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Subjects with stroke will have behavioral testing and brain imaging before and after a 4-week control period and a 4-week exercise intervention.
Subjects with stroke will have behavioral testing and brain imaging before and after a 4-week control period and a 4-week exercise intervention using high-intensity interval training.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 4-week control period with no intervention and 4-weeks of high-intensity interval training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Behavioral | No intervention |
| |
| High-intensity interval training |
| Measure | Description | Time Frame |
|---|---|---|
| Walking Speed | 10-meter walk test | Change from 4-weeks to 8-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Symmetry | Paretic step ratio | baseline, 4 weeks, 8 weeks |
| Metabolic Cost of Gait | oxygen consumption rate during comfortable speed gait |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierce Boyne, PT, DPT, NCS | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42204918 | Derived | Foster J, Awosika OO, Boyne P. Role of Contralesional Corticoreticulospinal Tract Compensation in Walking Function After Stroke. Brain Behav. 2026 Jun;16(6):e71500. doi: 10.1002/brb3.71500. | |
| 42180339 | Derived | Foster J, Awosika OO, Boyne P. Longitudinal changes in the cortico-reticulospinal tract associated with high-intensity locomotor training in chronic stroke. medRxiv [Preprint]. 2026 May 15:2026.05.12.26353042. doi: 10.64898/2026.05.12.26353042. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | 4-week control period with no intervention and 4-weeks of high-intensity interval training No intervention: No intervention High-intensity interval training: High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | 4-week control period with no intervention and 4-weeks of high-intensity interval training No intervention: No intervention High-intensity interval training: High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Walking Speed | 10-meter walk test | Posted | Least Squares Mean | 95% Confidence Interval | meters per second | Change from 4-weeks to 8-weeks |
|
|
Throughout study participation, which lasted approximately 4 months for each participant. The entire study lasted approximately 17 months.
Each study visit, participant voluntary reporting of adverse events (AEs) was encouraged and AEs of interest were specifically queried, including: falls, orthopedic injuries, faintness, new/increased pain and muscle soreness. During clinical testing and training sessions, participants also had monitoring and post-session questioning to identify any signs or symptoms of cardiorespiratory insufficiency, new/worsening neurological impairments or orthopedic injury.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | 4-week control period with no intervention and 4-weeks of high-intensity interval training No intervention: No intervention High-intensity interval training: High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pierce Boyne | University of Cincinnati | 5135587499 | Pierce.Boyne@uc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 24, 2018 | Nov 26, 2018 | Prot_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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Outcomes Assessor was blinded to study design, including when participant was in control phase versus intervention phase
| Behavioral |
High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods |
|
| baseline, 4 weeks, 8 weeks |
| Aerobic Capacity | oxygen consumption rate during exercise testing | baseline, 4 weeks, 8 weeks |
| NIH Toolbox - Cognition Domain | baseline, 4 weeks, 8 weeks |
| NIH Toolbox Standing Balance Test | baseline, 4 weeks, 8 weeks |
| Stroke and Aphasia Quality of Life Scale | baseline, 4 weeks, 8 weeks |
| Brain Locomotor Network Activation | baseline, 4 weeks, 8 weeks |
| Brain Locomotor Network Connectivity | baseline, 4 weeks, 8 weeks |
| Walking Capacity | 6-minute walk test | baseline, 4 weeks, 8 weeks |
| Daily Walking Activity | activity monitor | baseline, 4 weeks, 8 weeks |
| Walking Speed | 10-meter walk test | baseline, 4 weeks, 8 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Comfortable Gait Speed, m/s | Mean | Standard Deviation | meters per second |
|
| Stroke Chronicity | Mean | Standard Deviation | years |
|
|
|
| Secondary | Gait Symmetry | Paretic step ratio | Not Posted | baseline, 4 weeks, 8 weeks | Participants |
| Secondary | Metabolic Cost of Gait | oxygen consumption rate during comfortable speed gait | Not Posted | baseline, 4 weeks, 8 weeks | Participants |
| Secondary | Aerobic Capacity | oxygen consumption rate during exercise testing | Not Posted | baseline, 4 weeks, 8 weeks | Participants |
| Secondary | NIH Toolbox - Cognition Domain | Not Posted | baseline, 4 weeks, 8 weeks | Participants |
| Secondary | NIH Toolbox Standing Balance Test | Not Posted | baseline, 4 weeks, 8 weeks | Participants |
| Secondary | Stroke and Aphasia Quality of Life Scale | Not Posted | baseline, 4 weeks, 8 weeks | Participants |
| Secondary | Brain Locomotor Network Activation | Not Posted | baseline, 4 weeks, 8 weeks | Participants |
| Secondary | Brain Locomotor Network Connectivity | Not Posted | baseline, 4 weeks, 8 weeks | Participants |
| Secondary | Walking Capacity | 6-minute walk test | Not Posted | baseline, 4 weeks, 8 weeks | Participants |
| Secondary | Daily Walking Activity | activity monitor | Not Posted | baseline, 4 weeks, 8 weeks | Participants |
| Secondary | Walking Speed | 10-meter walk test | Not Posted | baseline, 4 weeks, 8 weeks | Participants |
| 0 |
| 10 |
| 0 |
| 10 |
| 8 |
| 10 |
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fatigue | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment | Common cold |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Increased knee hyperextension | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain/soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Surgical procedure | Musculoskeletal and connective tissue disorders | Systematic Assessment | routine excision of ingrown toenail |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |