NCT03819764

Cost-effectiveness of Forced Aerobic Exercise for Stroke Rehabilitation

Cost-effectiveness and Efficacy of a Combined Intervention to Facilitate Motor Recovery Following Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Stroke
• Cerebrovascular Disorders
• Brain Diseases
• Central Nervous System Diseases
• Nervous System Diseases
• Vascular Diseases
• Cardiovascular Diseases

Interventions

Type	Name	Description
BEHAVIORAL	Aerobic Exercise	Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed
BEHAVIORAL	Upper Extremity Repetitive Task Practice	Repetitive arm exercises

Timeline

• Start date: 2019-04-11
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2019-01-29
• Last updated: 2025-07-29
• Results posted: 2025-07-29

Locations

1 site across 1 country: United States