Clinical trial NCT03819764: Cost-effectiveness of Forced Aerobic Exercise for Stroke Rehabilitation
Official title: Cost-effectiveness and Efficacy of a Combined Intervention to Facilitate Motor Recovery Following Stroke
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Keywords: stroke
aerobic exercise
forced exercise
repetitive task practice
arm function
upper extremity
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: Baseline
measure: Fugl-Meyer Assessment (FMA)
timeFrame: midpoint (4 weeks from Baseline)
measure: Fugl-Meyer Assessment (FMA)
timeFrame: end of treatment (8 weeks from Baseline)
measure: Fugl-Meyer Assessment (FMA)
timeFrame: end of treatment +4 weeks (12 weeks from Baseline)
measure: Fugl-Meyer Assessment (FMA)
timeFrame: end of treatment +6 months (8 months from Baseline)
measure: Fugl-Meyer Assessment (FMA)
timeFrame: end of treatment +1 year (14 months from Baseline)
measure: Action Research Arm Test (ARAT)
timeFrame: Baseline
measure: Action Research Arm Test (ARAT)
timeFrame: end of treatment (8 weeks from Baseline)
measure: Action Research Arm Test (ARAT)
timeFrame: end of treatment +4 weeks (12 weeks from Baseline)
measure: Action Research Arm Test (ARAT)
timeFrame: end of treatment +6 months (8 months from Baseline)
measure: Action Research Arm Test (ARAT)
timeFrame: end of treatment +1 year (14 months from Baseline)
Secondary outcomes:
measure: Wolf Motor Function Test (WMFT)
timeFrame: Baseline
measure: Wolf Motor Function Test (WMFT)
timeFrame: end of treatment (8 weeks from Baseline)
measure: Stroke Impact Scale (SIS)
timeFrame: Baseline
measure: Stroke Impact Scale (SIS)
timeFrame: end of treatment (8 weeks from Baseline)
measure: Stroke Impact Scale (SIS)
timeFrame: end of treatment +6 months (8 months from Baseline)
measure: Stroke Impact Scale (SIS)
timeFrame: end of treatment +1 year (14 months from Baseline)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: Baseline
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: end of treatment (8 weeks from Baseline)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: end of treatment +6 months (8 months from Baseline)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: end of treatment +1 year (14 months from Baseline)
measure: Center for Epidemiological Studies-Depression (CES-D)
timeFrame: Baseline
measure: Center for Epidemiological Studies-Depression (CES-D)
timeFrame: end of treatment (8 weeks from Baseline)
measure: Center for Epidemiological Studies-Depression (CES-D)
timeFrame: end of treatment +6 months (8 months from Baseline)
measure: Center for Epidemiological Studies-Depression (CES-D)
timeFrame: end of treatment +1 year (14 months from Baseline)
measure: Six-Minute Walk Test (6MWT)
timeFrame: Baseline
measure: Six-Minute Walk Test (6MWT)
timeFrame: end of treatment (8 weeks)
measure: Six-Minute Walk Test (6MWT)
timeFrame: end of treatment +4 weeks (12 weeks from Baseline)
measure: Six-Minute Walk Test (6MWT)
timeFrame: end of treatment +6 months (8 months from Baseline)
measure: Six-Minute Walk Test (6MWT)
timeFrame: end of treatment +1 year (14 months from Baseline)
measure: Modified Rankin Scale
timeFrame: Baseline
measure: Modified Rankin Scale
timeFrame: end of treatment (8 weeks from Baseline)
measure: Modified Rankin Scale
timeFrame: end of treatment +6 months (8 months from Baseline)
measure: Modified Rankin Scale
timeFrame: end of treatment +1 year (14 months from Baseline)
measure: Right Step Length
timeFrame: Baseline
measure: Right Step Length
timeFrame: end of treatment (8 weeks from Baseline)
measure: Left Step Length
timeFrame: Baseline
measure: Left Step Length
timeFrame: end of treatment (8 weeks from Baseline)
measure: Right Step Width
timeFrame: Baseline
measure: Right Step Width
timeFrame: end of treatment (8 weeks from Baseline)
measure: Left Step Width
timeFrame: Baseline
measure: Left Step Width
timeFrame: end of treatment (8 weeks from Baseline)
measure: Right Stance Time
timeFrame: Baseline
measure: Right Stance Time
timeFrame: end of treatment (8 weeks from Baseline)
measure: Left Stance Time
timeFrame: Baseline
measure: Left Stance Time
timeFrame: end of treatment (8 weeks from Baseline)
measure: Right Swing Time
timeFrame: Baseline
measure: Right Swing Time
timeFrame: end of treatment (8 weeks from Baseline)
measure: Left Swing Time
timeFrame: Baseline
measure: Left Swing Time
timeFrame: end of treatment (8 weeks from Baseline)
measure: Walking Speed
timeFrame: Baseline
measure: Walking Speed
timeFrame: end of treatment (8 weeks from Baseline)
measure: Walking Cadence
timeFrame: Baseline
measure: Walking Cadence
timeFrame: end of treatment (8 weeks from Baseline)
measure: Left Knee Range of Motion
timeFrame: Baseline
measure: Left Knee Range of Motion
timeFrame: end of treatment (8 weeks from Baseline)
measure: Right Knee Range of Motion
timeFrame: Baseline
measure: Right Knee Range of Motion
timeFrame: end of treatment (8 weeks from Baseline)
measure: Left Ankle Range of Motion
timeFrame: Baseline
measure: Left Ankle Range of Motion
timeFrame: end of treatment (8 weeks from Baseline)
measure: Right Ankle Range of Motion
timeFrame: Baseline
measure: Right Ankle Range of Motion
timeFrame: end of treatment (8 weeks from Baseline)
measure: Left Hip Range of Motion (sagittal plane)
timeFrame: Baseline
measure: Left Hip Range of Motion (sagittal plane)
timeFrame: end of treatment (8 weeks from Baseline)
measure: Right Hip Range of Motion (sagittal plane)
timeFrame: Baseline
measure: Right Hip Range of Motion (sagittal plane)
timeFrame: end of treatment (8 weeks from Baseline)
measure: Left Hip Range of Motion (coronal plane)
timeFrame: Baseline
measure: Left Hip Range of Motion (coronal plane)
timeFrame: end of treatment (8 weeks from Baseline)
measure: Right Hip Range of Motion (coronal plane)
timeFrame: Baseline
measure: Right Hip Range of Motion (coronal plane)
timeFrame: end of treatment (8 weeks from Baseline)
measure: Left Hip Range of Motion (transverse plane)
timeFrame: Baseline
measure: Left Hip Range of Motion (transverse plane)
timeFrame: end of treatment (8 weeks from Baseline)
measure: Right Hip Range of Motion (transverse plane)
timeFrame: Baseline
measure: Right Hip Range of Motion (transverse plane)
timeFrame: end of treatment (8 weeks from Baseline)
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Susan Linder, DPT
role: PRINCIPAL_INVESTIGATOR
References: