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

18 de agosto de 2026 actualizado por: 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).

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

55

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Susan Murphy
  • Número de teléfono: 404-712-1928
  • Correo electrónico: smurph7@emory.edu

Copia de seguridad de contactos de estudio

  • Nombre: Lisa Krishnamurthy, PhD
  • Número de teléfono: 404-712-5332
  • Correo electrónico: lkrish2@emory.edu

Ubicaciones de estudio

  • Estados Unidos
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Reclutamiento
        • Emory Rehabilitation Hospital
        • Contacto:
          • Susan Murphy
          • Número de teléfono: 404-712-1928
          • Correo electrónico: smurph7@emory.edu
      • Atlanta, Georgia, Estados Unidos, 30322
        • Reclutamiento
        • Emory University Hospital
        • Contacto:
          • Susan Murphy
          • Número de teléfono: 404-712-1928
          • Correo electrónico: smurph7@emory.edu

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Conductual: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Walking Speed Assessed by the 10-Meter Walk Test (10MWT)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Functional Mobility Assessed by the Timed Up and Go Test (TUG)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Blood Lactate Levels
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Emory University

Colaboradores

American Heart Association

Investigadores

  • Investigador principal: Lisa Krishnamurthy, PhD, Emory University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de marzo de 2027

Finalización del estudio (Estimado)

1 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

17 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de junio de 2026

Publicado por primera vez (Actual)

23 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

18 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2025P010166

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Marco de tiempo para compartir IPD

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

Criterios de acceso compartido de IPD

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

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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