HIT-Stroke Trial 2: Walking Exercises After Stroke

This study is for people aged 30-85 who have had a stroke at least six months ago and still have difficulty walking. You would be randomly assigned to one of two walking exercise programs: Moderate-Intensity Aerobic Training or High-Intensity Interval Training. Both programs involve walking on a treadmill or overground with a physical therapist for 45 minutes, three times a week, for 12 weeks. The main goal is to see how these exercises affect your walking distance, measured by a 6-Minute Walk Test. The study aims to enroll 156 participants, but its current status is unclear.

Study design: This study is an interventional trial that will randomly assign 156 participants to one of two walking exercise programs.
What's involved: You would participate in individual walking exercise sessions with a physical therapist for 45 minutes, three times a week, for 12 weeks. Walking function will be assessed at the beginning, after 4, 8, and 12 weeks of training.
Compensation: Not stated in the trial record.
Follow-up: Your walking function will be assessed again three months after the training period ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

HIT-Stroke Trial 2

Recruiting

NAAges 30–85InterventionalTreatment

University of Cincinnati

~156 participants

Updated 2026-05-01 on ClinicalTrials.gov

What's tested:Moderate-Intensity Aerobic TrainingHigh-Intensity Interval Training

At a glance

Recruiting sites

3 of 3 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

6-Minute Walk Test Distance

Measured over Change from Baseline to 12 weeks

Conditions

Stroke

NCT06268041

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

University of Cincinnati
Cincinnati, Ohiostudy coordinator listed
Recruiting
University of Delaware
Newark, Delawarestudy coordinator listed
Recruiting
University of Kansas Medical Center
Kansas City, Kansasstudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Audrey Nicoloff

[email protected]

513-558-7487

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

6-Minute Walk Test DistanceChange from Baseline to 12 weeks
Total distance walked in 6 minutes in meters

Trialytics