- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07640100
EFFECTS OF AEROBIC AND RESISTANCE TRAINING ON IMMUNE FUNCTION IN MULTIPLE SCLEROSIS (ABIF-MS)
EVALUATION OF THE EFFECTS OF AEROBIC AND RESISTANCE EXERCISES ON THE IMMUNE SYSTEM AND FUNCTIONAL CAPACITY IN MULTIPLE SCLEROSIS
Background: Multiple Sclerosis (MS) is a chronic immune-mediated, inflammatory, and neurodegenerative central nervous system disorder characterized by axonal damage. This damage leads to various debilitating symptoms such as muscle weakness, fatigue, balance loss, and cognitive decline. While reductions in aerobic capacity and muscle strength are secondary manifestations of MS, physical exercise serves as a crucial therapeutic strategy to manage symptoms and optimize functionality.
Rationale: Aerobic exercise exerts anti-inflammatory effects by reducing adipose tissue mass, promoting anti-inflammatory macrophage polarization, and downregulating toll-like receptors. It also modulates the altered T-helper cytokine balance in MS (characterized by elevated proinflammatory cytokines like IL-1, IL-6, IL-17, IFN-γ, TNF-α and decreased anti-inflammatory IL-10), potentially slowing myelin destruction. Concurrently, progressive resistance training (typically at 60%-80% of maximum voluntary contraction) has been shown to improve muscle strength and reduce perceived fatigue in this population. However, data regarding the specific impacts of these exercise modalities on the immune system remain limited.
Objective:The aim of this randomized controlled trial is to investigate and compare the effects of AEROBIC AND STRENGTHENING (RESISTANCE) EXERCISES ON THE IMMUNE SYSTEM PARAMETERS (SPECIFICALLY CYTOKINE PROFILES) AND OVERALL FUNCTIONALITY IN INDIVIDUALS DIAGNOSED WITH MULTIPLE SCLEROSIS.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Multiple Sclerosis (MS) is recognized as a chronic immune-mediated, inflammatory, and neurodegenerative disorder of the central nervous system (CNS) characterized by axonal damage that disrupts neural conduction. The neurodegenerative nature of this neurological disease manifests through a wide spectrum of debilitating symptoms, including muscle weakness, fatigue, loss of balance, speech impairment, diplopia, and cognitive decline. These neurological signs and symptoms vary depending on the anatomical location of the lesions.
As an effective rehabilitation strategy for individuals with MS, exercise manages symptoms, restores function, optimizes quality of life, promotes wellness, and encourages participation in activities of daily living. Previous studies have demonstrated that aerobic activity is inversely associated with MS symptoms, exerting protective and potentially restorative effects. Furthermore, growing evidence suggests that exercise can be considered a disease-modifying therapy in MS. Although reductions in aerobic capacity and endurance are not primary clinical features of MS, they frequently develop as secondary manifestations. Therefore, strategies designed to enhance aerobic endurance and capacity, such as aerobic exercise, are highly valuable in MS management. Consequently, aerobic-based exercise interventions are frequently utilized in the therapeutic management of MS to improve aerobic endurance and capacity. Aerobik exercise is a modality designed to stress the cardiovascular system through continuous, rhythmic engagement of large muscle groups (e.g., jogging, walking, swimming, rowing, and cycle ergometry).
The anti-inflammatory effect of aerobic exercise may prevent systemic inflammatory progression. Exercise counteracts inflammation by reducing adipose tissue mass, which promotes the polarization of macrophages toward an anti-inflammatory state, thereby limiting cytokine production. Additionally, the downregulation of toll-like receptors associated with decreased inflammatory monocytes occurs. The inflammatory state is also modulated in response to exercise stimulation by increased levels of skeletal muscle-derived interleukin-6 (IL-6) and the prevention of sustained cytokine release associated with obesity. Cytokines, critical components of MS pathophysiology, are protein hormones that regulate communication between the innate and adaptive branches of the immune system. In healthy populations, a homeostatic balance exists among T-helper cytokines; however, this balance is altered in MS, reflecting increased proinflammatory cytokines (IL-1, IL-6) and decreased anti-inflammatory cytokines (IL-10). These aberrations can accelerate myelin destruction in the brain and spinal cord. Data regarding the effects of physical activity on the immune system in MS remain limited. Cytokines, the primary focus of exercise-based MS studies, encompass a spectrum of proinflammatory cytokines, including IL-1, IL-2, IL-6, IL-17, interferon-gamma (IFN-γ), and tumor necrosis factor-alpha (TNF-α). Most of these cytokines are well-documented contributors to MS pathogenesis.
