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High Intensity Interval Training in Chronic Stroke (HIT)

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ClinicalTrials.gov Identifier: NCT01958606
Recruitment Status : Completed
First Posted : October 9, 2013
Results First Posted : March 29, 2017
Last Update Posted : May 15, 2017
Sponsor:
Collaborators:
American Physical Therapy Association
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Brett Kissela, University of Cincinnati

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.

Condition or disease Intervention/treatment Phase
Stroke Other: High-intensity interval training (HIT) Other: Traditional Aerobic Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High Intensity Interval Training in Chronic Stroke
Study Start Date : October 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Experimental: High-intensity interval training (HIT)
Treadmill exercise using bursts of concentrated effort alternated with recovery periods
Other: High-intensity interval training (HIT)
Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Active Comparator: Traditional aerobic training
Moderate intensity continuous aerobic exercise on a treadmill
Other: Traditional Aerobic Training
Moderate intensity continuous aerobic exercise on a treadmill




Primary Outcome Measures :
  1. Change in Peak Aerobic Capacity (VO2-peak) [ Time Frame: Baseline and 4 weeks ]

Secondary Outcome Measures :
  1. Change in Submaximal Aerobic Capacity (VO2 at Ventilatory Threshold) [ Time Frame: Baseline and 4 weeks ]
  2. Change in Gait Velocity (10 Meter Walk Test) [ Time Frame: Baseline and 4 weeks ]
  3. Change in 6-Minute Walk Test [ Time Frame: Baseline and 4 weeks ]
    distance walked in 6 minutes

  4. Change in Gait Economy (Mean Oxygen Uptake at Comfortable Walking Speed) [ Time Frame: Baseline and 4 weeks ]
    mean oxygen uptake at comfortable walking speed reported in units mLO2 per kilogram body weight per meter

  5. Change in Fastest Treadmill Speed (Steep Ramp Test) [ Time Frame: Baseline and 4 weeks ]
    fastest safe treadmill walking speed

  6. Change in Fractional Utilization [ Time Frame: Baseline and 4 weeks ]
    Metabolic cost of gait as a percentage of aerobic capacity


Other Outcome Measures:
  1. Change in Self-Efficacy and Outcome Expectations for Exercise Scale [ Time Frame: Baseline and 4 weeks ]
  2. Change in Montreal Cognitive Assessment [ Time Frame: Baseline and 4 weeks ]
  3. Change in Gait Kinematics/Kinetics From Baseline to 4 Weeks [ Time Frame: Baseline and 4 weeks ]
    3D motion capture and force plates

  4. Change in Gait Kinematics/Kinetics From Baseline to Post Session 1 [ Time Frame: Baseline and after session 1 ]
    3D motion capture and force plates

  5. Change in Gait Kinematics/Kinetics During Session 1 [ Time Frame: During session 1 ]
    3D motion capture and force plates

  6. Change in Transcranial Magnetic Stimulation (TMS) Responses From Baseline to 4 Weeks [ Time Frame: Baseline and 4 weeks ]
    Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency, corticomotor map size and volume and intracortical inhibition

  7. Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 2 [ Time Frame: Before and after training session 2 ]
    Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition

  8. Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 12 [ Time Frame: Before and after training session 12 ]
    Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition

  9. Change in Daily Physical Activity (Activity Monitor) [ Time Frame: Baseline and 4 weeks ]
  10. Change in Stroke Impact Scale [ Time Frame: Baseline and 4 weeks ]
    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.



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Ages Eligible for Study:   35 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01958606


Locations
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United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
American Physical Therapy Association
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Brett Kissela, MD University of Cincinnati
Principal Investigator: Kari Dunning, PhD, PT University of Cincinnati

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Responsible Party: Brett Kissela, Principal Investigator, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01958606     History of Changes
Other Study ID Numbers: HIT in chronic stroke
First Posted: October 9, 2013    Key Record Dates
Results First Posted: March 29, 2017
Last Update Posted: May 15, 2017
Last Verified: April 2017

Keywords provided by Brett Kissela, University of Cincinnati:
Stroke
Rehabilitation
Exercise
Intensity
Gait

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases