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Completed

NCT Number: NCT01958606

High Intensity Interval Training in Chronic Stroke

The objective of this study was to compare the effectiveness of high intensity interval training (HIT) and traditional aerobic training for persons with stroke.

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Key information

Age range

35 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-intensity interval training (HIT)

Other

Treadmill exercise using bursts of concentrated effort alternated with recovery periods

Traditional Aerobic Training

Other

Moderate intensity continuous aerobic exercise on a treadmill

Primary outcomes

  1. Change in Peak Aerobic Capacity (VO2-peak)

    Time frame: Baseline and 4 weeks

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • American Physical Therapy Association
  • Children's Hospital Medical Center, Cincinnati

Registry information

Acronym: HIT

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 9, 2013
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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