Recently, there has been a growing interest in resistance exercise training. Resistance training studies in individuals with MS have reported improvements in leg strength, reductions in perceived fatigue, and increases in muscle power. Resistance training protocols in this population have generally been of low-to-moderate intensity, typically utilizing progressive resistance exercise ranging from 60% to 80% of the maximum voluntary contraction.
The aim of this study is to conduct a randomized controlled trial to investigate the EFFECTS OF AEROBIC AND STRENGTHENING EXERCISES ON THE IMMUNE SYSTEM AND FUNCTIONALITY IN INDIVIDUALS DIAGNOSED WITH MULTIPLE SCLEROSIS.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: berna beren yıldırımoğlu, specialist physiotherapist
- Número de teléfono: +905550823309
- Correo electrónico: calppberna@hotmail.com
Ubicaciones de estudio
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Ipekyolu
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Van, Ipekyolu, Turquía (Türkiye), 65100
- Van Regional Training and Research Hospital
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Contacto:
- VAN REGIONAL TRAINING AND RESEARCH HOSPITAL REGIONAL TRAINING AND RESEARCH HOSPITAL
- Número de teléfono: +905555798488
- Correo electrónico: dr_m_okay@hotmail.com
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Contacto:
- muhammed örün, specialist
- Número de teléfono: +905555798488
- Correo electrónico: dr_m_okay@hotmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS). Aged between 19 and 45 years. Expanded Disability Status Scale (EDSS) score between 0.5 and 3.5. Not currently receiving steroid therapy (or having no recent corticosteroid treatment within the specified washout period).
Exclusion Criteria:
- Having a high baseline level of physical activity.
Experiencing an acute MS relapse or having a history of a relapse within the past 3 months.
Presence of any orthopedic or bone pathology that would prevent participation in the exercise program.
Concomitant diagnosis of any known neuromuscular or immunological disease other than MS.
Initiating immunomodulatory therapy within the last 6 months.
Presence of visual involvement or symptomatic diplopia.
High-grade lower extremity spasticity, defined as a Modified Ashworth Scale (MAS) score of 3 or 4.
Abnormal white blood cell (WBC) count outside the normal reference range of 4,000-10,000 cells/µL.
Presence of any severe cardiopulmonary condition that would contraindicate or prevent participation in physical exercise.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: MS Exercise group
Participants diagnosed with Multiple Sclerosis who will perform a structured exercise program consisting of both aerobic training and progressive strengthening (resistance) exercises.
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A structured, supervised exercise program consisting of both aerobic and progressive strengthening (resistance) exercises.
Aerobic exercises will include continuous, rhythmic activities involving large muscle groups (e.g., cycle ergometry, walking).
Progressive resistance training will target major muscle groups, typically utilizing an intensity ranging from 60% to 80% of the maximum voluntary contraction (MVC).
The duration, frequency, and total weeks of the program will be identical for both exercise arms.
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Comparador activo: MS Control Group
Participants diagnosed with Multiple Sclerosis who will maintain their current routine medical care and daily life activities without participating in any structured exercise intervention during the study period.
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Participants in this arm will maintain their current routine medical follow-ups and standard daily life activities.
They will not participate in any structured or supervised physical exercise program during the study period.
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Experimental: healthy Control Group
Age- and gender-matched healthy individuals who will perform the identical structured exercise program (consisting of aerobic and progressive strengthening exercises) as the MS Exercise Group.
This arm will serve to compare the physiological, functional, and immunological (cytokine profiles) responses to exercise between healthy individuals and individuals with MS.
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A structured, supervised exercise program consisting of both aerobic and progressive strengthening (resistance) exercises.
Aerobic exercises will include continuous, rhythmic activities involving large muscle groups (e.g., cycle ergometry, walking).
