Cost-effectiveness of Forced Aerobic Exercise for Stroke Rehabilitation

Stroke Clinical Trial

Official title:

Cost-effectiveness and Efficacy of a Combined Intervention to Facilitate Motor Recovery Following Stroke

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03819764
• Other study ID #: 18-734
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 11, 2019
• Est. completion date: January 31, 2025

Study information

• Verified date: March 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Cardiovascular Diseases
• Central Nervous System Diseases
• Cerebrovascular Disorders
• Nervous System Diseases
• Stroke
• Vascular Diseases

Intervention

Behavioral:
• Aerobic Exercise
Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed
• Upper Extremity Repetitive Task Practice
Repetitive arm exercises

Locations

Country	Name	City	State
United States	Cleveland Clinic Main Campus	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment (FMA)	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.	Baseline
Primary	Fugl-Meyer Assessment (FMA)	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.	midpoint (4 weeks from Baseline)
Primary	Fugl-Meyer Assessment (FMA)	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.	end of treatment (8 weeks from Baseline)
Primary	Fugl-Meyer Assessment (FMA)	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.	end of treatment +4 weeks (12 weeks from Baseline)
Primary	Fugl-Meyer Assessment (FMA)	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.	end of treatment +6 months (8 months from Baseline)
Primary	Fugl-Meyer Assessment (FMA)	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.	end of treatment +1 year (14 months from Baseline)
Primary	Action Research Arm Test (ARAT)	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.	Baseline
Primary	Action Research Arm Test (ARAT)	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.	end of treatment (8 weeks from Baseline)
Primary	Action Research Arm Test (ARAT)	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.	end of treatment +4 weeks (12 weeks from Baseline)
Primary	Action Research Arm Test (ARAT)	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.	end of treatment +6 months (8 months from Baseline)
Primary	Action Research Arm Test (ARAT)	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.	end of treatment +1 year (14 months from Baseline)
Secondary	Wolf Motor Function Test (WMFT)	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.	Baseline
Secondary	Wolf Motor Function Test (WMFT)	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.	end of treatment (8 weeks from Baseline)
Secondary	Stroke Impact Scale (SIS)	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.	Baseline
Secondary	Stroke Impact Scale (SIS)	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.	end of treatment (8 weeks from Baseline)
Secondary	Stroke Impact Scale (SIS)	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.	end of treatment +6 months (8 months from Baseline)
Secondary	Stroke Impact Scale (SIS)	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.	end of treatment +1 year (14 months from Baseline)
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS-29)	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.	Baseline
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS-29)	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.	end of treatment (8 weeks from Baseline)
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS-29)	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.	end of treatment +6 months (8 months from Baseline)
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS-29)	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.	end of treatment +1 year (14 months from Baseline)
Secondary	Center for Epidemiological Studies-Depression (CES-D)	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.	Baseline
Secondary	Center for Epidemiological Studies-Depression (CES-D)	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.	end of treatment (8 weeks from Baseline)
Secondary	Center for Epidemiological Studies-Depression (CES-D)	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.	end of treatment +6 months (8 months from Baseline)
Secondary	Center for Epidemiological Studies-Depression (CES-D)	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.	end of treatment +1 year (14 months from Baseline)
Secondary	Six-Minute Walk Test (6MWT)	Total distance (feet) traveled over a 6 minute period.	Baseline
Secondary	Six-Minute Walk Test (6MWT)	Total distance (feet) traveled over a 6 minute period.	end of treatment (8 weeks)
Secondary	Six-Minute Walk Test (6MWT)	Total distance (feet) traveled over a 6 minute period.	end of treatment +4 weeks (12 weeks from Baseline)
Secondary	Six-Minute Walk Test (6MWT)	Total distance (feet) traveled over a 6 minute period.	end of treatment +6 months (8 months from Baseline)
Secondary	Six-Minute Walk Test (6MWT)	Total distance (feet) traveled over a 6 minute period.	end of treatment +1 year (14 months from Baseline)
Secondary	Modified Rankin Scale	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.	Baseline
Secondary	Modified Rankin Scale	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.	end of treatment (8 weeks from Baseline)
Secondary	Modified Rankin Scale	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.	end of treatment +6 months (8 months from Baseline)
