NCT06059872 · VA Office of Research and Development
Biomarkers of Reaction To HIIT Exercise
(BReaTHE)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
High Intensity Interval Training (HIIT)
HIIT 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.
Primary outcome measures
10 m walk test on a GAITRite mat
Time frame: baseline (week 1) and after the completion of 12 weeks of exercise (week 14)
To assess short-distance walking speed and gait characteristics.
Timed-Up-and-Go (TUG) test
Time frame: baseline (week 1) and after the completion of 12 weeks of exercise (week 14)
To assess short-distance walking and postural control.
6-minute walk test
Time frame: baseline (week 1) and after the completion of 12 weeks of exercise (week 14)
To assess endurance.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Decatur, Georgia
Collaborators
Atlanta VA Medical Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 27, 2026 · Source of record for eligibility and locations