N/A
Completed N=34
Forced Aerobic Exercise for Stroke Rehabilitation
Source: ClinicalTrials.gov NCT02494518 ↗Enrolled (actual)
34
Serious AEs
2.9%
Results posted
Mar 2019
Primary outcomePrimary: Fugl Meyer Assessment — 6.90; 4.00; 6.25; 10.10 units on a scale
Summary
The purpose of the study is to determine if performing different types of aerobic exercise (cycling) before upper extremity exercises will help to improve outcomes after stroke.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fugl Meyer Assessment |
6.90; 4.00; 6.25; 10.10; 6.50; 8.88 | — |
| PRIMARY Wolf Motor Function Test |
7.80; 6.40; 10.50; 9.22; 9.60; 10.88 | — |
| PRIMARY Stroke Impact Scale |
15.00; 14.50; 9.38; 19.44; 14.00; 21.25 | — |
| PRIMARY Metabolic Stress Test |
0.02; 1.09; 0.40 | — |
| SECONDARY Action Research Arm Test |
8.60; 6.30; 6.38; 8.56; 7.50; 7.13 | — |
| SECONDARY Center for Epidemiological Studies-Depression |
-5.20; -0.30; -2.00; -3.67; -2.60; -3.75 | — |
| SECONDARY Processing Speed Test |
0.90; 1.88; 2.71; 2.89; 3.25; 6.38 | — |
| SECONDARY Nine Hole Peg Test |
-8.07; -16.15; -19.35; -8.10; -7.81; -29.15 | — |
| SECONDARY Six Minute Walk Test |
133.20; 188.70; -21.75; 78.50; 127.70; 78.88 | — |
Eligibility Criteria
Inclusion Criteria
- Able to provide informed consent
- At least 6 months post diagnosis of single ischemic stroke, confirmed with neuroimaging
- Fugl-Meyer Motor Score 19-55 in involved upper extremity
- Approval from patient's physician
- Age between 18 and 85 years
Exclusion Criteria
- Hospitalization for myocardial infarction, congestive heart failure, or heart surgery (CABG or valve replacement) within 3 months of study enrollment
- Serious cardiac arrhythmia
- Other serious heart and lung conditions (i.e.cardiomyopathy, aortic stenosis, cardiac pacemaker, pulmonary embolus)
- Other medical or musculoskeletal contraindication to exercise
- Significant cognitive impairment (unable to follow 1-2 step commands) or major psychiatric disorder (major depression, generalized anxiety) that will cause difficulty in study participation
- Anti-spasticity injection (botox) in upper extremity within 3 months of study enrollment
- Pregnancy
- Unstable blood pressure at rest or with exercise
Data sourced from ClinicalTrials.gov (NCT02494518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.