HIT-Stroke Trial 2
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-85
SponsorUniversity of Cincinnati
About this trial
People who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. Measures including walking function will be assessed at baseline (PRE), after 4, 8 and 12 weeks of training (12WK) and at 3-month follow up (3moPOST), by raters who are unaware of the participant randomization.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 30-85 years at time of consenting
Hemiparesis from ischemic and/or hemorrhagic strokes
Most recent stroke for which participant sought treatment, at least 6 months prior to study consent
Walking speed <1.0 m/s on the 10-meter walk test
Disqualifiers
Exercise testing uninterpretable for ischemia or arrhythmia (e.g. resting ECG abnormality that makes exercise ECG uninterpretable for ischemia and no other clinical testing from the past year available to rule out these conditions)
Evidence of significant arrhythmia or myocardial ischemia on treadmill ECG graded exercise test in the absence of recent (past year) more definitive clinical testing (e.g. stress nuclear imaging) with negative result
Hospitalization for cardiac or pulmonary disease within past 3 months
Implanted pacemaker or defibrillator with an upper heart rate limit that would interfere with exercise testing or prescription, or with unknown limit
Trial design
Design model
Parallel
Treatments tested in this trial
Moderate-Intensity Aerobic Training
BehavioralOverground and treadmill walking with speed continuously adjusted to maintain a target heart rate of 40 +/- 5% heart rate reserve, progressing up to 55 +/- 5% heart rate reserve.
High-Intensity Interval Training
BehavioralOverground and treadmill walking with 30 second bursts at maximum speed alternated with 30-60 second passive recovery periods. Intended to achieve a target average heart rate above 60% heart rate reserve.
Treatment groups
156 Participants
are divided into 2 treatment groupsGroup A: Moderate-Intensity Aerobic TrainingActive comparator 1 intervention
Group B: High-Intensity Interval TrainingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
6-Minute Walk Test Distance
Total distance walked in 6 minutes in meters
Time frame
Change from Baseline to 12 weeksSecondary outcomes
1
6-Minute Walk Test Distance
Total distance walked in 6 minutes in meters
Time frame
Change from Baseline to 3 month follow up2
Self-Selected Gait Speed
From 10-meter walk test at self-selected speed, in meters per second
Time frame
Change from Baseline to 12 weeks3
Fastest Gait Speed
From 10-meter walk test at fastest speed, in meters per second
Time frame
Change from Baseline to 12 weeks4
PROMIS-Fatigue Scale version 8a
An 8-item self-report questionnaire about symptoms of fatigue. Each item is rated from 1-5. Items are combined to obtain a total T score, where higher scores indicate greater fatigue.
Time frame
Change from Baseline to 3 month follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Cincinnati
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
University of Kansas Medical Center
Collaborator
University of Delaware
Collaborator
Source ClinicalTrials.gov