Clinical trial NCT01958606: High Intensity Interval Training in Chronic Stroke
Official title: High Intensity Interval Training in Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Rehabilitation
Exercise
Intensity
Gait
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: American Physical Therapy Association
name: Children's Hospital Medical Center, Cincinnati
First posted: 2013-10-09
Enrollment: 18
Sex: ALL
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Peak Aerobic Capacity (VO2-peak)
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change in Submaximal Aerobic Capacity (VO2 at Ventilatory Threshold)
timeFrame: Baseline and 4 weeks
measure: Change in Gait Velocity (10 Meter Walk Test)
timeFrame: Baseline and 4 weeks
measure: Change in 6-Minute Walk Test
timeFrame: Baseline and 4 weeks
measure: Change in Gait Economy (Mean Oxygen Uptake at Comfortable Walking Speed)
timeFrame: Baseline and 4 weeks
measure: Change in Fastest Treadmill Speed (Steep Ramp Test)
timeFrame: Baseline and 4 weeks
measure: Change in Fractional Utilization
timeFrame: Baseline and 4 weeks
Other outcomes:
measure: Change in Self-Efficacy and Outcome Expectations for Exercise Scale
timeFrame: Baseline and 4 weeks
measure: Change in Montreal Cognitive Assessment
timeFrame: Baseline and 4 weeks
measure: Change in Gait Kinematics/Kinetics From Baseline to 4 Weeks
timeFrame: Baseline and 4 weeks
measure: Change in Gait Kinematics/Kinetics From Baseline to Post Session 1
timeFrame: Baseline and after session 1
measure: Change in Gait Kinematics/Kinetics During Session 1
timeFrame: During session 1
measure: Change in Transcranial Magnetic Stimulation (TMS) Responses From Baseline to 4 Weeks
timeFrame: Baseline and 4 weeks
measure: Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 2
timeFrame: Before and after training session 2
measure: Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 12
timeFrame: Before and after training session 12
measure: Change in Daily Physical Activity (Activity Monitor)
timeFrame: Baseline and 4 weeks
measure: Change in Stroke Impact Scale
timeFrame: Baseline and 4 weeks
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Brett Kissela, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati
name: Kari Dunning, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: