Cost-effectiveness of Forced Aerobic Exercise for Stroke Rehabilitation

Not Applicable

Active, not recruiting

• Conditions: Cardiovascular Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Nervous System Diseases
• Interventions: Behavioral: Upper Extremity Repetitive Task Practice; Behavioral: Aerobic Exercise

• 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.

Study Timeline

• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-29
• Study Start: 2019-04-11
• Primary Completion: 2024-01-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Upper Extremity Repetitive Task Practice Only	Upper Extremity Repetitive Task Practice	Participants will perform the following: 1. 90 minutes of upper extremity repetitive arm exercises
Aerobic Exercise & Repetitive Task Practice	Aerobic Exercise	Participants will perform the following: 1. 45 minutes of cycling 2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise & Repetitive Task Practice	Upper Extremity Repetitive Task Practice	Participants will perform the following: 1. 45 minutes of cycling 2. 45 minutes of upper extremity repetitive arm exercises

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment (FMA)	end of treatment +1 year (14 months from Baseline)	This 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)	This 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.

Secondary Outcome Measures

Name	Time	Method
Left Knee Range of Motion	end of treatment (8 weeks from Baseline)	Mean peak degree of left knee flexion across two 2-minute walking trials
Right Knee Range of Motion	end of treatment (8 weeks from Baseline)	Mean peak degree of right knee flexion across two 2-minute walking trials
Wolf Motor Function Test (WMFT)	end of treatment (8 weeks from Baseline)	This consists of 2 strength tasks and 15 timed tasks of both the affected upper extremity and the unaffected upper extremity. Total Functional Ability Score is reported, scores range from 0-75, with higher scores indicating a better outcome.
Center for Epidemiological Studies-Depression (CES-D)	end of treatment +1 year (14 months from Baseline)	This 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.
Modified Rankin Scale	end of treatment +1 year (14 months from Baseline)	0-6 scale to determine degree of disability in individuals with a disabling condition. A score of 0 indicates no symptoms, 1 indicates no significant disability despite symptoms, 2 indicates slight disability, 3 indicates moderate disability, 4 indicates moderately severe level of disability, 5 indicates severe disability, and 6 indicates death.
Patient-Reported Outcomes Measurement Information System (PROMIS-29)	end of treatment +1 year (14 months from Baseline)	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 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 equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.
Stroke Impact Scale (SIS)	end of treatment +1 year (14 months from Baseline)	This is a self-reported questionnaire evaluating quality of life. Normalized Hand Function is reported, scores range from 0-100, with higher scores indicating a better outcome.
Six-Minute Walk Test (6MWT)	end of treatment +1 year (14 months from Baseline)	Total distance (feet) traveled over a 6 minute period.
Left Step Length	end of treatment (8 weeks from Baseline)	Mean left step length (cm) across two 2-minute walking trials
Right Step Width	end of treatment (8 weeks from Baseline)	Mean right step width (cm) across two 2-minute walking trials
Right Step Length	end of treatment (8 weeks from Baseline)	Mean right step length (cm) across two 2-minute walking trials
Left Step Width	end of treatment (8 weeks from Baseline)	Mean left step width (cm) across two 2-minute walking trials
Walking Cadence	end of treatment (8 weeks from Baseline)	Mean steps/minute across two 2-minute walking trials
Right Hip Range of Motion (sagittal plane)	end of treatment (8 weeks from Baseline)	Mean peak degree of right hip flexion across two 2-minute walking trials
Left Hip Range of Motion (coronal plane)	end of treatment (8 weeks from Baseline)	Mean peak degree of left hip abduction across two 2-minute walking trials
Right Stance Time	end of treatment (8 weeks from Baseline)	Mean time (in seconds) spent in stance phase on the right lower extremity across two 2-minute walking trials
Left Stance Time	end of treatment (8 weeks from Baseline)	Mean time (in seconds) spent in stance phase on the left lower extremity across two 2-minute walking trials
Right Swing Time	end of treatment (8 weeks from Baseline)	Mean time (in seconds) spent in swing phase on the right lower extremity across two 2-minute walking trials
Walking Speed	end of treatment (8 weeks from Baseline)	Mean m/s across two 2-minute walking trials
Left Swing Time	end of treatment (8 weeks from Baseline)	Mean time (in seconds) spent in swing phase on the left lower extremity across two 2-minute walking trials
Left Ankle Range of Motion	end of treatment (8 weeks from Baseline)	Mean peak degree of left ankle dorsiflexion across two 2-minute walking trials
Right Ankle Range of Motion	end of treatment (8 weeks from Baseline)	Mean peak degree of right ankle dorsiflexion across two 2-minute walking trials
Left Hip Range of Motion (sagittal plane)	end of treatment (8 weeks from Baseline)	Mean peak degree of left hip flexion across two 2-minute walking trials
Left Hip Range of Motion (transverse plane)	end of treatment (8 weeks from Baseline)	Mean peak degree of left hip external rotation across two 2-minute walking trials
Right Hip Range of Motion (coronal plane)	end of treatment (8 weeks from Baseline)	Mean peak degree of right hip abduction across two 2-minute walking trials
Right Hip Range of Motion (transverse plane)	end of treatment (8 weeks from Baseline)	Mean peak degree of right hip external rotation across two 2-minute walking trials

Trial Locations

Locations (1)

Cleveland Clinic Main Campus; 🇺🇸 Cleveland, Ohio, United States