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Completed

NCT Number: NCT03819764

Cost-effectiveness of Forced Aerobic Exercise for Stroke Rehabilitation

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Behavioral

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

Behavioral

Repetitive arm exercises

Primary outcomes

  1. Fugl-Meyer Assessment (FMA)

    Time frame: 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.

  2. Fugl-Meyer Assessment (FMA)

    Time frame: midpoint (4 weeks 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.

  3. Fugl-Meyer Assessment (FMA)

    Time frame: end of treatment (8 weeks 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.

  4. Fugl-Meyer Assessment (FMA)

    Time frame: end of treatment +4 weeks (12 weeks 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.

  5. Fugl-Meyer Assessment (FMA)

    Time frame: end of treatment +6 months (8 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.

  6. Fugl-Meyer Assessment (FMA)

    Time frame: 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.

  7. Action Research Arm Test (ARAT)

    Time frame: 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.

  8. Action Research Arm Test (ARAT)

    Time frame: end of treatment (8 weeks 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.

  9. Action Research Arm Test (ARAT)

    Time frame: end of treatment +4 weeks (12 weeks 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.

  10. Action Research Arm Test (ARAT)

    Time frame: end of treatment +6 months (8 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.

  11. Action Research Arm Test (ARAT)

    Time frame: 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 outcomes

  1. Wolf Motor Function Test (WMFT)

    Time frame: 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.

  2. Stroke Impact Scale (SIS)

    Time frame: 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.

  3. Stroke Impact Scale (SIS)

    Time frame: end of treatment (8 weeks 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.

  4. Stroke Impact Scale (SIS)

    Time frame: end of treatment +6 months (8 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.

  5. Stroke Impact Scale (SIS)

    Time frame: 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.

  6. Patient-Reported Outcomes Measurement Information System (PROMIS-29)

    Time frame: 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.

  7. Patient-Reported Outcomes Measurement Information System (PROMIS-29)

    Time frame: end of treatment (8 weeks 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.

  8. Patient-Reported Outcomes Measurement Information System (PROMIS-29)

    Time frame: end of treatment +6 months (8 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.easured.

  9. Patient-Reported Outcomes Measurement Information System (PROMIS-29)

    Time frame: 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.

  10. Center for Epidemiological Studies-Depression (CES-D)

    Time frame: 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.

  11. Center for Epidemiological Studies-Depression (CES-D)

    Time frame: end of treatment (8 weeks 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.

  12. Center for Epidemiological Studies-Depression (CES-D)

    Time frame: end of treatment +6 months (8 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.

  13. Center for Epidemiological Studies-Depression (CES-D)

    Time frame: 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.

  14. Six-Minute Walk Test (6MWT)

    Time frame: Baseline

    The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.

  15. Six-Minute Walk Test (6MWT)

    Time frame: end of treatment (8 weeks)

    The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.

  16. Six-Minute Walk Test (6MWT)

    Time frame: end of treatment +4 weeks (12 weeks from Baseline)

    The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.

  17. Six-Minute Walk Test (6MWT)

    Time frame: end of treatment +6 months (8 months from Baseline)

    The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.

  18. Six-Minute Walk Test (6MWT)

    Time frame: end of treatment +1 year (14 months from Baseline)

    The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.

  19. Paretic Step Length

    Time frame: Baseline

    Mean Paretic step length (cm) across two 2-minute walking trials

  20. Non-Paretic Step Length

    Time frame: Baseline

    Mean Non-Paretic step length (cm) across two 2-minute walking trials

  21. Paretic Step Length

    Time frame: end of treatment (8 weeks from Baseline)

    Mean Paretic step length (cm) across two 2-minute walking trials

  22. Non-Paretic Step Length

    Time frame: end of treatment (8 weeks from Baseline)

    Mean Non-Paretic step length (cm) across two 2-minute walking trials

  23. Non-Paretic Single Limb Percentage

    Time frame: Baseline

    Percentage of gait cycle spent in single limb support

  24. Non-Paretic Single Limb Percentage

    Time frame: 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

  25. Modified Rankin Scale

    Time frame: 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

    • 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

  26. Modified Rankin Scale

    Time frame: 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

    • 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

  27. Walking Cadence

    Time frame: Baseline

    Steps walked per minute during two 2-minute walking trials

  28. Walking Cadence

    Time frame: end of treatment (8 weeks from Baseline)

