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Ejercicio aeróbico para la remielinización en la esclerosis múltiple

27 de agosto de 2026 actualizado por: Lindsey Wooliscroft, Oregon Health and Science University

Ejercicio aeróbico para mejorar la movilidad en la esclerosis múltiple: optimización del diseño y la ejecución de un ensayo clínico de remielinización multimodal a gran escala

This is a clinical trial to determine the feasibility of a stationary aerobic cycling intervention and explore if aerobic exercise independently promotes remyelination in people with multiple sclerosis (MS).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Multiple sclerosis (MS) is the most common non-traumatic disabling neurologic condition of young adulthood, affecting more than 2.5 million people worldwide. Permanent disability in MS is caused by recurrent demyelination due to episodic inflammation, followed by neuronal damage, axonal degeneration, and progressive failure of remyelination. There is an urgent need to restore activity and participation in people with MS (pwMS), and remyelination is the most promising therapeutic strategy to accomplish this goal.

Remyelination in pwMS will likely require integration of pharmacologic and rehabilitative approaches to ensure effective remyelination of appropriate neural pathways. Aerobic exercise is an ideal complement to remyelinating medications because aerobic exercise 1) improves walking function in pwMS, and 2) promotes remyelination in animal models both independently and synergistically with medications. However, there are many unknowns that need to be addressed before aerobic exercise can be explored in multimodal clinical trials for remyelination. First, it is imperative to understand how myelination impacts disability in MS, as many other factors could contribute to reduced activity and participation. Additionally, as remyelination occurs over 12 to 24 weeks, it is imperative to establish the feasibility of similar duration of aerobic exercise interventions, and explore if exercise independently influences established remyelination outcomes before integration into multimodal strategies.

This is a randomized, single-blind, parallel clinical trial of a 24-week aerobic stationary cycling intervention to determine feasibility and explore if aerobic exercise independently promotes remyelination in pwMS.

Tipo de estudio

Intervencionista

Inscripción (Actual)

60

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.

Ubicaciones de estudio

    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
        • Oregon Health & Science University

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

18 años a 64 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Physician-confirmed diagnosis of MS based on the 2017 McDonald criteria
  • 18-64 years old
  • Have access to the internet and a device that can access virtual visits
  • (Inclusion criteria to advance to clinical trial) Somatosensory evoked potential (SSEP) latency z-score ≥2 for P40 or inter-side difference in z-score ≥2 for P40

Exclusion Criteria:

  • Medical or biophysical conditions that prohibit the use of a cycle ergometer or treadmill (medical readiness to be assessed by the Activity Readiness Questionnaire (PAR-Q)) or achievement of target heart rate.
  • Engages in >30 minutes/week of aerobic activity regularly.
  • Clinically confirmed MS relapse in the last 3 months.
  • Changes in disease modifying therapy (DMT) for MS in the last 6 months.
  • Pregnant women.
  • Treatment with steroids for MS in the last 30 days.
  • Concurrent use of 4-aminopyridine or dalfampridine (medications which can alter SSEP) and unwilling to discontinue it for 2 days prior to SSEP testing.
  • Have a known history of severe spinal canal stenosis

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: MS: Cycle

Twenty-two participants in the clinical trial arm will be randomized to MS:Cycle: an aerobic exercise intervention on a stationary ergometer. Participants will exercise thrice weekly for 30 minutes with graded supervision for 24 weeks.

Aerobic exercise performed on a stationary ergometer for 30 minutes, thrice weekly, with graded supervision. Participants will participate in the intervention over 24 weeks.

Comparador activo: MS: Take Control

Twenty-two participants in the clinical trial arm will be randomized to MS: Take Control (MSTC): a monthly, hour-long MS education control group led by a trained facilitator.

