Biomarkers of Reaction To HIIT Exercise

Part of paid clinical trials in Decatur, Georgia.

Sponsor
VA Office of Research and Development
Study ID
NCT06059872
Status
Recruiting

Conditions

  • Lower Extremity Weakness, Spastic
  • Stroke
  • Stroke Rehabilitation
  • Walking, Difficulty

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • High Intensity Interval Training (HIIT) — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jan 1, 2024
Status verified
Mar 2026
Primary completion
Jun 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
55 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atlanta VA Medical and Rehab Center, Decatur, GADecaturGeorgia30033-4004
Lisa C Krishnamurthy, PhD
404-321-6111
Lisa C Krishnamurthy, PhD (PRINCIPAL_INVESTIGATOR)

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