[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06268041":3,"trial-entities:NCT06268041":159,"trial-summary:NCT06268041":162},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":41,"secondary_outcomes":46,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":96,"locations":99,"central_contacts":144,"overall_officials":147,"references":150,"see_also_links":158},"NCT06268041","427659","HIT-Stroke Trial 2","Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover Walking Post-Stroke: HIT-Stroke Trial 2","RECRUITING","2028-04","2026-04","2026-05-01","2024-02-09","University of Cincinnati","OTHER",true,"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\u002Fweek 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.",null,[19],"Stroke",[21,22,23],"gait","aerobic","locomotion","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},156,"ESTIMATED",[32,37],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","Moderate-Intensity Aerobic Training","Overground and treadmill walking with speed continuously adjusted to maintain a target heart rate of 40 +\u002F- 5% heart rate reserve, progressing up to 55 +\u002F- 5% heart rate reserve.",[34],{"type":33,"name":38,"description":39,"armGroupLabels":40},"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.",[38],[42],{"measure":43,"description":44,"timeFrame":45},"6-Minute Walk Test Distance","Total distance walked in 6 minutes in meters","Change from Baseline to 12 weeks",[47,49,52,55,58,61],{"measure":43,"description":44,"timeFrame":48},"Change from Baseline to 3 month follow up",{"measure":50,"description":51,"timeFrame":45},"Self-Selected Gait Speed","From 10-meter walk test at self-selected speed, in meters per second",{"measure":53,"description":54,"timeFrame":45},"Fastest Gait Speed","From 10-meter walk test at fastest speed, in meters per second",{"measure":56,"description":57,"timeFrame":48},"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.",{"measure":59,"description":60,"timeFrame":45},"Aerobic Capacity","Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute",{"measure":62,"description":63,"timeFrame":48},"EuroQol-5D-5L","A 6-item questionnaire about quality of life, including: mobility, self-care, usual activities, pain\u002Fdiscomfort, anxiety\u002Fdepression 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.","ALL","30 Years","85 Years",false,{"inclusion":69,"exclusion":78,"raw_text":95},[70,71,72,73,74,75,76,77],"Age 30-85 years at time of consenting","Hemiparesis from ischemic and\u002For hemorrhagic strokes","Most recent stroke for which participant sought treatment, at least 6 months prior to study consent","Walking speed \\\u003C1.0 m\u002Fs 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\u002Fs (0.3 mph)","Stable cardiovascular condition (AHA class B, allowing for aerobic capacity \\\u003C6 metabolic equivalents)","Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions",[79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94],"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 (\\\u003C3 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 (\\\u003C2 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","Inclusion Criteria:\n\n* Age 30-85 years at time of consenting\n* Hemiparesis from ischemic and\u002For hemorrhagic strokes\n* Most recent stroke for which participant sought treatment, at least 6 months prior to study consent\n* Walking speed \\\u003C1.0 m\u002Fs on the 10-meter walk test\n* 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)\n* Able to walk at least 3 minutes on the treadmill at ≥0.13m\u002Fs (0.3 mph)\n* Stable cardiovascular condition (AHA class B, allowing for aerobic capacity \\\u003C6 metabolic equivalents)\n* Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions\n\nExclusion Criteria:\n\n* 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)\n* 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\n* Hospitalization for cardiac or pulmonary disease within past 3 months\n* Implanted pacemaker or defibrillator with an upper heart rate limit that would interfere with exercise testing or prescription, or with unknown limit\n* Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)\n* Severe lower limb spasticity (Ashworth \\>2)\n* Known recent history (\\\u003C3 months) of unstable substance abuse or unstable mental illness\n* Major post-stroke depression (Patient Health Questionnaire \\[PHQ-9\\] ≥ 10) in the absence of depression management by a health care provider\n* Currently participating in physical therapy or another interventional study targeting walking function\n* Recent (\\\u003C2 weeks) or planned changes in lower limb orthotic or spasticity management\n* Foot drop or lower limb joint instability without adequate stabilizing device, as assessed by a physical therapist\n* Clinically significant neurologic disorder other than stroke or unable to walk outside the home prior to stroke\n* Unable to walk outside the home prior to stroke\n* 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)\n* Pregnancy\n* Previous exposure to fast treadmill walking (\\>3 cumulative hours) in the past year",[97,98],"ADULT","OLDER_ADULT",[100,117,132],{"facility":101,"status":8,"city":102,"state":103,"zip":104,"country":105,"contacts":106,"geoPoint":114},"University of Delaware","Newark","Delaware","19713","United States",[107,111],{"name":108,"role":109,"email":110},"Jane Diehl","CONTACT","strokestudies@udel.edu",{"name":112,"role":113},"Darcy Reisman, PT, PhD","PRINCIPAL_INVESTIGATOR",{"lat":115,"lon":116},39.68372,-75.74966,{"facility":118,"status":8,"city":119,"state":120,"zip":121,"country":105,"contacts":122,"geoPoint":129},"University of Kansas Medical Center","Kansas City","Kansas","66160",[123,127],{"name":124,"role":109,"phone":125,"email":126},"Sasha Moores","913-588-2697","reachlab@kumc.edu",{"name":128,"role":113},"Sandra Billinger, PT, PhD",{"lat":130,"lon":131},39.11417,-94.62746,{"facility":13,"status":8,"city":133,"state":134,"zip":135,"country":105,"contacts":136,"geoPoint":141},"Cincinnati","Ohio","45267",[137],{"name":138,"role":109,"phone":139,"email":140},"Audrey Nicoloff","513-558-7487","strokerecovery@uc.udu",{"lat":142,"lon":143},39.12711,-84.51439,[145],{"name":138,"role":109,"phone":139,"email":146},"strokerecovery@uc.edu",[148],{"name":149,"affiliation":13,"role":113},"Pierce Boyne, PT, DPT, PhD",[151,155],{"pmid":152,"type":153,"citation":154},"42064927","DERIVED","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\u002F2026.04.16.26351040.",{"pmid":156,"type":153,"citation":157},"40766122","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 intensity for walking rehabilitation in chronic stroke. medRxiv [Preprint]. 2025 Jul 31:2025.07.30.25332470. doi: 10.1101\u002F2025.07.30.25332470.",[],{"nct_id":4,"conditions":160,"biomarkers":161},[19],[],{"nct_id":4,"found":15,"summary":163,"prompt_version":173},{"design":164,"status":165,"heading":166,"summary":167,"follow_up":168,"word_count":169,"commitments":170,"compensation":171,"drugs_mentioned":172},"This study is an interventional trial that will randomly assign 156 participants to one of two walking exercise programs.","completed","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.","Your walking function will be assessed again three months after the training period ends.",96,"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.","Not stated in the trial record.",[34,38],"v2"]