The Safety and Tolerability of an Aerobic and Resistance Exercise Program With Cognitive Training Post-stroke
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|ClinicalTrials.gov Identifier: NCT02272426|
Recruitment Status : Active, not recruiting
First Posted : October 23, 2014
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Stroke||Behavioral: CARET Behavioral: CTI Behavioral: Sham CARET Behavioral: Sham CTI||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||132 participants|
|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|
Experimental: CARET + CTI
Combined Aerobic and Resistance Exercise Training (CARET) plus Cognitive Training Intervention (CTI)
Combined Aerobic and Resistance Exercise Training
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|United States, Florida|
|Jackson Memorial Hospital|
|Miami, Florida, United States, 33136|
|University of Miami Hospital|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Sebastian Koch, M.D.||University of Miami|