Forced Aerobic Exercise for Stroke

Overseen By Sara Davidson, PTA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Cardiac arrhythmia, Hypertrophic cardiomyopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 26

Duration: 8 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Susan Linder, DPT

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

This trial is for adults aged 18-85 who had a stroke at least 6 months ago, can walk over 20 meters with minimal help, and have moderate arm movement issues. It's not for those recently hospitalized for heart problems, arrhythmia, severe valve disease, lung clots or recent anti-spasticity treatments.

Inclusion Criteria

≥ 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

Exclusion Criteria

cardiac arrhythmia,

hypertrophic cardiomyopathy,

pulmonary embolus,

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo an exercise stress test and baseline clinical assessments to quantify upper extremity function, gait, endurance, and self-reported quality of life

1 week

1 visit (in-person)

Treatment

Participants receive either 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, 3 times per week for 8 weeks

8 weeks

24 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at mid-treatment, end of treatment, and at 4 weeks, 6-months, and 12-months following end of treatment

12 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Aerobic Exercise
• Upper Extremity Repetitive Task Practice

Trial Overview The study tests if forced aerobic exercise helps stroke survivors recover arm and leg function better than standard therapy. It also assesses the cost-effectiveness of these exercises compared to repetitive task practice for upper extremities.

Participant Groups

Group I: Upper Extremity Repetitive Task Practice Only Active Control 1 Intervention

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

Group II: Aerobic Exercise & Repetitive Task Practice Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+