Back to resultsHigh Intensity Interval Training in Chronic Stroke (HIT)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-intensity interval training (HIT)
Traditional Aerobic Training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Rehabilitation, Exercise, Intensity, Gait
Eligibility Criteria
Inclusion Criteria:
- 1) age 35-90 years
- 2) unilateral stroke experienced >6 months prior to enrollment
- 3) able to walk 10m overground with assistive devices as needed and no physical assistance
- 4) able to walk 3 minutes on the treadmill at >.13m/s (0.3mph) with no aerobic exercise contraindications
- 5) stable cardiovascular condition (American Heart Association class B, allowing for aerobic capacity <6 metabolic equivalents)
- 6) discharged from formal rehabilitation
Exclusion Criteria:
- 1) significant resting ECG abnormalities
- 2) evidence of significant arrhythmia or myocardial ischemia on treadmill ECG stress test
- 3) hospitalization for cardiac or pulmonary disease within 3 months
- 4) pacemaker or implanted defibrillator
- 5) lower extremity claudication
- 6) unable to communicate with investigators or correctly answer consent comprehension questions
- 7) severe lower extremity spasticity (Ashworth >2)
- 8) lower extremity weight bearing pain >4/10 on visual analogue scale
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.
Sites / Locations
- University of Cincinnati
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High-intensity interval training (HIT)
Traditional aerobic training
Arm Description
Treadmill exercise using bursts of concentrated effort alternated with recovery periods
Moderate intensity continuous aerobic exercise on a treadmill
Outcomes
Primary Outcome Measures
Change in Peak Aerobic Capacity (VO2-peak)
Secondary Outcome Measures
Change in Submaximal Aerobic Capacity (VO2 at Ventilatory Threshold)
Change in Gait Velocity (10 Meter Walk Test)
Change in 6-Minute Walk Test
distance walked in 6 minutes
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
Change in Fastest Treadmill Speed (Steep Ramp Test)
fastest safe treadmill walking speed
Change in Fractional Utilization
Metabolic cost of gait as a percentage of aerobic capacity
Full Information
NCT ID
NCT01958606
First Posted
October 7, 2013
Last Updated
April 8, 2017
Sponsor
University of Cincinnati
Collaborators
American Physical Therapy Association, Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT01958606
Brief Title
High Intensity Interval Training in Chronic Stroke
Acronym
HIT
Official Title
High Intensity Interval Training in Chronic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
American Physical Therapy Association, Children's Hospital Medical Center, Cincinnati
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study was to compare the effectiveness of high intensity interval training (HIT) and traditional aerobic training for persons with stroke.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Rehabilitation, Exercise, Intensity, Gait
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-intensity interval training (HIT)
Arm Type
Experimental
Arm Description
Treadmill exercise using bursts of concentrated effort alternated with recovery periods
Arm Title
Traditional aerobic training
Arm Type
Active Comparator
Arm Description
Moderate intensity continuous aerobic exercise on a treadmill
Intervention Type
Other
Intervention Name(s)
High-intensity interval training (HIT)
Intervention Description
Treadmill exercise using bursts of concentrated effort alternated with recovery periods
Intervention Type
Other
Intervention Name(s)
Traditional Aerobic Training
Intervention Description
Moderate intensity continuous aerobic exercise on a treadmill
Primary Outcome Measure Information:
Title
Change in Peak Aerobic Capacity (VO2-peak)
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Change in Submaximal Aerobic Capacity (VO2 at Ventilatory Threshold)
Time Frame
Baseline and 4 weeks
Title
Change in Gait Velocity (10 Meter Walk Test)
Time Frame
Baseline and 4 weeks
Title
Change in 6-Minute Walk Test
Description
distance walked in 6 minutes
Time Frame
Baseline and 4 weeks
Title
Change in Gait Economy (Mean Oxygen Uptake at Comfortable Walking Speed)
Description
mean oxygen uptake at comfortable walking speed reported in units mLO2 per kilogram body weight per meter
Time Frame
Baseline and 4 weeks
Title
Change in Fastest Treadmill Speed (Steep Ramp Test)
Description
fastest safe treadmill walking speed
Time Frame
Baseline and 4 weeks
Title
Change in Fractional Utilization
Description
Metabolic cost of gait as a percentage of aerobic capacity
Time Frame
Baseline and 4 weeks
Other Pre-specified Outcome Measures:
Title
Change in Self-Efficacy and Outcome Expectations for Exercise Scale
Time Frame
Baseline and 4 weeks
Title
Change in Montreal Cognitive Assessment
Time Frame
Baseline and 4 weeks
Title
Change in Gait Kinematics/Kinetics From Baseline to 4 Weeks
Description
3D motion capture and force plates
Time Frame
Baseline and 4 weeks
Title
Change in Gait Kinematics/Kinetics From Baseline to Post Session 1
Description
3D motion capture and force plates
Time Frame
Baseline and after session 1
Title
Change in Gait Kinematics/Kinetics During Session 1
Description
3D motion capture and force plates
Time Frame
During session 1
Title
Change in Transcranial Magnetic Stimulation (TMS) Responses From Baseline to 4 Weeks
Description
Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency, corticomotor map size and volume and intracortical inhibition
Time Frame
Baseline and 4 weeks
Title
Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 2
Description
Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition
Time Frame
Before and after training session 2
Title
Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 12
Description
Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition
Time Frame
Before and after training session 12
Title
Change in Daily Physical Activity (Activity Monitor)
Time Frame
Baseline and 4 weeks
Title
Change in Stroke Impact Scale
Description
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.
Time Frame
Baseline and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1) age 35-90 years
2) unilateral stroke experienced >6 months prior to enrollment
3) able to walk 10m overground with assistive devices as needed and no physical assistance
4) able to walk 3 minutes on the treadmill at >.13m/s (0.3mph) with no aerobic exercise contraindications
5) stable cardiovascular condition (American Heart Association class B, allowing for aerobic capacity <6 metabolic equivalents)
6) discharged from formal rehabilitation
Exclusion Criteria:
1) significant resting ECG abnormalities
2) evidence of significant arrhythmia or myocardial ischemia on treadmill ECG stress test
3) hospitalization for cardiac or pulmonary disease within 3 months
4) pacemaker or implanted defibrillator
5) lower extremity claudication
6) unable to communicate with investigators or correctly answer consent comprehension questions
7) severe lower extremity spasticity (Ashworth >2)
8) lower extremity weight bearing pain >4/10 on visual analogue scale
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett Kissela, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kari Dunning, PhD, PT
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
12. IPD Sharing Statement
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High Intensity Interval Training in Chronic Stroke
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