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| Name | Class |
|---|---|
| American Heart Association | OTHER |
| Bugher Foundation | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CARET + CTI | Experimental | Combined Aerobic and Resistance Exercise Training (CARET) plus Cognitive Training Intervention (CTI) |
|
| Sham CARET + Sham CTI | Sham Comparator | Control group Sham Combined Aerobic and Resistance Exercise Training (CARET) plus Sham Cognitive Training Intervention (CTI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CARET | Behavioral | Combined Aerobic and Resistance Exercise Training |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment emergent serious adverse events | To assess the number of participants with serious adverse events related to the interventions, comparing active groups versus the sham group. | At 12 weeks visit (post-intervention) |
| Adherence to a 12-week combined exercise and cognitive training protocol versus a sham group | To assess participant adherence in the intervention group versus the sham group, comparing time on study. | At 12 weeks visit (post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cognitive Performance on cognitive neuropsychological battery done at pre, post and 6 month follow-up visits | Global cognitive performance will be compared for the intervention groups versus the sham group, using a cognitive assessment battery. | Baseline to 6 months follow up |
| Change in Health Related Quality of Life - Depression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastian Koch, M.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jackson Memorial Hospital | Miami | Florida | 33136 | United States | ||
| University of Miami Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32394777 | Derived | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| CTI |
| Behavioral |
Cognitive Training Intervention |
|
| Sham CARET | Behavioral | Sham Combined Aerobic and Resistance Exercise Training |
|
| Sham CTI | Behavioral | Sham Cognitive Training Intervention |
|
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. |
| Baseline to 6 months follow up measure. |
| Change in Health Related Quality of Life - Daily Activities | 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. | Baseline to 6 months follow up |
| Change in blood plasma concentration of Brain Derived Neurotrophic Factor | Brain-derived neurotrophic factor (BDNF) levels will be compared between the exercise group and the sham group at baseline and 12 weeks. | Baseline to 6 month follow up |
| Miami |
| Florida |
| 33136 |
| United States |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |