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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2019-03-20

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.

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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.

Conditions

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Cerebral Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CARET + CTI

Combined Aerobic and Resistance Exercise Training (CARET) plus Cognitive Training Intervention (CTI)

Group Type EXPERIMENTAL

CARET

Intervention Type BEHAVIORAL

Combined Aerobic and Resistance Exercise Training

CTI

Intervention Type BEHAVIORAL

Cognitive Training Intervention

Sham CARET + Sham CTI

Control group Sham Combined Aerobic and Resistance Exercise Training (CARET) plus Sham Cognitive Training Intervention (CTI)

Group Type SHAM_COMPARATOR

Sham CARET

Intervention Type BEHAVIORAL

Sham Combined Aerobic and Resistance Exercise Training

Sham CTI

Intervention Type BEHAVIORAL

Sham Cognitive Training Intervention

Interventions

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CARET

Combined Aerobic and Resistance Exercise Training

Intervention Type BEHAVIORAL

CTI

Cognitive Training Intervention

Intervention Type BEHAVIORAL

Sham CARET

Sham Combined Aerobic and Resistance Exercise Training

Intervention Type BEHAVIORAL

Sham CTI

Sham Cognitive Training Intervention

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No