RECRUITING

Fitness After Stroke Trial

Conditions

Stroke Stroke, Ischemic Stroke Hemorrhagic exercise cerebrovascular cardiovascular walking aerobic fitness brain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Investigating Exercise Prescription Parameters on Aerobic Fitness and Vascular Health After Stroke: a Pilot Study

Quick Facts

Study Start:2023-07-03

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05936008

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Sandra A Billinger, PhD

CONTACT

913-945-6685

sbillinger@kumc.edu

Sasha Moores

CONTACT

913-588-2697

smoores@kumc.edu

Principal Investigator

Sandra A Billinger, PhD

PRINCIPAL_INVESTIGATOR

KU Medical Center

Study Locations (Sites)

University of Kansas Medical Center

Kansas City, Kansas, 66160

United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

Sandra A Billinger, PhD, PRINCIPAL_INVESTIGATOR, KU Medical Center

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

Study Start Date2023-07-03

Study Completion Date2025-12

Study Record Updates

Study Start Date2023-07-03

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

exercise
cerebrovascular
cardiovascular
walking
aerobic fitness
brain

Additional Relevant MeSH Terms

Stroke
Stroke, Ischemic
Stroke Hemorrhagic