N/A
Completed N=60
Cost-effectiveness of Forced Aerobic Exercise for Stroke Rehabilitation
Stroke · Cerebrovascular Disorders · Brain Diseases · Central Nervous System Diseases
Source: ClinicalTrials.gov NCT03819764 ↗
Enrolled (actual)
60
Serious AEs
6.7%
Results posted
Jul 2025
Primary outcomePrimary: Fugl-Meyer Assessment (FMA) — 32.5; 32.8 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fugl-Meyer Assessment (FMA) |
44.8; 46.8 | — |
| PRIMARY Fugl-Meyer Assessment (FMA) |
44.8; 46.8 | — |
| PRIMARY Fugl-Meyer Assessment (FMA) |
44.8; 46.8 | — |
| PRIMARY Fugl-Meyer Assessment (FMA) |
44.8; 46.8 | — |
| PRIMARY Fugl-Meyer Assessment (FMA) |
44.8; 46.8 | — |
| PRIMARY Fugl-Meyer Assessment (FMA) |
44.8; 46.8 | — |
| PRIMARY Action Research Arm Test (ARAT) |
38.5; 40.9; 14.2; 14.1; 7.1; 8.0 | — |
| PRIMARY Action Research Arm Test (ARAT) |
38.5; 40.9; 14.2; 14.1; 7.1; 8.0 | — |
| PRIMARY Action Research Arm Test (ARAT) |
38.5; 40.9; 14.2; 14.1; 7.1; 8.0 | — |
| PRIMARY Action Research Arm Test (ARAT) |
38.5; 40.9; 14.2; 14.1; 7.1; 8.0 | — |
| PRIMARY Action Research Arm Test (ARAT) |
38.5; 40.9; 14.2; 14.1; 7.1; 8.0 | — |
| SECONDARY Wolf Motor Function Test (WMFT) |
8.2; 10.0 | — |
| SECONDARY Stroke Impact Scale (SIS) |
60.1; 59.4; 88.1; 90.9; 82.5; 81.5 | — |
| SECONDARY Stroke Impact Scale (SIS) |
60.1; 59.4; 88.1; 90.9; 82.5; 81.5 | — |
| SECONDARY Stroke Impact Scale (SIS) |
60.1; 59.4; 88.1; 90.9; 82.5; 81.5 | — |
| SECONDARY Stroke Impact Scale (SIS) |
60.1; 59.4; 88.1; 90.9; 82.5; 81.5 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS-29) |
41.1; 40.5; 47.9; 49.1; 48.2; 48.1 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS-29) |
41.1; 40.5; 47.9; 49.1; 48.2; 48.1 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS-29) |
41.1; 40.5; 47.9; 49.1; 48.2; 48.1 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS-29) |
41.1; 40.5; 47.9; 49.1; 48.2; 48.1 | — |
| SECONDARY Center for Epidemiological Studies-Depression (CES-D) |
9.3; 9.7 | — |
| SECONDARY Center for Epidemiological Studies-Depression (CES-D) |
9.3; 9.7 | — |
| SECONDARY Center for Epidemiological Studies-Depression (CES-D) |
9.3; 9.7 | — |
| SECONDARY Center for Epidemiological Studies-Depression (CES-D) |
9.3; 9.7 | — |
| SECONDARY Six-Minute Walk Test (6MWT) |
320.8; 336.7 | — |
| SECONDARY Six-Minute Walk Test (6MWT) |
320.8; 336.7 | — |
| SECONDARY Six-Minute Walk Test (6MWT) |
320.8; 336.7 | — |
| SECONDARY Six-Minute Walk Test (6MWT) |
320.8; 336.7 | — |
| SECONDARY Six-Minute Walk Test (6MWT) |
320.8; 336.7 | — |
| SECONDARY Paretic Step Length |
45.0; 46.9 | — |
| SECONDARY Non-Paretic Step Length |
45.0; 46.1 | — |
| SECONDARY Paretic Step Length |
45.0; 46.9 | — |
| SECONDARY Non-Paretic Step Length |
45.0; 46.1 | — |
| SECONDARY Non-Paretic Single Limb Percentage |
29.8; 30.5 | — |
| SECONDARY Non-Paretic Single Limb Percentage |
29.8; 30.5 | — |
| SECONDARY Modified Rankin Scale |
2; 2 | — |
| SECONDARY Modified Rankin Scale |
2; 2 | — |
| SECONDARY Walking Cadence |
86.1; 85.8 | — |
| SECONDARY Walking Cadence |
86.1; 85.8 | — |
| SECONDARY Paretic Single Limb Percentage |
27.9; 28.9 | — |
| SECONDARY Paretic Single Limb Percentage |
27.9; 28.9 | — |
| SECONDARY Paretic Knee Range of Motion |
44.0; 53.4 | — |
| SECONDARY Paretic Knee Range of Motion |
44.0; 53.4 | — |
| SECONDARY Non-Paretic Knee Range of Motion |
54.8; 62.4 | — |
| SECONDARY Non-Paretic Knee Range of Motion |
54.8; 62.4 | — |
| SECONDARY Paretic Ankle Range of Motion |
19.1; 19.1 | — |
| SECONDARY Paretic Ankle Range of Motion |
19.1; 19.1 | — |
| SECONDARY Non-Paretic Ankle Range of Motion |
24.8; 23.2 | — |
| SECONDARY Non-Paretic Ankle Range of Motion |
24.8; 23.2 | — |
| SECONDARY Paretic Hip Range of Motion (Sagittal Plane) |
35.6; 39.5 | — |
| SECONDARY Paretic Hip Range of Motion (Sagittal Plane) |
35.6; 39.5 | — |
| SECONDARY Non-Paretic Hip Range of Motion (Sagittal Plane) |
39.9; 43.0 | — |
| SECONDARY Non-Paretic Hip Range of Motion (Sagittal Plane) |
39.9; 43.0 | — |
| SECONDARY Wolf Motor Function Test (WMFT) Functional Ability Score |
2.4; 2.7 | — |
| SECONDARY Wolf Motor Function Test (WMFT) Grip Strength |
13.8; 13.8 | — |
| SECONDARY Wolf Motor Function Test (WMFT) Weight to Box |
8.2; 8.7 | — |
| SECONDARY Wolf Motor Function Test (WMFT) |
8.2; 10.0 | — |
| SECONDARY Wolf Motor Function Test (WMFT) Functional Ability Score |
2.4; 2.7 | — |
| SECONDARY Wolf Motor Function Test (WMFT) Grip Strength |
13.8; 13.8 | — |
| SECONDARY Wolf Motor Function Test (WMFT) Weight to Box |
8.2; 8.7 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity |
2.7; 2.7 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity |
2.7; 2.7 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity |
2.7; 2.7 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity |
2.7; 2.7 | — |
Eligibility Criteria
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
- 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
Data sourced from ClinicalTrials.gov (NCT03819764). 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.