HIT-Stroke Trial 2

Official title

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

Overview

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.

Interventions

• Behavioral Moderate-Intensity Aerobic Training
  Overground and treadmill walking with speed continuously adjusted to maintain a target heart rate of 40 +/- 5% heart rate reserve, progressing up to 55 +/- 5% heart rate reserve.
• Behavioral High-Intensity Interval Training
  Overground and treadmill walking with 30 second bursts at maximum speed alternated with 30-60 second passive recovery periods. Intended to achieve a target average heart rate above 60% heart rate reserve.

Primary outcome measures

• 6-Minute Walk Test Distance [Time frame: Change from Baseline to 12 weeks]

Secondary outcome measures (6)

• 6-Minute Walk Test Distance [Time frame: Change from Baseline to 3 month follow up]
• Self-Selected Gait Speed [Time frame: Change from Baseline to 12 weeks]
• Fastest Gait Speed [Time frame: Change from Baseline to 12 weeks]
• PROMIS-Fatigue Scale version 8a [Time frame: Change from Baseline to 3 month follow up]
• Aerobic Capacity [Time frame: Change from Baseline to 12 weeks]
• EuroQol-5D-5L [Time frame: Change from Baseline to 3 month follow up]

Eligibility criteria

Inclusion 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 3 centers

• University of Delaware — Newark
• University of Kansas Medical Center — Kansas City
• University of Cincinnati — Cincinnati

Publications

• Pressler D, Schwab-Farrell SM, Awosika OO, Reisman DS, Billinger SA, Riley MA, Boyne P. Predicting Musculoskeletal Adverse Events During Moderate- to High-Intensity Walking Training in Chronic Stroke. medRxiv [Preprint]. 2026 Apr 18:2026.04.16.26351040. doi: 10.64898/2026.04.16.26351040. PMID 42064927
• Garrity C, Reisman DS, Billinger SA, Pressler D, Wagner E, Awosika O, Bartsch BL, Briton-Carpenter A, Carl D, Engler A, Foster J, Kim J, McCartney K, Moores A, Sucharew H, Thompson E, Walters K, Wasik E, Wright H, Yeazell M, Boyne P. Protocol for the HIT-Stroke Trial 2 randomized controlled trial: Moderate-intensity exercise versus high-intensity interval training to determine the optimal training PMID 40766122

Identifiers

NCT: NCT06268041 · 427659 · R01HD093694

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