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

Completed · Not applicable · Has a placebo group

Conditions studied: Cerebral Stroke

In brief

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.

Key facts

Study ID

NCT02272426

Run by

University of Miami

People needed

132

Starts

2014-11-01

Expected to finish

2019-03-20

Last updated by the study team

2020-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Jackson Memorial Hospital — Miami, Florida, United States
• University of Miami Hospital — Miami, Florida, United States

Full record on ClinicalTrials.gov

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