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

Not yet recruitingNot a drug-phase studyRelapsing MSNCT07640100

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Aerobic and Progressive Resistance Exercise Program

Compared with

  • Standard Care (in control arm)

What it measured

Main measures

  • CHANGE FROM BASELINE IN SERUM PROINFLAMMATORY CYTOKINE LEVELS

    Baseline and Post-intervention (e.g., Week 8)

    Physical functionImmune response

Other measures (5)

  • CHANGE FROM BASELINE IN FUNCTIONAL EXERCISE CAPACITY

    Baseline and Post-intervention (e.g., Week 8)

    Walking and mobilityPhysical function
  • CHANGE FROM BASELINE IN TIMED 25-FOOT WALK (T25FW)

    Baseline and Post-intervention (e.g., Week 8)

    Disability progressionWalking and mobility
  • CHANGE FROM BASELINE IN PERCEIVED FATIGUE IMPACT

    Baseline and Post-intervention (e.g., Week 8)

    Thinking and memoryFatigue
  • CHANGE FROM BASELINE IN 9-HOLE PEG TEST (9HPT)

    Baseline and Post-intervention (e.g., Week 8)

    Disability progressionArm and hand function
  • CHANGE FROM BASELINE IN PACED AUDITORY SERIAL ADDITION TEST (PASAT-3)

    Baseline and Post-intervention (e.g., Week 8)

    Thinking and memory

Who could take part

Relapsing MS · 19 to 45 · EDSS 0.5 to 3.5

Show the full criteria

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

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History

    1. Started

      Jun 2026

    2. Main results due

      Aug 2026

    3. Finished

      Dec 2026

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