Clinical trial NCT02272426: The Safety and Tolerability of an Aerobic and Resistance Exercise Program With Cognitive Training Post-stroke
Official title: The Safety and Tolerability of an Aerobic and Resistance Exercise Program With Cognitive Training Post-stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Stroke
Keywords: Stroke
Exercise Training
Cognitive Training
Quality of Life
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: Bugher Foundation
First posted: 2014-10-23
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with treatment emergent serious adverse events
timeFrame: At 12 weeks visit (post-intervention)
measure: Adherence to a 12-week combined exercise and cognitive training protocol versus a sham group
timeFrame: At 12 weeks visit (post-intervention)
Secondary outcomes:
measure: Change in Cognitive Performance on cognitive neuropsychological battery done at pre, post and 6 month follow-up visits
timeFrame: Baseline to 6 months follow up
measure: Change in Health Related Quality of Life - Depression
timeFrame: Baseline to 6 months follow up measure.
measure: Change in Health Related Quality of Life - Daily Activities
timeFrame: Baseline to 6 months follow up
measure: Change in blood plasma concentration of Brain Derived Neurotrophic Factor
timeFrame: Baseline to 6 month follow up
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Sebastian Koch, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koch S, Tiozzo E, Simonetto M, Loewenstein D, Wright CB, Dong C, Bustillo A, Perez-Pinzon M, Dave KR, Gutierrez CM, Lewis JE, Flothmann M, Mendoza-Puccini MC, Junco B, Rodriguez Z, Gomes-Osman J, Rundek T, Sacco RL. Randomized Trial of Combined Aerobic, Resistance, and Cognitive Training to Improve Recovery From Stroke: Feasibility and Safety. J Am Heart Assoc. 2020 May 18;9(10):e015377. doi: 10.1161/JAHA.119.015377. Epub 2020 May 12.