Neuroplastic Changes Due to an Exercise Intervention That Aid in Lower Limb Recovery After Subcortical Stroke

NCT07663292 | Not Yet Recruiting DMC

• 1 other identifier: 2025P010166
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to develop imaging-based biomarkers to assess which chronic stroke participant with lower extremity disability may respond or resist high intensity interval training (HIIT). Previous research suggests that physical exercise training is safe and could help improve the walking speed of non-ambulatory stroke survivors. However, inter-individual variability in response to exercise is extraordinarily high regardless of adherence, and predictors of response remain elusive. Chronic stroke survivors with lower limb disability resulting in slow walking speeds will participate in 12 weeks of cycling exercise at Emory University under the guidance of a physical exercise instructor, 3 days a week, for 25-60 minutes. During some of the exercise sessions, the investigators will collect blood lactate with a finger prick. Brain scans with an MRI before and after the 12 weeks of exercise will be done; motor function tests that include walking, sitting down, standing up, and turning around will be collected. Participants' memory and thinking will be assessed, and participants will fill out questionnaires about their health before and after their stroke, and well as questions about their diet. The participation will last between 14-16 weeks (up to 42 study visits).

Conditions

Subcortical Lesions; Stroke

Keywords

High intensity interval training

Outcome Measures

Primary Outcomes (1)

• Walking Speed Assessed by the 10-Meter Walk Test (10MWT)

  Walking speed will be measured using the 10-Meter Walk Test (10MWT). Participants will be instructed to walk a measured 10-meter distance at their comfortable walking speed. The time required to traverse the designated distance will be recorded using a stopwatch, and walking speed will be calculated as distance divided by time and expressed in meters per second (m/s). Higher values indicate faster walking speed and improved ambulatory function.

  12 weeks post-intervention

Secondary Outcomes (3)

• Functional Mobility Assessed by the Timed Up and Go Test (TUG)

  12 weeks post-intervention

• Walking Endurance Assessed by the 6-Minute Walk Test (6MWT)

  12 weeks post-intervention

• Change in Resting-State Functional Connectivity of the Cognitive-Motor Network Assessed by MRI

  Baseline, 12 weeks post-intervention

Other Outcomes (1)

• Blood Lactate Levels

  Baseline, 12 weeks post-intervention

Study Arms (1)

HIIT intervention in chronic subcortical stroke participants

EXPERIMENTAL

The HIIT consists of three weekly 25-60 minute cycling sessions for 12 weeks at Emory University, administered by a trained exercise physiologist, for a total of 36 HIIT sessions.

Behavioral: HIIT intervention

Interventions

HIIT intervention BEHAVIORAL

Three weekly 25-60 minute cycling sessions for 12 weeks for a total of 36 HIIT sessions. Each exercise session will start with a 5 minute warm up, followed by 20 minutes or more of moderate to intense cycling. Each session, the time will increase by one minute. The trained exercise physiologist may ask the participant to cruise (cycle at a comfortable pace), sprint (cycle faster), or climb (increase gear) in order to generate intervals of moderate and high intensity exercise during the session. During HIIT sessions 1, 4, 7, 10, and 28 the participant's blood lactate will be measured via finger prick 7 times each session (for a total of 35 finger pricks) to assess if their lactate threshold is surpassed during HIIT. One week before the intervention and one week after, the participant will be asked to take part in an assessment of lower extremity motor function including walking speed, and a 90-minute MRI session for a brain scan.

HIIT intervention in chronic subcortical stroke participants

Eligibility Criteria

• Age: 18 Years - 80 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,
• age 18-80 years old, and
• Screen pass of the Stress test or Physician sign-off from the participant's health care team that they are cleared for a 12 week exercise intervention

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
• visual or auditory impairment that may hinder study procedures, and
• any medical condition that would preclude from participation in a physical exercise intervention program.

Sponsors & Collaborators

• Emory University: lead
• American Heart Association: collaborator

Study Sites (2)

Emory Rehabilitation Hospital

Atlanta, Georgia, 30322, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lisa Krishnamurthy, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Krishnamurthy, PhD

CONTACT

404-712-5332; lkrish2@emory.edu

Susan Murphy

CONTACT

404-712-1928; smurph7@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will become available 6 months after the last participant's data is collected
• Access Criteria: Data will be made available to investigators at research institutions, for secondary analyses, upon written request.

Locations

US (2)