The Safety and Tolerability of an Aerobic and Resistance Exercise Program With Cognitive Training Post-stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Number of participants with treatment emergent serious adverse events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
CARET + CTI
Combined Aerobic and Resistance Exercise Training (CARET) plus Cognitive Training Intervention (CTI)
干预措施: CARET (Behavioral)
CARET + CTI
Combined Aerobic and Resistance Exercise Training (CARET) plus Cognitive Training Intervention (CTI)
干预措施: CTI (Behavioral)
Sham CARET + Sham CTI
Control group Sham Combined Aerobic and Resistance Exercise Training (CARET) plus Sham Cognitive Training Intervention (CTI)
干预措施: Sham CARET (Behavioral)
Sham CARET + Sham CTI
Control group Sham Combined Aerobic and Resistance Exercise Training (CARET) plus Sham Cognitive Training Intervention (CTI)
干预措施: Sham CTI (Behavioral)
结局指标
主要结局
Number of participants with treatment emergent serious adverse events
时间窗: 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
时间窗: At 12 weeks visit (post-intervention)
To assess participant adherence in the intervention group versus the sham group, comparing time on study.
次要结局
- Change in Cognitive Performance on cognitive neuropsychological battery done at pre, post and 6 month follow-up visits(Baseline to 6 months follow up)
- Change in Health Related Quality of Life - Depression(Baseline to 6 months follow up measure.)
- Change in Health Related Quality of Life - Daily Activities(Baseline to 6 months follow up)
- Change in blood plasma concentration of Brain Derived Neurotrophic Factor(Baseline to 6 month follow up)
研究者
Sebastian Koch
Professor of Neurology
University of Miami