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

2026년 8월 18일 업데이트: Lisa Krishnamurthy, Emory University

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).

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

55

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

  • 이름: Lisa Krishnamurthy, PhD
  • 전화번호: 404-712-5332
  • 이메일: lkrish2@emory.edu

연구 장소

  • 미국
    • Georgia
      • Atlanta, Georgia, 미국, 30322
        • 모병
        • Emory Rehabilitation Hospital
        • 연락하다:
      • Atlanta, Georgia, 미국, 30322
        • 모병
        • Emory University Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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,
  • 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

Exclusion Criteria:

  • 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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: HIIT intervention in chronic subcortical stroke participants
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.
행동: HIIT intervention

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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Walking Speed Assessed by the 10-Meter Walk Test (10MWT)
기간: 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.
12 weeks post-intervention

2차 결과 측정

결과 측정
측정값 설명
기간
Functional Mobility Assessed by the Timed Up and Go Test (TUG)
기간: 12 weeks post-intervention
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.
12 weeks post-intervention
Walking Endurance Assessed by the 6-Minute Walk Test (6MWT)
기간: 12 weeks post-intervention
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.
12 weeks post-intervention
Change in Resting-State Functional Connectivity of the Cognitive-Motor Network Assessed by MRI
기간: Baseline, 12 weeks post-intervention
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.
Baseline, 12 weeks post-intervention

기타 결과 측정

결과 측정
측정값 설명
기간
Blood Lactate Levels
기간: Baseline, 12 weeks post-intervention
Blood lactate levels in Millimoles per liter (mmol/L) will be measured at baseline and post-intervention.
Baseline, 12 weeks post-intervention

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Emory University

협력자

American Heart Association

수사관

  • 수석 연구원: Lisa Krishnamurthy, PhD, Emory University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 3월 1일

연구 완료 (추정된)

2027년 3월 1일

연구 등록 날짜

최초 제출

2026년 6월 17일

QC 기준을 충족하는 최초 제출

2026년 6월 17일

처음 게시됨 (실제)

2026년 6월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 18일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2025P010166

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Raw images and interstitial processed images (including lesion masks), as well as demographic and motor testing data.

IPD 공유 기간

The data will become available 6 months after the last participant's data is collected

IPD 공유 액세스 기준

Data will be made available to investigators at research institutions, for secondary analyses, upon written request.

IPD 공유 지원 정보 유형

  • 연구_프로토콜

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다