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| Name | Class |
|---|---|
| American Physical Therapy Association | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
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The objective of this study was to compare the effectiveness of high intensity interval training (HIT) and traditional aerobic training for persons with stroke.
Participants were randomized to either HIT or traditional aerobic training; each 25 minutes, 3 times per week for 4 weeks. Outcomes were measured before and after training by a blinded rater.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-intensity interval training (HIT) | Experimental | Treadmill exercise using bursts of concentrated effort alternated with recovery periods |
|
| Traditional aerobic training | Active Comparator | Moderate intensity continuous aerobic exercise on a treadmill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-intensity interval training (HIT) | Other | Treadmill exercise using bursts of concentrated effort alternated with recovery periods |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak Aerobic Capacity (VO2-peak) | Baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Submaximal Aerobic Capacity (VO2 at Ventilatory Threshold) | Baseline and 4 weeks | |
| Change in Gait Velocity (10 Meter Walk Test) | Baseline and 4 weeks | |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-Efficacy and Outcome Expectations for Exercise Scale | Baseline and 4 weeks | |
| Change in Montreal Cognitive Assessment | Baseline and 4 weeks | |
| Change in Gait Kinematics/Kinetics From Baseline to 4 Weeks |
Inclusion Criteria:
Exclusion Criteria:
For the transcranial magnetic stimulation substudy, additional exclusions will also be applied. These include large cerebral infarcts or other structural defects with the potential to increase seizure risk, uncontrolled seizures, metal implants and previous craniotomy.
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| Name | Affiliation | Role |
|---|---|---|
| Brett Kissela, MD | University of Cincinnati | Principal Investigator |
| Kari Dunning, PhD, PT | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | High-intensity Interval Training (HIT) | Treadmill exercise using bursts of concentrated effort alternated with recovery periods High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods |
| FG001 | Traditional Aerobic Training | Moderate intensity continuous aerobic exercise on a treadmill Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High-intensity Interval Training (HIT) | Treadmill exercise using bursts of concentrated effort alternated with recovery periods High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods |
| BG001 | Traditional Aerobic Training |
| 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 | Change in Peak Aerobic Capacity (VO2-peak) | on treatment analysis | Posted | Least Squares Mean | 95% Confidence Interval | ml/kg/min | Baseline and 4 weeks |
|
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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 | High-intensity Interval Training (HIT) | Treadmill exercise using bursts of concentrated effort alternated with recovery periods High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Joint/muscle soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pierce Boyne | University of Cincinnati | 513-558-7499 | Pierce.Boyne@uc.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009043 | Motor Activity |
| 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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| Traditional Aerobic Training | Other | Moderate intensity continuous aerobic exercise on a treadmill |
|
| Change in 6-Minute Walk Test |
distance walked in 6 minutes |
| Baseline and 4 weeks |
| Change in Gait Economy (Mean Oxygen Uptake at Comfortable Walking Speed) | mean oxygen uptake at comfortable walking speed reported in units mLO2 per kilogram body weight per meter | Baseline and 4 weeks |
| Change in Fastest Treadmill Speed (Steep Ramp Test) | fastest safe treadmill walking speed | Baseline and 4 weeks |
| Change in Fractional Utilization | Metabolic cost of gait as a percentage of aerobic capacity | Baseline and 4 weeks |
3D motion capture and force plates |
| Baseline and 4 weeks |
| Change in Gait Kinematics/Kinetics From Baseline to Post Session 1 | 3D motion capture and force plates | Baseline and after session 1 |
| Change in Gait Kinematics/Kinetics During Session 1 | 3D motion capture and force plates | During session 1 |
| Change in Transcranial Magnetic Stimulation (TMS) Responses From Baseline to 4 Weeks | Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency, corticomotor map size and volume and intracortical inhibition | Baseline and 4 weeks |
| Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 2 | Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition | Before and after training session 2 |
| Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 12 | Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition | Before and after training session 12 |
| Change in Daily Physical Activity (Activity Monitor) | Baseline and 4 weeks |
| Change in Stroke Impact Scale | Cognition Domain Score of Stroke Impact Scale. Scores range from 0 to 100 (higher is better) and represent a sum of scores from multiple questions related to cognition. | Baseline and 4 weeks |
Moderate intensity continuous aerobic exercise on a treadmill Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Comfortable gait speed, m/s | Mean | Standard Deviation | m/s |
|
| Peak oxygen consumption rate, ml/kg/min | Mean | Standard Deviation | ml/kg/min |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change in Submaximal Aerobic Capacity (VO2 at Ventilatory Threshold) | ventilatory threshold was not identifiable for one participant | Posted | Least Squares Mean | 95% Confidence Interval | ml/kg/min | Baseline and 4 weeks |
|
|
|
| Secondary | Change in Gait Velocity (10 Meter Walk Test) | Posted | Least Squares Mean | 95% Confidence Interval | m/s | Baseline and 4 weeks |
|
|
|
| Secondary | Change in 6-Minute Walk Test | distance walked in 6 minutes | Posted | Mean | 95% Confidence Interval | meters | Baseline and 4 weeks |
|
|
|
| Secondary | Change in Gait Economy (Mean Oxygen Uptake at Comfortable Walking Speed) | mean oxygen uptake at comfortable walking speed reported in units mLO2 per kilogram body weight per meter | Subjects with available data | Posted | Mean | 95% Confidence Interval | mLO2/kg/m | Baseline and 4 weeks |
|
|
|
| Secondary | Change in Fastest Treadmill Speed (Steep Ramp Test) | fastest safe treadmill walking speed | Posted | Mean | 95% Confidence Interval | meters per second | Baseline and 4 weeks |
|
|
|
| Secondary | Change in Fractional Utilization | Metabolic cost of gait as a percentage of aerobic capacity | Subjects with available data | Posted | Mean | 95% Confidence Interval | percentage of aerobic capacity | Baseline and 4 weeks |
|
|
|
| Other Pre-specified | Change in Self-Efficacy and Outcome Expectations for Exercise Scale | Outcome measure not used | Posted | Baseline and 4 weeks |
|
|
| Other Pre-specified | Change in Montreal Cognitive Assessment | Measure not used | Posted | Baseline and 4 weeks |
|
|
| Other Pre-specified | Change in Gait Kinematics/Kinetics From Baseline to 4 Weeks | 3D motion capture and force plates | Measure not used | Posted | Baseline and 4 weeks |
|
|
| Other Pre-specified | Change in Gait Kinematics/Kinetics From Baseline to Post Session 1 | 3D motion capture and force plates | measure not used | Posted | Baseline and after session 1 |
|
|
| Other Pre-specified | Change in Gait Kinematics/Kinetics During Session 1 | 3D motion capture and force plates | measure not used | Posted | During session 1 |
|
|
| Other Pre-specified | Change in Transcranial Magnetic Stimulation (TMS) Responses From Baseline to 4 Weeks | Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency, corticomotor map size and volume and intracortical inhibition | measure not used | Posted | Baseline and 4 weeks |
|
|
| Other Pre-specified | Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 2 | Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition | measure not used | Posted | Before and after training session 2 |
|
|
| Other Pre-specified | Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 12 | Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition | measure not used | Posted | Before and after training session 12 |
|
|
| Other Pre-specified | Change in Daily Physical Activity (Activity Monitor) | measure not used | Posted | Baseline and 4 weeks |
|
|
| Other Pre-specified | Change in Stroke Impact Scale | Cognition Domain Score of Stroke Impact Scale. Scores range from 0 to 100 (higher is better) and represent a sum of scores from multiple questions related to cognition. | Posted | Mean | Standard Deviation | units on a scale from 0-100 | Baseline and 4 weeks |
|
|
|
| 0 |
| 13 |
| 9 |
| 13 |
| EG001 | Traditional Aerobic Training | Moderate intensity continuous aerobic exercise on a treadmill Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill | 0 | 5 | 4 | 5 |
| Fatigue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Light-headedness | Vascular disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Other injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |