HIT-Stroke Trial 2
- Conditions
- Stroke
- Interventions
- Behavioral: Moderate-Intensity Aerobic TrainingBehavioral: High-Intensity Interval Training
- Registration Number
- NCT06268041
- Lead Sponsor
- University of Cincinnati
- 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 3-month follow up (3moPOST), by raters who are unaware of the participant randomization.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 156
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moderate-Intensity Aerobic Training Moderate-Intensity Aerobic Training - High-Intensity Interval Training High-Intensity Interval Training -
- Primary Outcome Measures
Name Time Method 6-Minute Walk Test Distance Change from Baseline to 12 weeks Total distance walked in 6 minutes in meters
- Secondary Outcome Measures
Name Time Method Fastest Gait Speed Change from Baseline to 12 weeks From 10-meter walk test at fastest speed, in meters per second
PROMIS-Fatigue Scale version 8a Change from Baseline to 3 month follow up 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.
6-Minute Walk Test Distance Change from Baseline to 3 month follow up Total distance walked in 6 minutes in meters
Aerobic Capacity Change from Baseline to 12 weeks Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute
Self-Selected Gait Speed Change from Baseline to 12 weeks From 10-meter walk test at self-selected speed, in meters per second
EuroQol-5D-5L Change from Baseline to 3 month follow up 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.
Trial Locations
- Locations (3)
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of Delaware
🇺🇸Newark, Delaware, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States