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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • CARET Behavioral
    Intervention Desc: Combined Aerobic and Resistance Exercise Training
    ARM 1: Kind: Experimental
    Label: CARET
    Description: Combined Aerobic and Resistance Exercise Training (CARET)
    ARM 2: Kind: Experimental
    Label: CARET + CTI
    Description: Combined Aerobic and Resistance Exercise Training (CARET) plus Cognitive Training Intervention (CTI)
  • CTI Behavioral
    Intervention Desc: Cognitive Training Intervention
    ARM 1: Kind: Experimental
    Label: CARET + CTI
    Description: Combined Aerobic and Resistance Exercise Training (CARET) plus Cognitive Training Intervention (CTI)
  • Sham CARET Behavioral
    Intervention Desc: Sham Combined Aerobic and Resistance Exercise Training
    ARM 1: Kind: Experimental
    Label: Sham CARET + Sham CTI
    Description: Control group Sham Combined Aerobic and Resistance Exercise Training (CARET) plus Sham Cognitive Training Intervention (CTI)
  • Sham CTI Behavioral
    Intervention Desc: Sham Cognitive Training Intervention
    ARM 1: Kind: Experimental
    Label: Sham CARET + Sham CTI
    Description: Control group Sham Combined Aerobic and Resistance Exercise Training (CARET) plus Sham Cognitive Training Intervention (CTI)

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Supportive Care
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Safety At 12 weeks visit (post-intervention) Yes
Primary Adherence At 12 weeks visit (post-intervention) No
Secondary Cognitive Performance Baseline to 6 months follow up No
Secondary Health Related Quality of Life Baseline to 6 months follow up No
Secondary Brain Derived Neurotrophic Factor Baseline to 6 month follow up No

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