Fitness After Stroke Trial
People living with stroke have very low aerobic fitness, which can negatively impact brain health. Identifying the best exercise which includes exercise stimulus type (interval, continuous) or intensity, how hard to exercise (moderate, high) that benefit aerobic fitness, vascular health, and the brain's main blood vessels after stroke are unknown. This study is designed to determine the preliminary efficacy of high-volume HIIT to moderate intensity exercise using a seated stepper exercise device that allows the arms and legs to move back and forth.
Conditions:
🦠 Stroke 🦠 Stroke, Ischemic 🦠 Stroke Hemorrhagic
🗓️ Study Start (Actual) 3 July 2023
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 50
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Kansas City, Kansas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Both sexes between the age of 20-85 years at time of consent
    • * Chronic ischemic or hemorrhagic stroke 6 months to 5 years at consent. People with stroke and newly diagnosed cardiovascular complications had \>50% prevalence of recurrent stroke at 5 years. Index stroke or recurrent stroke on same side as index stroke will be allowed.
    • * Ability to walk over ground with assistive devices and no continuous physical assistance from another person to perform tests for gait speed and six-minute walk test
    • * Exercise continuously for minimum of 30 watts for 3 minutes on the recumbent stepper to demonstrate ability to perform the exercise test.
    • * No aerobic exercise contraindications or other safety/physical concerns during the submaximal exercise test.
    • * Able to communicate with investigators, follow 2-step command \& correctly answer consent comprehension questions
    • * Currently participating in less than 150 minutes of physical activity/week assessed by the Rapid Assessment of Physical Activity
    • * Stable blood pressure \& statin medication doses for 30 days prior to enrollment due to effects on vascular health/hemodynamics

    Exclusion Criteria:

    • * Hospitalization for cardiac or pulmonary disease within past 3 months
    • * Implanted pacemaker or defibrillator limiting exercise performance
    • * Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
    • * Reported pain that limits or interferes with activities of daily living and physical activity/exercise
    • * Severe LE spasticity (Ashworth \>2) due to inability to exercise
    • * Recent history (\<3 months) of illicit drug or alcohol abuse or diagnosis of significant mental illness
    • * Major post-stroke depression (Patient Health Questionnaire, PHQ-9 ≥ 1084)
    • * Currently participating in physical therapy targeting lower extremity function or another interventional study that may influence study outcomes
    • * Other significant neurologic, orthopedic or peripheral vascular conditions that would limit exercise participation
    • * Oxygen-dependent chronic obstructive pulmonary disease
    • * Diagnosis of other neurological disease (Multiple Sclerosis, Alzheimer's disease, Parkinson's disease)
    • * Self report pregnancy
Ages Eligible for Study: 20 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 19 June 2023
  • First Submitted that Met QC Criteria 6 July 2023
  • First Posted 7 July 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 4 October 2023
  • Last Update Posted 6 October 2023
  • Last Verified October 2023