RECRUITING

HIT-Stroke Trial 2

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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 who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. Measures including walking function will be assessed at baseline (PRE), after 4, 8 and 12 weeks of training (12WK) and at 3-month follow up (3moPOST), by raters who are unaware of the participant randomization.

Official Title

Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover Walking Post-Stroke: HIT-Stroke Trial 2

Quick Facts

Study Start:2024-02-09

Study Completion:2028-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06268041

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:30 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age 30-85 years at time of consenting * Hemiparesis from ischemic and/or hemorrhagic strokes * Most recent stroke for which participant sought treatment, at least 6 months prior to study consent * Walking speed \<1.0 m/s on the 10-meter walk test * Able to walk 10m over ground with assistive devices as needed and no continuous physical assistance from another person (guarding and intermittent assistance for loss of balance allowed) * Able to walk at least 3 minutes on the treadmill at ≥0.13m/s (0.3 mph) * Stable cardiovascular condition (AHA class B, allowing for aerobic capacity \<6 metabolic equivalents) * Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions	* Exercise testing uninterpretable for ischemia or arrhythmia (e.g. resting ECG abnormality that makes exercise ECG uninterpretable for ischemia and no other clinical testing from the past year available to rule out these conditions) * Evidence of significant arrhythmia or myocardial ischemia on treadmill ECG graded exercise test in the absence of recent (past year) more definitive clinical testing (e.g. stress nuclear imaging) with negative result * Hospitalization for cardiac or pulmonary disease within past 3 months * Implanted pacemaker or defibrillator with an upper heart rate limit that would interfere with exercise testing or prescription, or with unknown limit * Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11) * Severe lower limb spasticity (Ashworth \>2) * Known recent history (\<3 months) of unstable substance abuse or unstable mental illness * Major post-stroke depression (Patient Health Questionnaire \[PHQ-9\] ≥ 10) in the absence of depression management by a health care provider * Currently participating in physical therapy or another interventional study targeting walking function * Recent (\<2 weeks) or planned changes in lower limb orthotic or spasticity management * Foot drop or lower limb joint instability without adequate stabilizing device, as assessed by a physical therapist * Clinically significant neurologic disorder other than stroke or unable to walk outside the home prior to stroke * Unable to walk outside the home prior to stroke * Other significant medical condition likely to limit improvement or jeopardize safety as assessed by a physical therapist (e.g. joint contracture, gait limited by pain) * Pregnancy * Previous exposure to fast treadmill walking (\>3 cumulative hours) in the past year

Inclusion Criteria

Exclusion Criteria

* Age 30-85 years at time of consenting
* Hemiparesis from ischemic and/or hemorrhagic strokes
* Most recent stroke for which participant sought treatment, at least 6 months prior to study consent
* Walking speed \<1.0 m/s on the 10-meter walk test
* Able to walk 10m over ground with assistive devices as needed and no continuous physical assistance from another person (guarding and intermittent assistance for loss of balance allowed)
* Able to walk at least 3 minutes on the treadmill at ≥0.13m/s (0.3 mph)
* Stable cardiovascular condition (AHA class B, allowing for aerobic capacity \<6 metabolic equivalents)
* Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions

* Exercise testing uninterpretable for ischemia or arrhythmia (e.g. resting ECG abnormality that makes exercise ECG uninterpretable for ischemia and no other clinical testing from the past year available to rule out these conditions)
* Evidence of significant arrhythmia or myocardial ischemia on treadmill ECG graded exercise test in the absence of recent (past year) more definitive clinical testing (e.g. stress nuclear imaging) with negative result
* Hospitalization for cardiac or pulmonary disease within past 3 months
* Implanted pacemaker or defibrillator with an upper heart rate limit that would interfere with exercise testing or prescription, or with unknown limit
* Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
* Severe lower limb spasticity (Ashworth \>2)
* Known recent history (\<3 months) of unstable substance abuse or unstable mental illness
* Major post-stroke depression (Patient Health Questionnaire \[PHQ-9\] ≥ 10) in the absence of depression management by a health care provider
* Currently participating in physical therapy or another interventional study targeting walking function
* Recent (\<2 weeks) or planned changes in lower limb orthotic or spasticity management
* Foot drop or lower limb joint instability without adequate stabilizing device, as assessed by a physical therapist
* Clinically significant neurologic disorder other than stroke or unable to walk outside the home prior to stroke
* Unable to walk outside the home prior to stroke
* Other significant medical condition likely to limit improvement or jeopardize safety as assessed by a physical therapist (e.g. joint contracture, gait limited by pain)
* Pregnancy
* Previous exposure to fast treadmill walking (\>3 cumulative hours) in the past year

Contacts and Locations

Study Contact

Madison Yeazell

CONTACT

513-558-7487

strokerecovery@uc.edu

Principal Investigator

Pierce Boyne, PT, DPT, PhD

PRINCIPAL_INVESTIGATOR

University of Cincinnati

Study Locations (Sites)

University of Delaware

Newark, Delaware, 19713

United States

University of Kansas Medical Center

Kansas City, Kansas, 66160

United States

Collaborators and Investigators

Sponsor: University of Cincinnati

Pierce Boyne, PT, DPT, PhD, PRINCIPAL_INVESTIGATOR, University of Cincinnati

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 Date2024-02-09

Study Completion Date2028-04

Study Record Updates

Study Start Date2024-02-09

Study Completion Date2028-04

Terms related to this study

Keywords Provided by Researchers

gait
aerobic
locomotion

Additional Relevant MeSH Terms

Stroke