Biomarkers of Reaction To HIIT Exercise
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorVA Office of Research and Development
About this trial
Stroke survivors with lower limb disability can improve their walking speed with high-intensity interval training (HIIT) rehabilitation therapy. However, some individuals may not respond to HIIT even when fully adherent to the program. To address this, the investigators propose to build a predictive model that identifies if a Veteran with chronic subcortical stroke will improve their walking speed with HIIT by incorporating blood lactate as an early predictor of exercise response, and inhibitory neurotransmitter gamma-aminobutyric acid (GABA) and regional cerebral blood flow (CBF) as predictors of the brain's potential to respond, while also taking into consideration other factors such as comorbidities, demographics, and fitness levels.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
chronic left or right subcortical stroke as defined by 6 months or more after a cardiovascular accident
lower extremity motor impairment due to stroke that causes a walking speed of less than 0.6 m/s during a 10m walk
Veteran status
Disqualifiers
MRI contraindications, including implanted cardiac pacemakers and severe claustrophobia
any neurodegenerative condition other than stroke that may lead to lower extremity impairment
a visual or auditory impairment that may hinder study procedures
any medical condition that would preclude participation in a physical exercise intervention program
Trial design
Design model
Single group
Treatments tested in this trial
High Intensity Interval Training (HIIT)
Other interventionHIIT consists of three weekly 25-60 minute cycling sessions for 12 weeks at the Atlanta VA, administered by a trained exercise physiologist, for a total of 36 HIIT sessions.
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: Chronic Stroke with lower limb disabilityExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
10 m walk test on a GAITRite mat
To assess short-distance walking speed and gait characteristics.
Time frame
baseline (week 1) and after the completion of 12 weeks of exercise (week 14)2
Timed-Up-and-Go (TUG) test
To assess short-distance walking and postural control.
Time frame
baseline (week 1) and after the completion of 12 weeks of exercise (week 14)3
6-minute walk test
To assess endurance.
Time frame
baseline (week 1) and after the completion of 12 weeks of exercise (week 14)Secondary outcomes
1
Blood lactate change during HIIT session
To assess if the participant increases their blood lactate during the HIIT session.
Time frame
On exercise day 1, 4, 7, 10, and 28. The total number of exercise days is 36 (3 times per week for 12 weeks).2
MEGA-PRESS Magnetic Resonance Spectroscopy
To assess GABA from the ipsilesional and contralesional leg areas of the brain.
Time frame
baseline (week 1) and after the completion of 12 weeks of exercise (week 14)3
pseudo Continuous Arterial Spin Labeling MRI
To assess whole brain regional cerebral blood flow.
Time frame
baseline (week 1) and after the completion of 12 weeks of exercise (week 14)4
Graded treadmill or bike testing
To estimate VO2-max.
Time frame
baseline (week 1) and after the completion of 12 weeks of exercise (week 14)Other outcomes
1
Repetition max strength test
To assess the leg strength of the affected and less affected leg.
Time frame
baseline (week 1) and after the completion of 12 weeks of exercise (week 14)2
Global physical activity questionnaire (GPAQ)
To assess pre-stroke fitness levels.
Time frame
baseline (week 1)3
Self-administered Comorbidity Questionnaire (SCQ)
To assess the presence and burden of comorbidities.
Time frame
baseline (week 1) and after the completion of 12 weeks of exercise (week 14)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
VA Office of Research and Development
Lead sponsor
Atlanta VA Medical Center
Collaborator
Source ClinicalTrials.gov