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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272426
Recruitment Status : Active, not recruiting
First Posted : October 23, 2014
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
American Heart Association
Bugher Foundation
Information provided by (Responsible Party):
Sebastian Koch, University of Miami

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.

Condition or disease Intervention/treatment Phase
Cerebral Stroke Behavioral: CARET Behavioral: CTI Behavioral: Sham CARET Behavioral: Sham CTI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Safety and Tolerability of an Aerobic and Resistance Exercise Program With Cognitive Training Post-stroke
Study Start Date : November 2014
Actual Primary Completion Date : March 20, 2019
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CARET + CTI
Combined Aerobic and Resistance Exercise Training (CARET) plus Cognitive Training Intervention (CTI)
Behavioral: CARET
Combined Aerobic and Resistance Exercise Training

Behavioral: CTI
Cognitive Training Intervention

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

Behavioral: Sham CTI
Sham Cognitive Training Intervention




Primary Outcome Measures :
  1. Number of participants with treatment emergent serious adverse events [ Time Frame: At 12 weeks visit (post-intervention) ]
    To assess the number of participants with serious adverse events related to the interventions, comparing active groups versus the sham group.

  2. Adherence to a 12-week combined exercise and cognitive training protocol versus a sham group [ Time Frame: At 12 weeks visit (post-intervention) ]
    To assess participant adherence in the intervention group versus the sham group, comparing time on study.


Secondary Outcome Measures :
  1. Change in Cognitive Performance on cognitive neuropsychological battery done at pre, post and 6 month follow-up visits [ Time Frame: Baseline to 6 months follow up ]
    Global cognitive performance will be compared for the intervention groups versus the sham group, using a cognitive assessment battery.

  2. Change in Health Related Quality of Life - Depression [ Time Frame: Baseline to 6 months follow up measure. ]
    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.

  3. Change in Health Related Quality of Life - Daily Activities [ Time Frame: Baseline to 6 months follow up ]
    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.

  4. Change in blood plasma concentration of Brain Derived Neurotrophic Factor [ Time Frame: Baseline to 6 month follow up ]
    Brain-derived neurotrophic factor (BDNF) levels will be compared between the exercise group and the sham group at baseline and 12 weeks.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272426


Locations
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United States, Florida
Jackson Memorial Hospital
Miami, Florida, United States, 33136
University of Miami Hospital
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
American Heart Association
Bugher Foundation
Investigators
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Principal Investigator: Sebastian Koch, M.D. University of Miami

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Responsible Party: Sebastian Koch, Professor of Neurology, University of Miami
ClinicalTrials.gov Identifier: NCT02272426    
Other Study ID Numbers: 20140203
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Keywords provided by Sebastian Koch, University of Miami:
Stroke
Exercise Training
Cognitive Training
Quality of Life
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases