Subcortical LesionsNCT07663292
Neuroplastic Changes Due to an Exercise Intervention That Aid in Lower Limb Recovery After Subcortical Stroke
A study testing HIIT intervention in people with Subcortical Lesions and Stroke, run by Emory University at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Subcortical Lesions, Stroke
- What is being tested?
- HIIT intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Emory Rehabilitation Hospital
Atlanta, Georgia, 30322
Susan Murphy, 404-712-1928, smurph7@emory.edu
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Susan Murphy, 404-712-1928, smurph7@emory.edu
About this study
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.
Read more
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).
Read the detailed description
This study will enroll 55 participants with chronic subcortical stroke in the 12-week HIIT intervention. 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 Emory University, administered by a trained exercise physiologist, for a total of 36 HIIT sessions. To accommodate stroke participants with lower limb disability, the study team will use a wheelchair accessible whole body trainer that uses a cycling motion. 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. The goal is to work the participant in a heart rate reserve (HRR) of 60-90%. The heart rate will constantly be monitored 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. The overall goal of this study is to determine if the investigators can identify neurophysiological and imaging-derived biomarkers to predict whether a chronic subcortical stroke patient with lower extremity disability will respond to a 12-week HIIT intervention. Supported by preliminary data, the study team will build a model to consider the combined effects of blood lactate, baseline GABA, baseline CBF, baseline leg weakness, pre-stroke fitness, baseline VO2-max, age, sex, and comorbidities to predict improvements in walking speed after 12 weeks of HIIT.
- Conditions
- Subcortical Lesions, Stroke
- Being tested
- HIIT intervention
- Keywords
- High intensity interval training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: HIIT intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks post-intervention
Secondary outcomes (3)
Functional Mobility Assessed by the Timed Up and Go Test (TUG)
Functional mobility will be measured using the Timed Up and Go (TUG) test. Participants will be instructed to rise from a standard chair, walk 3 meters at a safe and comfortable pace, turn around, walk back to the chair, and sit down. The time required to complete the task will be recorded using a stopwatch and expressed in seconds (s). Lower completion times indicate better functional mobility and dynamic balance.
Measured: 12 weeks post-intervention
Walking Endurance Assessed by the 6-Minute Walk Test (6MWT)
Walking endurance will be measured using the 6-Minute Walk Test (6MWT). Participants will be instructed to walk as far as possible along a designated walkway for 6 minutes at a self-selected pace, with rest periods permitted as needed according to standardized testing procedures. The total distance walked during the 6-minute period will be recorded and expressed in meters (m). Greater distances indicate better walking endurance and functional exercise capacity.
Measured: 12 weeks post-intervention
Change in Resting-State Functional Connectivity of the Cognitive-Motor Network Assessed by MRI
Brain function will be assessed using resting-state functional magnetic resonance imaging (rsfMRI) acquired before and after the 12-week high-intensity interval training (HIIT) intervention. Functional connectivity will be quantified using echo-planar time-resolved imaging (EPTI) and expressed as z-transformed correlation values.
Measured: Baseline, 12 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subcortical LesionsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Lisa Krishnamurthy, Emory University
- Investigators
- Lisa Krishnamurthy, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663292
- Sponsor's protocol ID
- 2025P010166
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw images and interstitial processed images (including lesion masks), as well as demographic and motor testing data.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroplastic Changes Due to an Exercise Intervention That Aid in Lower Limb Recovery After Subcortical Stroke
- ClinicalTrials.gov ID
- NCT07663292
- Acronym / sponsor ID
- 2025P010166
- Conditions
- Subcortical Lesions, Stroke
- Keywords
- High intensity interval training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This study will enroll 55 participants with chronic subcortical stroke in the 12-week HIIT intervention. 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 Emory University, administered by a trained exercise physiologist, for a total of 36 HIIT sessions. To accommodate stroke participants with lower limb disability, the study team will use a wheelchair accessible whole body trainer that uses a cycling motion. 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. The goal is to work the participant in a heart rate reserve (HRR) of 60-90%. The heart rate will constantly be monitored 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. The overall goal of this study is to determine if the investigators can identify neurophysiological and imaging-derived biomarkers to predict whether a chronic subcortical stroke patient with lower extremity disability will respond to a 12-week HIIT intervention. Supported by preliminary data, the study team will build a model to consider the combined effects of blood lactate, baseline GABA, baseline CBF, baseline leg weakness, pre-stroke fitness, baseline VO2-max, age, sex, and comorbidities to predict improvements in walking speed after 12 weeks of HIIT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIIT intervention in chronic subcortical stroke participants | Experimental | Behavioral: HIIT interventionThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIIT interventionThree 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. | Behavioural | HIIT intervention in chronic subcortical stroke participants |
Primary outcome
Walking Speed Assessed by the 10-Meter Walk Test (10MWT)
Time frame: 12 weeks post-intervention
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.
3 secondary outcomes
Functional Mobility Assessed by the Timed Up and Go Test (TUG)
Time frame: 12 weeks post-intervention
Walking Endurance Assessed by the 6-Minute Walk Test (6MWT)
Time frame: 12 weeks post-intervention
Change in Resting-State Functional Connectivity of the Cognitive-Motor Network Assessed by MRI
Time frame: Baseline, 12 weeks post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Yes. Raw images and interstitial processed images (including lesion masks), as well as demographic and motor testing data.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Krishnamurthy, PhD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT intervention in people with Subcortical Lesions and Stroke, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Krishnamurthy, PhD (404-712-5332, lkrish2@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Speed Assessed by the 10-Meter Walk Test (10MWT) (time frame: 12 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.