Cost-effectiveness of Forced Aerobic Exercise for Stroke Rehabilitation

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Vascular Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases
• Intervention / Treatment: Behavioral: Aerobic Exercise; Behavioral: Upper Extremity Repetitive Task Practice

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aerobic Exercise & Repetitive Task Practice; Participants will perform the following: 45 minutes of cycling; 45 minutes of upper extremity repetitive arm exercises	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; Behavioral: Upper Extremity Repetitive Task Practice; Repetitive arm exercises
Active Comparator: Upper Extremity Repetitive Task Practice Only; Participants will perform the following: 1. 90 minutes of upper extremity repetitive arm exercises	Behavioral: Upper Extremity Repetitive Task Practice; Repetitive arm exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment (FMA)	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.	Baseline
Fugl-Meyer Assessment (FMA)	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.	midpoint (4 weeks from Baseline)
Fugl-Meyer Assessment (FMA)	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.	end of treatment (8 weeks from Baseline)
Fugl-Meyer Assessment (FMA)	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.	end of treatment +4 weeks (12 weeks from Baseline)
Fugl-Meyer Assessment (FMA)	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.	end of treatment +6 months (8 months from Baseline)
Fugl-Meyer Assessment (FMA)	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.	end of treatment +1 year (14 months from Baseline)
Action Research Arm Test (ARAT)	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.	Baseline
Action Research Arm Test (ARAT)	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.	end of treatment (8 weeks from Baseline)
Action Research Arm Test (ARAT)	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.	end of treatment +4 weeks (12 weeks from Baseline)
Action Research Arm Test (ARAT)	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.	end of treatment +6 months (8 months from Baseline)
Action Research Arm Test (ARAT)	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.	end of treatment +1 year (14 months from Baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wolf Motor Function Test (WMFT)	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.	Baseline
Stroke Impact Scale (SIS)	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.	Baseline
Stroke Impact Scale (SIS)	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.	end of treatment (8 weeks from Baseline)
Stroke Impact Scale (SIS)	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.	end of treatment +6 months (8 months from Baseline)
Stroke Impact Scale (SIS)	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.	end of treatment +1 year (14 months from Baseline)
Patient-Reported Outcomes Measurement Information System (PROMIS-29)	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.	Baseline
Patient-Reported Outcomes Measurement Information System (PROMIS-29)	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.	end of treatment (8 weeks from Baseline)
Patient-Reported Outcomes Measurement Information System (PROMIS-29)	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.easured.	end of treatment +6 months (8 months from Baseline)
Patient-Reported Outcomes Measurement Information System (PROMIS-29)	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.	end of treatment +1 year (14 months from Baseline)
Center for Epidemiological Studies-Depression (CES-D)	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.	Baseline
Center for Epidemiological Studies-Depression (CES-D)	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.	end of treatment (8 weeks from Baseline)
Center for Epidemiological Studies-Depression (CES-D)	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.	end of treatment +6 months (8 months from Baseline)
Center for Epidemiological Studies-Depression (CES-D)	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.	end of treatment +1 year (14 months from Baseline)
Six-Minute Walk Test (6MWT)	The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.	Baseline
Six-Minute Walk Test (6MWT)	The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.	end of treatment (8 weeks)
Six-Minute Walk Test (6MWT)	The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.	end of treatment +4 weeks (12 weeks from Baseline)
Six-Minute Walk Test (6MWT)	The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.	end of treatment +6 months (8 months from Baseline)
Six-Minute Walk Test (6MWT)	The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.	end of treatment +1 year (14 months from Baseline)
Paretic Step Length	Mean Paretic step length (cm) across two 2-minute walking trials	Baseline
Non-Paretic Step Length	Mean Non-Paretic step length (cm) across two 2-minute walking trials	Baseline
Paretic Step Length	Mean Paretic step length (cm) across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Non-Paretic Step Length	Mean Non-Paretic step length (cm) across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Non-Paretic Single Limb Percentage	Percentage of gait cycle spent in single limb support	Baseline
Non-Paretic Single Limb Percentage	Mean percentage of gait cycle spent in stance phase on the Non-Paretic lower extremity across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Modified Rankin Scale	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; No significant disability despite symptoms; able to carry out all usual duties and activities; Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; Moderate disability; requiring some help, but able to walk without assistance; Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; Severe disability; bedridden, incontinent and requiring constant nursing care and attention; Dead	Baseline
Modified Rankin Scale	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; No significant disability despite symptoms; able to carry out all usual duties and activities; Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; Moderate disability; requiring some help, but able to walk without assistance; Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; Severe disability; bedridden, incontinent and requiring constant nursing care and attention; Dead	end of treatment (8 weeks from Baseline)
Walking Cadence	Steps walked per minute during two 2-minute walking trials	Baseline
Walking Cadence	Steps walked per minute during two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Paretic Single Limb Percentage	Percentage of gait cycle spent in single limb support	Baseline
Paretic Single Limb Percentage	Percentage of gait cycle spent in single limb support	end of treatment (8 weeks from Baseline)
Paretic Knee Range of Motion	Mean peak degree of paretic knee flexion across two 2-minute walking trials	Baseline
Paretic Knee Range of Motion	Mean peak degree of paretic knee flexion across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Non-Paretic Knee Range of Motion	Mean peak degree of non-paretic knee flexion across two 2-minute walking trials	Baseline
Non-Paretic Knee Range of Motion	Mean peak degree of non-paretic knee flexion across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Paretic Ankle Range of Motion	Mean peak degree of paretic ankle dorsiflexion across two 2-minute walking trials	Baseline
Paretic Ankle Range of Motion	Mean peak degree of paretic ankle dorsiflexion across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Non-Paretic Ankle Range of Motion	Non-Paretic peak degree of non-paretic dorsiflexion across two 2-minute walking trials	Baseline
Non-Paretic Ankle Range of Motion	Mean peak degree of non-paretic ankle dorsiflexion across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Paretic Hip Range of Motion (Sagittal Plane)	Mean peak degree of paretic hip flexion across two 2-minute walking trials	Baseline
Paretic Hip Range of Motion (Sagittal Plane)	Mean peak degree of paretic hip flexion across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Non-Paretic Hip Range of Motion (Sagittal Plane)	Mean peak degree of non-paretic hip flexion across two 2-minute walking trials	Baseline
Non-Paretic Hip Range of Motion (Sagittal Plane)	Mean peak degree of non-paretic hip flexion across two 2-minute walking trials	end of treatment (8 weeks from Baseline)
Wolf Motor Function Test (WMFT) Functional Ability Score	The Wolf Motor Function Test Functional Ability Score quantifies movement quality. Scores range from 0-75, with higher scores indicating a better outcome.	End of Treatment (8 weeks from baseline)
Wolf Motor Function Test (WMFT) Grip Strength	The Wolf Motor Function Test includes Grip strength measured by dynamometer	End of Treatment (8 weeks from baseline)
Wolf Motor Function Test (WMFT) Weight to Box	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.	End of Treatment (8 weeks from baseline)
Wolf Motor Function Test (WMFT)	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.	end of treatment (8 weeks from baseline)
Wolf Motor Function Test (WMFT) Functional Ability Score	The WMFT Functional Ability Score quantifies movement quality. Scores range from 0-75, with higher scores indicating a better outcome.	Baseline
Wolf Motor Function Test (WMFT) Grip Strength	The Wolf Motor Function Test includes Grip strength measured by dynamometer	baseline
Wolf Motor Function Test (WMFT) Weight to Box	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.	baseline
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity	The Patient-Reported Outcomes Measurement Information System includes pain rated on a 0-10 scale with higher scores indicative of greater pain.	End of Treatment (8 weeks following baseline)
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity	The Patient-Reported Outcomes Measurement Information System includes pain rated rated on a 0-10 scale with higher scores indicative of greater pain.	Baseline
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity	The Patient-Reported Outcomes Measurement Information System includes pain rated on a 0-10 scale with higher scores indicative of greater pain.	end of treatment + 6 months (8 months from baseline)
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity	The Patient-Reported Outcomes Measurement Information System includes pain rated on a 0-10 scale with higher scores indicative of greater pain.	end of treatment + 12 months (14 months from baseline)

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Susan Linder, DPT, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2019
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: stroke; aerobic exercise; upper extremity; arm function; forced exercise; repetitive task practice
• Additional Relevant MeSH Terms: Stroke; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Nervous System Diseases; Central Nervous System Diseases; Cerebrovascular Disorders
• Other Study ID Numbers: 18-734

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No