Cost-effectiveness of Forced Aerobic Exercise for Stroke Rehabilitation

Not Applicable

Completed

Conditions: Cardiovascular Diseases
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Nervous System Diseases

Registration Number: NCT03819764

Lead Sponsor: The Cleveland Clinic

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment (FMA)	end of treatment +1 year (14 months from Baseline)	The Fugl-Meyer Assessment is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
Action Research Arm Test (ARAT)	end of treatment +1 year (14 months from Baseline)	The Action Research Arm Test is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome. The test includes 4 subscales: grasp (6 items, score range 0-18), grip (4 items, score range 0-12), pinch (6 items, score range 0-18), and gross motor (3 items, score range 0-9 ) which are added up for the total score. For all subscales, higher scores indicate better function.

Secondary Outcome Measures

Name	Time	Method
Wolf Motor Function Test (WMFT)	end of treatment (8 weeks from baseline)	The Wolf Motor Function Test includes 15 timed tasks for the affected upper extremity. Times for timed tasks are transformed and reported as geometric mean (standard deviation). Lower times indicate better performance.
Stroke Impact Scale (SIS)	end of treatment +1 year (14 months from Baseline)	The Stroke Impact Scale is a self-reported questionnaire evaluating quality of life. 8 domains are assessed including: physical problems, memory and thinking, feelings, communication, activities of daily living (ADLs), mobility, hand use, and meaningful activities. Scores for all domains are normalized and range from 0-100, with higher scores indicating a better self-perceived quality of life. The last domain (stroke recovery) asks the individual to rate their recovery on a scale of 0-100, with 0 indicating no recovery and 100 indicating full recovery.
Patient-Reported Outcomes Measurement Information System (PROMIS-29)	end of treatment +1 year (14 months from Baseline)	The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a self-reported questionnaire evaluating physical, mental, and social health. T-scores are reported separately for Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Physical Function, and Pain Interference. * A score of 50 represents the population mean. * A score of 40 is one standard deviation lower than the mean of the reference population. * A score of 60 is one standard deviation higher than the mean of the reference population. * For PROMIS measures, higher scores for domains measuring symptoms is indicative of greater symptom burden. Therefore, higher scores are worse for fatigue, anxiety, depression, sleep disturbance, and pain interference. For the domains of Physical Function and Participation, higher scores indicate better function and better participation, respectively.
Center for Epidemiological Studies-Depression (CES-D)	end of treatment +1 year (14 months from Baseline)	The Center for Epidemiological Studies-Depression (CES-D) is a 20 item assessment of depressive symptomology. Total score is reported, scores range from 0-60, with higher scores indicating higher risk of depression. A score of 16 or more is indicative of depression.
Six-Minute Walk Test (6MWT)	end of treatment +1 year (14 months from Baseline)	The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.
Paretic Step Length	end of treatment (8 weeks from Baseline)	Mean Paretic step length (cm) across two 2-minute walking trials
Non-Paretic Step Length	end of treatment (8 weeks from Baseline)	Mean Non-Paretic step length (cm) across two 2-minute walking trials
Non-Paretic Single Limb Percentage	end of treatment (8 weeks from Baseline)	Mean percentage of gait cycle spent in stance phase on the Non-Paretic lower extremity across two 2-minute walking trials
Modified Rankin Scale	end of treatment (8 weeks from Baseline)	The modified Rankin Scale is a global outcome on a scale of 0-6 used to assess the degree of disability in patients with stroke as follows: 0 No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
Walking Cadence	end of treatment (8 weeks from Baseline)	Steps walked per minute during two 2-minute walking trials
Paretic Single Limb Percentage	end of treatment (8 weeks from Baseline)	Percentage of gait cycle spent in single limb support
Paretic Knee Range of Motion	end of treatment (8 weeks from Baseline)	Mean peak degree of paretic knee flexion across two 2-minute walking trials
Non-Paretic Knee Range of Motion	end of treatment (8 weeks from Baseline)	Mean peak degree of non-paretic knee flexion across two 2-minute walking trials
Paretic Ankle Range of Motion	end of treatment (8 weeks from Baseline)	Mean peak degree of paretic ankle dorsiflexion across two 2-minute walking trials
Non-Paretic Ankle Range of Motion	end of treatment (8 weeks from Baseline)	Mean peak degree of non-paretic ankle dorsiflexion across two 2-minute walking trials
Paretic Hip Range of Motion (Sagittal Plane)	end of treatment (8 weeks from Baseline)	Mean peak degree of paretic hip flexion across two 2-minute walking trials
Non-Paretic Hip Range of Motion (Sagittal Plane)	end of treatment (8 weeks from Baseline)	Mean peak degree of non-paretic hip flexion across two 2-minute walking trials
Wolf Motor Function Test (WMFT) Functional Ability Score	Baseline	The WMFT Functional Ability Score quantifies movement quality. Scores range from 0-75, with higher scores indicating a better outcome.
Wolf Motor Function Test (WMFT) Grip Strength	baseline	The Wolf Motor Function Test includes Grip strength measured by dynamometer
Wolf Motor Function Test (WMFT) Weight to Box	baseline	The Wolf Motor Function Test includes the amount of weight the individual can lift onto a box using a wrist cuff weight ranging from 1-20 pounds. Higher indicates greater strength.
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity	end of treatment + 12 months (14 months from baseline)	The Patient-Reported Outcomes Measurement Information System includes pain rated on a 0-10 scale with higher scores indicative of greater pain.