The Effect of an Exercise Intervention on Serum Glial Fibrillary Acidic Protein (GFAP), Brain Volumetry and and Functional Outcomes in Patients With Multiple Sclerosis: A Randomized Controlled Trial

Not yet recruitingNot a drug-phase studyRelapsing MSNCT07521995

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Exercise

What it measured

Main measures

  • MRI Acquisition and Volumetric Analysis

    12 Weeks

    MRI lesions
  • Serum Glial Fibrillary Acidic Protein measurement

    12 Weeks

Other measures (5)

  • Multiple Sclerosis Functional Composite

    12 Weeks

    Disability progression
  • Fatigue Impact Scale

    12 Weeks

    Fatigue
  • Short form-12 version 2 (SF-12v2)

    12 Weeks

    PainQuality of life (reported by participants)
  • Problem-Solving Inventory (PSI)

    12 Weeks

    Bladder, bowel and sexual function
  • Emotional intelligence scale (EIS)

    12 Weeks

Who could take part

Relapsing MS · 18 to 65 · EDSS 1.0 to 5.5

Show the full criteria

Inclusion criteria

* Clinically confirmed relapsing-remitting multiple sclerosis (RRMS) diagnosis according to revised McDonald criteria (2017) * Mild-to-moderate disability (EDSS score 1.0-5.5) * No corticosteroid treatment within the previous 3 months

Exclusion criteria

* Acute MS relapse within 90 days before enrollment * Regular participation in structured exercise programs (>3 hours/week) * Comorbid conditions that may limit exercise participation, including significant orthopedic impairments, unstable cardiopulmonary conditions, and other systemic disorders affecting physical activity * Standard MRI contraindications (metallic implants, claustrophobia, etc.) * Concurrent neurological disorders (other than MS) * Initiation or modification of disease-modifying therapy within 6 months * Severe spasticity (Modified Ashworth Scale ≥3 in any major muscle group)

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

This single-blind, randomized controlled trial will employ a two-arm parallel design (exercise group vs. control group) with a 12-week intervention period. Randomization will be implemented using SPSS 25.0 (IBM Corporation, Armonk, NY, USA) to ensure balanced group allocation. All outcome measures will be assessed at baseline and post-intervention.

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History

    1. Started

      May 2026

    2. Main results due

      May 2026

    3. Finished

      Sept 2026

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