A monthly, hour-long, class over various MS topics and symptoms, led by a trained facilitator.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Somatosensory Evoked Potentials
Periodo de tiempo: From baseline to week 24

Somatosensory evoked potentials (SSEPs) are a measure of functional myelination of the somatosensory tracts (i.e., the time it takes for a sensory signal to travel from the limb to the cortex of the brain). Z-scores were calculated for each leg, adjusting for participant height. A Z-score measures how many standard deviations a specific data point is from the average (mean) of a dataset (where a Z-score of 0 represents the population mean). Averaged Z-scores of the cortical latencies of both legs (i.e., P40) were compared between baseline and week 24 (post-intervention). Z-scores increase with myelin damage in multiple sclerosis (MS). Those with an average Z-score of ≥2 were considered abnormal.

From baseline to week 24

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
6-Minute Timed Walk (6MTW)
Periodo de tiempo: From baseline to week 24

An assessment of exercise tolerance

From baseline to week 24
Timed Up and Go (TUG)
Periodo de tiempo: From baseline to week 24

A test of walking agility

From baseline to week 24
Timed 25-Foot Walk (T25FW)
Periodo de tiempo: From baseline to week 24

A test of walking speed

From baseline to week 24
9 Hole Peg Test
Periodo de tiempo: From baseline to week 24

A test of upper extremity and arm function. Average of both upper extremity times in seconds.

From baseline to week 24
Multiple Sclerosis Functional Composite (MSFC)
Periodo de tiempo: From baseline to week 24

The Multiple Sclerosis Functional Composite (MSFC) is an average of the Z-scores for three individual tests measuring walking speed, upper extremity function and cognition. A Z-score measures how many standard deviations a specific data point is from the average (mean) of a dataset (where a Z-score of 0 represents the population mean). Higher MSFC scores reflect increased multiple sclerosis disability.

From baseline to week 24
Virtual Aerobic Exercise Intervention Adherence
Periodo de tiempo: From baseline to week 24

Defined as participation in at least 80% of the exercise sessions in the trial

From baseline to week 24
Virtual Education Control Group Adherence
Periodo de tiempo: From baseline to week 24

Defined as participation in at least 80% of the education group sessions in the trial

From baseline to week 24
Average Minutes Spent at Goal Heart Rate (HR) During Exercise
Periodo de tiempo: From baseline to week 24

Average number of minutes per session that MS: Cycle participants spent in their goal HR zone (>=70% HR max) during exercise sessions.

From baseline to week 24
Brain Myelin Water Fraction (MWF)
Periodo de tiempo: From baseline to week 24

MWF imaging of the corpus callosum, internal capsule, thalamus, and frontal white matter.

From baseline to week 24
Symbol Digit Modalities Test (SDMT)
Periodo de tiempo: From baseline to week 24

The Symbol Digit Modalities Test (SDMT) is a test of cognitive function. The score reflects how many correct number-symbol pairings an individual can complete in 90 seconds. Higher scores represent better cognitive processing speed and executive function. Scores can range to 0 (i.e., no correct number-symbol pairings) to a theoretically infinite score.

From baseline to week 24
VO2 Max
Periodo de tiempo: From baseline to week 24

A test of aerobic fitness

From baseline to week 24
Modified Fatigue Impact Scale (MFIS)
Periodo de tiempo: From baseline to week 24

A patient reported outcome of fatigue severity with a range of 0-84 (higher scores indicate more fatigue).

From baseline to week 24
Quality of Life in Neurological Disorders (Neuro-QoL)
Periodo de tiempo: From baseline to weeks 24

Quality of Life in Neurological Disorders (Neuro-QoL) questionnaires are patient-reported outcomes of upper and lower extremity function, depression, sleep, and self efficacy. The scores are based on T-scores which is a standardized score with a set mean of 50 and a standard deviation of 10. This scale is used to convert raw data into positive, comparable scores (e.g., T = z × 10 + 50). Increased symptom severity is reflected by lower Neuro-QoL Upper Extremity Function scores, lower Neuro-QoL Lower Extremity Function scores, higher Neuro-QoL Depression scores, higher Neuro-QoL Sleep scores, and lower Self Efficacy scores.

From baseline to weeks 24
International Physical Activity Questionnaire Short Form (IPAQ-SF)
Periodo de tiempo: From baseline to week 24

A patient reported outcome of physical activity reported as the calculated average Metabolic Equivalent of Task (MET) units per week.

