitive deficits contribute to stroke-related disability and mortality. Evidence suggests an interaction between cognitive deficits and physical limitations, and cognitive rehabilitation may improve functional outcomes post stroke. Recent data also suggest that both cognitive training and exercise interventions improve cognition in stroke patients, but few randomized trials of these interventions, alone or in combination, have been conducted. We will study the effects of a Combined Aerobic and Resistance Exercise Training (CARET) program and CTI interventions on the primary outcome of safety, feasibility, and adherence among ischemic or hemorrhagic stroke survivors with mild to moderate disability. We hypothesize that these interventions are safe and tolerable, and that they will lead to improvements in our secondary outcomes of cognitive performance and quality of life. We will also explore the role of Brain Derived Neurotrophic Factor in cognitive changes related to the physical exercise intervention.

Official Title
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The Safety and Tolerability of an Aerobic and Resistance Exercise Program With Cognitive Training Post-stroke

Conditions
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Cerebral Stroke

Intervention / Treatment
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* Behavioral: CARET
* Behavioral: CTI
* Behavioral: Sham CARET
* Behavioral: Sham CTI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of ischemic or hemorrhagic stroke Modified Rankin Score (mRS) of <4 at screening Recently discharged from the hospital or rehabilitation program Male or female ≥18 years of age Less than ideal physical activity ≥ 3 months prior to enrollment (less than ideal physical (as defined by the American Heart Association) Able to walk ≥10 meters with or without assistance Exclusion Criteria: Unable to follow instructions for exercise and cognitive interventions Any uncontrolled medical condition expected to limit life expectancy or interfere with participation in the trial (i.e. unstable cancer, severe depression or anxiety by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria) Abnormal stress test, as determined by the treating physician (unless cardiology clearance provided) Active substance abuse or alcohol dependence Less than 6th grade reading level Uncorrected vision or hearing deficits that would preclude administration of the cognitive measures Unwilling or unable to provide written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CARET + CTI<br>Combined Aerobic and Resistance Exercise Training (CARET) plus Cognitive Training Intervention (CTI) | Behavioral: CARET<br>* Combined Aerobic and Resistance Exercise Training<br>Behavioral: CTI<br>* Cognitive Training Intervention<br>|
| Sham Comparator: Sham CARET + Sham CTI<br>Control group Sham Combined Aerobic and Resistance Exercise Training (CARET) plus Sham Cognitive Training Intervention (CTI) | Behavioral: Sham CARET<br>* Sham Combined Aerobic and Resistance Exercise Training<br>Behavioral: Sham CTI<br>* Sham Cognitive Training Intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment emergent serious adverse events | To assess the number of participants with serious adverse events related to the interventions, comparing active groups versus the sham group. | At 12 weeks visit (post-intervention) | 
| Adherence to a 12-week combined exercise and cognitive training protocol versus a sham group | To assess participant adherence in the intervention group versus the sham group, comparing time on study. | At 12 weeks visit (post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cognitive Performance on cognitive neuropsychological battery done at pre, post and 6 month follow-up visits | Global cognitive performance will be compared for the intervention groups versus the sham group, using a cognitive assessment battery. | Baseline to 6 months follow up | 
| Change in Health Related Quality of Life - Depression | As measured by Center for Epidemiologic Studies Depression Scale (CES-D). Minimum score 0, maximum score 60, and a score of 16 or higher indicates clinical depression. | Baseline to 6 months follow up measure. | 
| Change in Health Related Quality of Life - Daily Activities | As measured by Stroke impact scale scores measuring health related quality of life. Minimum score 16, maximum score 80. Higher scores indicate higher level of functionality in participants, while lower scores indicate a lower level of functionality. | Baseline to 6 months follow up | 
| Change in blood plasma concentration of Brain Derived Neurotrophic Factor | Brain-derived neurotrophic factor (BDNF) levels will be compared between the exercise group and the sham group at baseline and 12 weeks. | Baseline to 6 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Exercise Training, Cognitive Training, Quality of Life