Ejercicio aeróbico para la remielinización en la esclerosis múltiple
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
Estado
Condiciones
Condiciones
Intervención / Tratamiento
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
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Oregon Health & Science University
-
-
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
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
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / 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
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
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
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
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Lindsey B Wooliscroft, MD, Oregon Health and Science University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Procesos Patológicos
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Leucoencefalopatías
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Esclerosis múltiple
- Esclerosis
- Enfermedades del Sistema Nervioso
- Enfermedades Autoinmunes del Sistema Nervioso
- Enfermedades desmielinizantes
- Enfermedades Autoinmunes Desmielinizantes, SNC
- Actividad del motor
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Ejercicio
Otros números de identificación del 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)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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