From baseline to week 24

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
6-Minute Timed Walk (6MTW)
Periodo de tiempo: From baseline to week 12

An assessment of exercise tolerance

From baseline to week 12
Timed Up and Go (TUG)
Periodo de tiempo: From baseline to week 12

A test of walking agility

From baseline to week 12
Timed 25-Foot Walk (T25FW)
Periodo de tiempo: From baseline to week 12

A test of walking speed

From baseline to week 12
9 Hole Peg Test
Periodo de tiempo: From baseline to week 12

A test of upper extremity and arm function. Average of times for both upper extremities.

From baseline to week 12
Multiple Sclerosis Functional Composite (MSFC)
Periodo de tiempo: From baseline to week 12

The Multiple Sclerosis Functional Composite (MSFC) is an average of the Z-scores for three individual tests measuring walking speed, upper extremity function and cognition. A Z-score measures how many standard deviations a specific data point is from the average (mean) of a dataset (where a Z-score of 0 represents the population mean). Higher MSFC scores reflect increased multiple sclerosis disability.

From baseline to week 12
Symbol Digit Modalities Test (SDMT)
Periodo de tiempo: From baseline to week 12

The Symbol Digit Modalities Test (SDMT) test of cognitive function. The score reflects how many correct number-symbol pairings an individual can complete in 90 seconds. Higher scores represent better cognitive processing speed and executive function. Scores can range to 0 (i.e., no correct number-symbol pairings) to a theoretically infinite score.

From baseline to week 12
Modified Fatigue Impact Scale (MFIS)
Periodo de tiempo: From baseline to week 12

A patient reported outcome of fatigue severity with a range of 0-84 (higher scores indicate more fatigue).

From baseline to week 12
Somatosensory Evoked Potentials (SSEPs)
Periodo de tiempo: From baseline to week 12

Somatosensory evoked potentials (SSEPs) are a measure of functional myelination of the somatosensory tracts (i.e., the time it takes for a sensory signal to travel from the limb to the cortex). Z-scores were calculated for each leg, adjusting for participant height. A Z-score measures how many standard deviations a specific data point is from the average (mean) of a dataset (where a Z-score of 0 represents the population mean). Averaged z-scores of the cortical latencies of both legs (i.e., P40) were compared between baseline and week 12 (post-intervention). Z-scores increase with myelin damage in multiple sclerosis. Those with an average Z-score of ≥2 were considered abnormal.

From baseline to week 12
Quality of Life in Neurological Disorders (Neuro-QoL)
Periodo de tiempo: From baseline to weeks 12

Quality of Life in Neurological Disorders (Neuro-QoL) questionnaires are patient-reported outcomes of upper and lower extremity function, depression, sleep, and self efficacy. The scores are based on T-scores which is a standardized score with a set mean of 50 and a standard deviation of 10. This scale is used to convert raw data into positive, comparable scores (e.g., T = z × 10 + 50). Increased symptom severity is reflected by lower Neuro-QoL Upper Extremity Function scores, lower Neuro-QoL Lower Extremity Function scores, higher Neuro-QoL Depression scores, higher Neuro-QoL Sleep scores, and lower self efficacy scores.

From baseline to weeks 12
International Physical Activity Questionnaire Short Form (IPAQ-SF)
Periodo de tiempo: From baseline to week 12

A patient reported outcome of physical activity reported as the calculated average Metabolic Equivalent of Task (MET) units per week.

From baseline to week 12

Colaboradores e Investigadores

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

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Lindsey B Wooliscroft, MD, Oregon Health and Science University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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 (Actual)

29 de abril de 2021

Finalización primaria (Actual)

27 de marzo de 2025

Finalización del estudio (Actual)

27 de marzo de 2025

Fechas de registro del estudio

Enviado por primera vez

26 de agosto de 2020

Primero enviado que cumplió con los criterios de control de calidad

31 de agosto de 2020

Publicado por primera vez (Actual)

4 de septiembre de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de septiembre de 2026

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

27 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • STUDY00021045
  • K23HD101667 (Subvención/contrato del NIH de EE. UU.)
  • UL1TR002369 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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. .