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

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.

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