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Набор скоро начнётся NCT07640100

EFFECTS OF AEROBIC AND RESISTANCE TRAINING ON IMMUNE FUNCTION IN MULTIPLE SCLEROSIS

Без фазы С лечением Multiple Sclerosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Aerobic and Progressive Resistance Exercise Program, Standard Care (in control arm).
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis. Базовые параметры: 19 лет — 45 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

EVALUATION OF THE EFFECTS OF AEROBIC AND RESISTANCE EXERCISES ON THE IMMUNE SYSTEM AND FUNCTIONAL CAPACITY IN MULTIPLE SCLEROSIS

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Aerobic and Progressive Resistance Exercise Program
    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 e
  • Другое Standard Care (in control arm)
    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.

Первичные конечные точки

  • CHANGE FROM BASELINE IN SERUM PROINFLAMMATORY CYTOKINE LEVELS [Срок оценки: Baseline and Post-intervention (e.g., Week 8)]
Вторичные конечные точки (5)
  • CHANGE FROM BASELINE IN FUNCTIONAL EXERCISE CAPACITY [Срок оценки: Baseline and Post-intervention (e.g., Week 8)]
  • CHANGE FROM BASELINE IN TIMED 25-FOOT WALK (T25FW) [Срок оценки: Baseline and Post-intervention (e.g., Week 8)]
  • CHANGE FROM BASELINE IN PERCEIVED FATIGUE IMPACT [Срок оценки: Baseline and Post-intervention (e.g., Week 8)]
  • CHANGE FROM BASELINE IN 9-HOLE PEG TEST (9HPT) [Срок оценки: Baseline and Post-intervention (e.g., Week 8)]
  • CHANGE FROM BASELINE IN PACED AUDITORY SERIAL ADDITION TEST (PASAT-3) [Срок оценки: Baseline and Post-intervention (e.g., Week 8)]

Критерии участия

Критерии включения

  • 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).

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Van Regional Training and Research Hospital — Van

Идентификаторы

NCT: NCT07640100 · KAD-FR-42

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