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Clinical Trial NCT06268041 (HST2) for Stroke is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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HIT-Stroke Trial 2 (HST2) 156 Exercise-Based

Recruiting
Clinical Trial NCT06268041 (HST2) is an interventional study for Stroke that is recruiting. It started on 9 February 2024 with plans to enroll 156 participants. Led by University of Cincinnati, it is expected to complete by 1 April 2028. The latest data from ClinicalTrials.gov was last updated on 9 January 2025.
Brief Summary
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...Show More
Official Title

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

Conditions
Stroke
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
NCT ID Number
NCT06268041
Start Date (Actual)
2024-02-09
Last Update Posted
2025-01-09
Completion Date (Estimated)
2028-04
Enrollment (Estimated)
156
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
gait
aerobic
locomotion
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorModerate-Intensity Aerobic Training
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.
ExperimentalHigh-Intensity Interval Training
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
Outcome MeasureMeasure DescriptionTime Frame
6-Minute Walk Test Distance
Total distance walked in 6 minutes in meters
Change from Baseline to 12 weeks
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
6-Minute Walk Test Distance
Total distance walked in 6 minutes in meters
Change from Baseline to 3 month follow up
Self-Selected Gait Speed
From 10-meter walk test at self-selected speed, in meters per second
Change from Baseline to 12 weeks
Fastest Gait Speed
From 10-meter walk test at fastest speed, in meters per second
Change from Baseline to 12 weeks
PROMIS-Fatigue Scale version 8a
An 8-item self-report questionnaire about symptoms of fatigue. Each item is rated from 1-5. Items are combined to obtain a total T score, where higher scores indicate greater fatigue.
Change from Baseline to 3 month follow up
Aerobic Capacity
Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute
Change from Baseline to 12 weeks
EuroQol-5D-5L
A 6-item questionnaire about quality of life, including: mobility, self-care, usual activities, pain/discomfort, anxiety/depression and overall health. Each item is scored from 1 to 5, where lower scores indicate greater quality of life. A total 'misery score' will be calculated by averaging the scores for each item.
Change from Baseline to 3 month follow up
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
30 Years
Eligible Sexes
All
  • 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
University of Cincinnati logoUniversity of Cincinnati
Study Responsible Party
Pierce Boyne, Principal Investigator, Associate Professor, University of Cincinnati
Study Central Contact
Contact: Madison Yeazell, 513-558-7487, [email protected]
3 Study Locations in 1 Countries

Delaware

University of Delaware, Newark, Delaware, 19713, United States
Jane Diehl, Contact, [email protected]
Darcy Reisman, PT, PhD, Principal Investigator
Recruiting

Kansas

University of Kansas Medical Center, Kansas City, Kansas, 66160, United States
Sasha Moores, Contact, 913-588-2697, [email protected]
Sandra Billinger, PT, PhD, Principal Investigator
Recruiting

Ohio

University of Cincinnati, Cincinnati, Ohio, 45267, United States
Madison Yeazell, Contact, 513-558-7487, [email protected]
Recruiting