High Intensity Interval Training in Chronic Stroke (HIT)

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

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: High-intensity interval training (HIT); Other: Traditional Aerobic Training

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Peak Aerobic Capacity (VO2-peak)	Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: Children's Hospital Medical Center, Cincinnati; American Physical Therapy Association
• Investigators: Principal Investigator: Brett Kissela, MD, University of Cincinnati; Principal Investigator: Kari Dunning, PhD, PT, University of Cincinnati

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: October 7, 2013
• First Submitted That Met QC Criteria: October 7, 2013
• First Posted (Estimate): October 9, 2013

Study Record Updates

• Last Update Posted (Actual): May 15, 2017
• Last Update Submitted That Met QC Criteria: April 8, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Rehabilitation; Exercise; Stroke; Gait; Intensity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: HIT in chronic stroke