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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD093694 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| University of Kansas Medical Center | OTHER |
| University of Delaware | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate-Intensity Aerobic Training | Active Comparator |
| |
| High-Intensity Interval Training | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate-Intensity Aerobic Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-Minute Walk Test Distance | Total distance walked in 6 minutes in meters | Change from Baseline to 12 weeks |
| Measure | Description | Time 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Audrey Nicoloff | Contact | 513-558-7487 | strokerecovery@uc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Pierce Boyne, PT, DPT, PhD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Delaware | Recruiting | Newark | Delaware | 19713 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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: 10.64898/2026.04.16.26351040. | |
| 40766122 | Derived | 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: 10.1101/2025.07.30.25332470. |
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The final, de-identified dataset and data documentation will be deposited into the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) archive
Will be submitted within one year of trial completion and will remain available indefinitely
Established by the repository
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 11, 2024 | Jan 7, 2025 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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| High-Intensity Interval Training | Behavioral | 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. |
|
| 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 |
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
|
| University of Cincinnati | Recruiting | Cincinnati | Ohio | 45267 | United States |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |