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Fitness After Stroke Trial

Launched by UNIVERSITY OF KANSAS MEDICAL CENTER · Jul 6, 2023

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

Exercise Cerebrovascular Cardiovascular Walking Aerobic Fitness Brain

ClinConnect Summary

The Fitness After Stroke Trial is studying how different types and intensities of exercise can help improve fitness and brain health in people who have had a stroke. The researchers want to find out if high-volume high-intensity interval training (HIIT) or moderate-intensity exercise using a seated stepper can improve aerobic fitness and support the health of blood vessels in the brain after a stroke. This trial is open to adults aged 20 to 85 who have had a stroke at least six months ago and can walk with some assistance.

If you decide to participate, you’ll be involved in exercise sessions that help assess your fitness and improve your health. To join, you should be able to exercise on a recumbent stepper, which is a machine that allows your arms and legs to move back and forth while seated. You should currently do less than 150 minutes of physical activity each week and have stable blood pressure. However, certain conditions, like severe pain or recent hospitalizations, might make you ineligible. This trial is a great opportunity to contribute to understanding how exercise can enhance recovery and health after a stroke.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Both sexes between the age of 20-85 years at time of consent
  • Chronic ischemic or hemorrhagic stroke 6 months to 15 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
  • 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

About University Of Kansas Medical Center

The University of Kansas Medical Center (KUMC) is a leading academic medical institution dedicated to advancing healthcare through innovative research, education, and clinical practice. As a prominent clinical trial sponsor, KUMC leverages its extensive expertise in diverse medical fields to conduct rigorous clinical research aimed at improving patient outcomes and developing new treatment modalities. With a commitment to ethical standards and patient safety, KUMC collaborates with multidisciplinary teams to facilitate groundbreaking studies that address significant health challenges, ultimately contributing to the advancement of medical knowledge and the enhancement of community health.

Locations

Kansas City, Kansas, United States

Patients applied

0 patients applied

Trial Officials

Sandra A Billinger, PhD

Principal Investigator

KU Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported