Cost-effectiveness of Forced Aerobic Exercise for Stroke Rehabilitation

  • STATUS
    Recruiting
  • End date
    Aug 24, 2023
  • participants needed
    60
  • sponsor
    The Cleveland Clinic
Updated on 24 January 2021
stroke
rehabilitation therapy
hemorrhagic stroke
stroke rehabilitation

Summary

The purpose of this study is to investigate whether aerobic exercise improves the participant's ability to recover function in the arm and leg affected by the participant's stroke. The investigators are also calculating the cost effectiveness of the rehabilitation interventions.

Description

The aims of the study are to determine the clinical efficacy and cost-effectiveness of combining aerobic exercise training with upper extremity motor task practice to improve motor recovery following stroke. It is hypothesized that the neurophysiologic impact of aerobic exercise may augment motor recovery associated with motor task practice. To test this hypothesize, 60 individuals with chronic stroke will be recruited to participate in this randomized clinical trial. Following screening and informed consent, all participants will undergo an exercise stress test to determine response to maximal exertion. Following the stress test, baseline clinical assessments will be obtained to quantify upper extremity function, gait, endurance, and self-reported quality of life. Additionally, variables to determine degree of disability will be obtained. Individuals will be randomized to one of two interventions: 45 min of forced-rate aerobic exercise paired with 45 min of upper limb repetitive task practice or two back-to-back 45-minute sessions of upper limb repetitive task practice. The interventions will occur 3 times per week for 8 weeks. Outcomes assessing motor function and disability will be repeated at mid-treatment, end of treatment, and at 4 weeks, 6-months and 12-months following end of treatment.

Details
Condition Brain Diseases, CNS disorder, Vascular Diseases, Cerebrovascular accident, nervous system disorder, Cardiovascular Disease, Cerebrovascular disease, Stroke, Neurologic Disorders, vascular disorder, cerebrovascular diseases, neurological disorders, neurological disorder, neurologic disorder, disorders of the nervous system, nervous system disease, neurological disease, nervous system disorders, cardiovascular diseases, cardiovascular disease (cvd), cardiovascular system diseases, cardiovascular disorders, vascular disease, vasculopathy, vasc, cns disease, diseases of the central nervous system, central nervous system disorders, central nervous system disease, disorder central nervous system, brain disorders, brain disorder, brain disease, cerebrovascular accidents, strokes, cerebral
Treatment Aerobic Exercise, Upper Extremity Repetitive Task Practice
Clinical Study IdentifierNCT03819764
SponsorThe Cleveland Clinic
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 85 yrs?
Gender: Male or Female
Do you have any of these conditions: Cerebrovascular accident or Vascular Diseases or Cerebrovascular disease or Brain Diseases or Stroke or CNS disorder or Cardiovascular Disease or Neur...?
Do you have any of these conditions: brain disease or cardiovascular diseases or brain disorder or neurological disorders or brain disorders or vasculopathy or Cerebrovascular disease or ...?
6 months following single ischemic or hemorrhagic stroke confirmed with neuroimaging
Fugl-Meyer motor score 19-55 in the involved upper extremity
Ambulatory 20 meters with no more than contact guard assistance, and
18-85 years of age

Exclusion Criteria

hospitalization for myocardial infarction, heart failure or heart surgery within 3 months
cardiac arrhythmia
hypertrophic cardiomyopathy
severe aortic stenosis
pulmonary embolus
significant contractures
anti-spasticity injection within 3 months of enrollment and
other contraindication to exercise
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