Biomarkers of Reaction To HIIT Exercise

NCT06059872 | Recruiting

• 2 other identifiers: N4537-RI01RX004537
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 10 m walk test on a GAITRite mat

  To assess short-distance walking speed and gait characteristics.

  baseline (week 1) and after the completion of 12 weeks of exercise (week 14)

• Timed-Up-and-Go (TUG) test

  To assess short-distance walking and postural control.

  baseline (week 1) and after the completion of 12 weeks of exercise (week 14)

• 6-minute walk test

  To assess endurance.

  baseline (week 1) and after the completion of 12 weeks of exercise (week 14)

Secondary Outcomes (4)

• Blood lactate change during HIIT session

  On exercise day 1, 4, 7, 10, and 28. The total number of exercise days is 36 (3 times per week for 12 weeks).

• MEGA-PRESS Magnetic Resonance Spectroscopy

  baseline (week 1) and after the completion of 12 weeks of exercise (week 14)

• pseudo Continuous Arterial Spin Labeling MRI

  baseline (week 1) and after the completion of 12 weeks of exercise (week 14)

• Graded treadmill or bike testing

  baseline (week 1) and after the completion of 12 weeks of exercise (week 14)

Other Outcomes (3)

• Repetition max strength test

  baseline (week 1) and after the completion of 12 weeks of exercise (week 14)

• Global physical activity questionnaire (GPAQ)

  baseline (week 1)

• Self-administered Comorbidity Questionnaire (SCQ)

  baseline (week 1) and after the completion of 12 weeks of exercise (week 14)

Study Arms (1)

Chronic Stroke with lower limb disability

EXPERIMENTAL

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.

Other: High Intensity Interval Training (HIIT)

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.

Chronic Stroke with lower limb disability

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Atlanta VA Medical Center: collaborator

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Paraparesis, Spastic; Mobility Limitation

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paraparesis; Paresis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lisa C Krishnamurthy, PhD

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa C Krishnamurthy, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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 overall study protocol with pre-, during-, and post-intervention measurements. The 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 Record Dates

• First Submitted: September 18, 2023
• First Posted: September 29, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Upon close of the study.

Locations

US (1)