Actively Recruiting
HIT-Stroke Trial 2
Led by University of Cincinnati · Updated on 2026-05-01
156
Participants Needed
3
Research Sites
216 weeks
Total Duration
On this page
Sponsors
U
University of Cincinnati
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HIT-Stroke Trial 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 less than 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 60.13m/s (0.3 mph)
- Stable cardiovascular condition (AHA class B, allowing for aerobic capacity less than 6 metabolic equivalents)
- Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions
You will not qualify if you...
- 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 without recent (past year) negative definitive clinical testing
- Hospitalization for cardiac or pulmonary disease within past 3 months
- Implanted pacemaker or defibrillator with an upper heart rate limit interfering with exercise testing or prescription, or unknown limit
- Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
- Severe lower limb spasticity (Ashworth greater than 2)
- Known recent history (less than 3 months) of unstable substance abuse or unstable mental illness
- Major post-stroke depression (PHQ-9 score of 10 or more) without depression management by a health care provider
- Currently participating in physical therapy or another interventional study targeting walking function
- Recent (less than 2 weeks) or planned changes in lower limb orthotic or spasticity management
- Foot drop or lower limb joint instability without adequate stabilizing device
- 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
- Pregnancy
- Previous exposure to fast treadmill walking (more than 3 cumulative hours) in the past year
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
University of Delaware
Newark, Delaware, United States, 19713
Actively Recruiting
2
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
3
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
Research Team
A
Audrey Nicoloff
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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