Recruiting

HIIT Exercise

Sponsor:

VA Office of Research and Development

Code:

NCT06059872

Conditions

Stroke

Stroke Rehabilitation

Lower Extremity Weakness, Spastic

Walking, Difficulty

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

High Intensity Interval Training (HIIT)

Study Details

Brief summary:

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.

Conditions

Stroke

Stroke Rehabilitation

Lower Extremity Weakness, Spastic

Walking, Difficulty

Study ID

NCT06059872

Start date

Jan 1, 2024

Status verified date

Mar, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

55 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Chronic Stroke with lower limb disability

The investigators will enroll 55 Veterans with chronic subcortical stroke in the 12-week HIIT intervention, with the expectation that 48 participants (85%) will complete the entire program. In our experience, 65% of participants will respond to the HIIT intervention, resulting in an estimated 31 responders and 17 resistors. Each chronic subcortical stroke participant will be asked to participate in the HIIT study protocol. Classification of resistor or responder: A responder to the 12-week HIIT intervention will be defined as a participant who increases their walking speed to greater than 0.6 m/s. A resistor to the intervention will be defined as a participant who does not increase their walking speed to greater than 0.6 m/s.

Interventions

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 measure

  • 10 m walk test on a GAITRite mat [ Time Frame: baseline (week 1) and after the completion of 12 weeks of exercise (week 14) ]
  • Timed-Up-and-Go (TUG) test [ Time Frame: baseline (week 1) and after the completion of 12 weeks of exercise (week 14) ]
  • 6-minute walk test [ Time Frame: baseline (week 1) and after the completion of 12 weeks of exercise (week 14) ]

Central Contacts and Locations

Central contacts

Lisa C Krishnamurthy, PhD

(404) 321-6111Lisa.Krishnamurthy@va.gov

Locations

Atlanta VA Medical and Rehab Center, Decatur, GA

Recruiting

Decatur, Georgia, United States, 30033-4004

Contacts

Lisa C Krishnamurthy, PhD

404-321-6111Lisa.Krishnamurthy@va.gov

Principal Investigator:

Lisa C Krishnamurthy, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • Predictors of Stroke Rehabilitation
  • Biomarkers of Stroke Rehabilitation
  • Exercise Intervention
  • Neuroimaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-03-27.