Progressive resistance training will target major muscle groups, typically utilizing an intensity ranging from 60% to 80% of the maximum voluntary contraction (MVC).
The duration, frequency, and total weeks of the program will be identical for both exercise arms.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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CHANGE FROM BASELINE IN SERUM PROINFLAMMATORY CYTOKINE LEVELS
Periodo de tiempo: Baseline and Post-intervention (e.g., Week 8)
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Circulating serum levels of proinflammatory cytokines-specifically Interleukin-1 (IL-1), Interleukin-6 (IL-6), Interleukin-17 (IL-17), Interferon-gamma (IFN-γ), and Tumor Necrosis Factor-alpha (TNF-α)-will be analyzed via Enzyme-Linked Immunosorbent Assay (ELISA) to evaluate the anti-inflammatory effect of the exercise program.
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Baseline and Post-intervention (e.g., Week 8)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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CHANGE FROM BASELINE IN FUNCTIONAL EXERCISE CAPACITY
Periodo de tiempo: Baseline and Post-intervention (e.g., Week 8)
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Evaluated using the 6-Minute Walk Test (6MWT).
The total distance walked in meters within 6 minutes will be recorded to assess functional exercise capacity and aerobic endurance.
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Baseline and Post-intervention (e.g., Week 8)
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CHANGE FROM BASELINE IN TIMED 25-FOOT WALK (T25FW)
Periodo de tiempo: Baseline and Post-intervention (e.g., Week 8)
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A MEASURE OF QUANTITATIVE MOBILITY AND LEG FUNCTION BASED ON THE TIME REQUIRED TO WALK 25 FEET AS QUICKLY AS POSSIBLE.
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Baseline and Post-intervention (e.g., Week 8)
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CHANGE FROM BASELINE IN PERCEIVED FATIGUE IMPACT
Periodo de tiempo: Baseline and Post-intervention (e.g., Week 8)
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Assessed using the Modified Fatigue Impact Scale (MFIS).
This 21-item self-report questionnaire evaluates the perceived impact of fatigue on physical, cognitive, and psychosocial functioning.
Total scores range from 0 to 84, with higher scores indicating a greater negative impact of fatigue.
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Baseline and Post-intervention (e.g., Week 8)
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CHANGE FROM BASELINE IN 9-HOLE PEG TEST (9HPT)
Periodo de tiempo: Baseline and Post-intervention (e.g., Week 8)
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A MEASURE OF UPPER EXTREMITY (ARM AND HAND) FUNCTION BASED ON THE TIME REQUIRED TO PLACE AND REMOVE 9 PEGS IN A PEG BOARD.
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Baseline and Post-intervention (e.g., Week 8)
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CHANGE FROM BASELINE IN PACED AUDITORY SERIAL ADDITION TEST (PASAT-3)
Periodo de tiempo: Baseline and Post-intervention (e.g., Week 8)
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A MEASURE OF COGNITIVE FUNCTION, AUDITORY INFORMATION PROCESSING SPEED, AND CALCULATION ABILITY.
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Baseline and Post-intervention (e.g., Week 8)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: seda saka, Assoc. Prof. Dr., Haliç University
Publicaciones y enlaces útiles
Enlaces Útiles
- ACUTE EFFECTS OF AEROBIC INTENSITIES ON THE CYTOKINE RESPONSE IN WOMEN WITH T MILD MULTIPLE SCLEROSIS
- INFLUENCE OF COMBINED FUNCTIONAL RESISTANCE AND ENDURANCE EXERCISE OVER 12 WEEKS ON MATRIX METALLOPROTEINASE-2 SERUM CONCENTRATION IN PERSONS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS - A COMMUNITY-BASED RANDOMIZED CONTROLLED TRIAL
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Enfermedades Autoinmunes Desmielinizantes, SNC
- Enfermedades Autoinmunes del Sistema Nervioso
- Enfermedades desmielinizantes
- Esclerosis múltiple
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Calidad de la atención médica
- Indicadores de calidad, atención médica
- Estándar de cuidado
Otros números de identificación del estudio
- KAD-FR-42
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Datos del estudio/Documentos
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Protocolo de estudio
Identificador de información: Study Protocol and SAPComentarios de información: Available after publication.
Información sobre medicamentos y dispositivos, documentos del estudio
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