Cost-effectiveness of Forced Aerobic Exercise for Stroke Rehabilitation

NeuroTherapia, Inc.

Status: Completed

Conditions: Stroke; Central Nervous System Diseases; Cardiovascular Diseases; Nervous System Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases

Treatments: Behavioral: Aerobic Exercise; Behavioral: Upper Extremity Repetitive Task Practice

Study type: Interventional

Funder types: Other

Identifiers

NCT03819764

18-734

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥ 6 months following single ischemic or hemorrhagic stroke confirmed with neuroimaging,
2. Fugl-Meyer motor score 19-55 in the involved upper extremity,
3. Ambulatory ≥ 20 meters with no more than contact guard assistance, and
4. 18-85 years of age.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Aerobic Exercise & Repetitive Task Practice

Active Comparator group

Description:

Participants will perform the following: 1. 45 minutes of cycling 2. 45 minutes of upper extremity repetitive arm exercises

Treatment:

Behavioral: Upper Extremity Repetitive Task Practice

Behavioral: Aerobic Exercise

Upper Extremity Repetitive Task Practice Only

Active Comparator group

Description:

Participants will perform the following: 1. 90 minutes of upper extremity repetitive arm exercises

Treatment:

Behavioral: Upper Extremity Repetitive Task Practice