Secondary	Modified Rankin Scale	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.	end of treatment +1 year (14 months from Baseline)
Secondary	Right Step Length	Mean right step length (cm) across two 2-minute walking trials	Baseline
Secondary	Right Step Length	Mean right step length (cm) across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Secondary	Left Step Length	Mean left step length (cm) across two 2-minute walking trials	Baseline
Secondary	Left Step Length	Mean left step length (cm) across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Secondary	Right Step Width	Mean right step width (cm) across two 2-minute walking trials	Baseline
Secondary	Right Step Width	Mean right step width (cm) across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Secondary	Left Step Width	Mean left step width (cm) across two 2-minute walking trials	Baseline
Secondary	Left Step Width	Mean left step width (cm) across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Secondary	Right Stance Time	Mean time (in seconds) spent in stance phase on the right lower extremity across two 2-minute walking trials	Baseline
Secondary	Right Stance Time	Mean time (in seconds) spent in stance phase on the right lower extremity across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Secondary	Left Stance Time	Mean time (in seconds) spent in stance phase on the left lower extremity across two 2-minute walking trials	Baseline
Secondary	Left Stance Time	Mean time (in seconds) spent in stance phase on the left lower extremity across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Secondary	Right Swing Time	Mean time (in seconds) spent in swing phase on the right lower extremity across two 2-minute walking trials	Baseline
Secondary	Right Swing Time	Mean time (in seconds) spent in swing phase on the right lower extremity across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Secondary	Left Swing Time	Mean time (in seconds) spent in swing phase on the left lower extremity across two 2-minute walking trials	Baseline
Secondary	Left Swing Time	Mean time (in seconds) spent in swing phase on the left lower extremity across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Secondary	Walking Speed	Mean m/s across two 2-minute walking trials	Baseline
Secondary	Walking Speed	Mean m/s across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Secondary	Walking Cadence	Mean steps/minute across two 2-minute walking trials	Baseline
Secondary	Walking Cadence	Mean steps/minute across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Secondary	Left Knee Range of Motion	Mean peak degree of left knee flexion across two 2-minute walking trials	Baseline
Secondary	Left Knee Range of Motion	Mean peak degree of left knee flexion across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Secondary	Right Knee Range of Motion	Mean peak degree of right knee flexion across two 2-minute walking trials	Baseline
Secondary	Right Knee Range of Motion	Mean peak degree of right knee flexion across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Secondary	Left Ankle Range of Motion	Mean peak degree of left ankle dorsiflexion across two 2-minute walking trials	Baseline
Secondary	Left Ankle Range of Motion	Mean peak degree of left ankle dorsiflexion across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Secondary	Right Ankle Range of Motion	Mean peak degree of right ankle dorsiflexion across two 2-minute walking trials	Baseline
Secondary	Right Ankle Range of Motion	Mean peak degree of right ankle dorsiflexion across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Secondary	Left Hip Range of Motion (sagittal plane)	Mean peak degree of left hip flexion across two 2-minute walking trials	Baseline
Secondary	Left Hip Range of Motion (sagittal plane)	Mean peak degree of left hip flexion across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Secondary	Right Hip Range of Motion (sagittal plane)	Mean peak degree of right hip flexion across two 2-minute walking trials	Baseline
Secondary	Right Hip Range of Motion (sagittal plane)	Mean peak degree of right hip flexion across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Secondary	Left Hip Range of Motion (coronal plane)	Mean peak degree of left hip abduction across two 2-minute walking trials	Baseline
Secondary	Left Hip Range of Motion (coronal plane)	Mean peak degree of left hip abduction across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Secondary	Right Hip Range of Motion (coronal plane)	Mean peak degree of right hip abduction across two 2-minute walking trials	Baseline
Secondary	Right Hip Range of Motion (coronal plane)	Mean peak degree of right hip abduction across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Secondary	Left Hip Range of Motion (transverse plane)	Mean peak degree of left hip external rotation across two 2-minute walking trials	Baseline
Secondary	Left Hip Range of Motion (transverse plane)	Mean peak degree of left hip external rotation across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Secondary	Right Hip Range of Motion (transverse plane)	Mean peak degree of right hip external rotation across two 2-minute walking trials	Baseline
Secondary	Right Hip Range of Motion (transverse plane)	Mean peak degree of right hip external rotation across two 2-minute walking trials	end of treatment (8 weeks from Baseline)