    Steps walked per minute during two 2-minute walking trials

  29. Paretic Single Limb Percentage

    Time frame: Baseline

    Percentage of gait cycle spent in single limb support

  30. Paretic Single Limb Percentage

    Time frame: end of treatment (8 weeks from Baseline)

    Percentage of gait cycle spent in single limb support

  31. Paretic Knee Range of Motion

    Time frame: Baseline

    Mean peak degree of paretic knee flexion across two 2-minute walking trials

  32. Paretic Knee Range of Motion

    Time frame: end of treatment (8 weeks from Baseline)

    Mean peak degree of paretic knee flexion across two 2-minute walking trials

  33. Non-Paretic Knee Range of Motion

    Time frame: Baseline

    Mean peak degree of non-paretic knee flexion across two 2-minute walking trials

  34. Non-Paretic Knee Range of Motion

    Time frame: end of treatment (8 weeks from Baseline)

    Mean peak degree of non-paretic knee flexion across two 2-minute walking trials

  35. Paretic Ankle Range of Motion

    Time frame: Baseline

    Mean peak degree of paretic ankle dorsiflexion across two 2-minute walking trials

  36. Paretic Ankle Range of Motion

    Time frame: end of treatment (8 weeks from Baseline)

    Mean peak degree of paretic ankle dorsiflexion across two 2-minute walking trials

  37. Non-Paretic Ankle Range of Motion

    Time frame: Baseline

    Non-Paretic peak degree of non-paretic dorsiflexion across two 2-minute walking trials

  38. Non-Paretic Ankle Range of Motion

    Time frame: end of treatment (8 weeks from Baseline)

    Mean peak degree of non-paretic ankle dorsiflexion across two 2-minute walking trials

  39. Paretic Hip Range of Motion (Sagittal Plane)

    Time frame: Baseline

    Mean peak degree of paretic hip flexion across two 2-minute walking trials

  40. Paretic Hip Range of Motion (Sagittal Plane)

    Time frame: end of treatment (8 weeks from Baseline)

    Mean peak degree of paretic hip flexion across two 2-minute walking trials

  41. Non-Paretic Hip Range of Motion (Sagittal Plane)

    Time frame: Baseline

    Mean peak degree of non-paretic hip flexion across two 2-minute walking trials

  42. Non-Paretic Hip Range of Motion (Sagittal Plane)

    Time frame: end of treatment (8 weeks from Baseline)

    Mean peak degree of non-paretic hip flexion across two 2-minute walking trials

  43. Wolf Motor Function Test (WMFT) Functional Ability Score

    Time frame: End of Treatment (8 weeks from baseline)

    The Wolf Motor Function Test Functional Ability Score quantifies movement quality. Scores range from 0-75, with higher scores indicating a better outcome.

  44. Wolf Motor Function Test (WMFT) Grip Strength

    Time frame: End of Treatment (8 weeks from baseline)

    The Wolf Motor Function Test includes Grip strength measured by dynamometer

  45. Wolf Motor Function Test (WMFT) Weight to Box

    Time frame: End of Treatment (8 weeks from 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.

  46. Wolf Motor Function Test (WMFT)

    Time frame: 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.

  47. Wolf Motor Function Test (WMFT) Functional Ability Score

    Time frame: Baseline

    The WMFT Functional Ability Score quantifies movement quality. Scores range from 0-75, with higher scores indicating a better outcome.

  48. Wolf Motor Function Test (WMFT) Grip Strength

    Time frame: baseline

    The Wolf Motor Function Test includes Grip strength measured by dynamometer

  49. Wolf Motor Function Test (WMFT) Weight to Box

    Time frame: 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.

  50. Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity

    Time frame: End of Treatment (8 weeks following baseline)

    The Patient-Reported Outcomes Measurement Information System includes pain rated on a 0-10 scale with higher scores indicative of greater pain.

  51. Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity

    Time frame: Baseline

    The Patient-Reported Outcomes Measurement Information System includes pain rated rated on a 0-10 scale with higher scores indicative of greater pain.

  52. Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity

    Time frame: end of treatment + 6 months (8 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.

  53. Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jan 29, 2019
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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