Impact of Exercise Training on Serum Glial Fibrillary Acidic Protein (GFAP), Brain Volumetry, and Functional Outcomes in Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, Exercise, Function. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
The exercise intervention will consist of supervised progressive resistance training sessions conducted three times weekly (with a minimum 48-hour rest period between sessions) at Firat University Hospital. Control participants will maintain their usual daily activities without participating in any structured exercise programs. A blinded neurologist will perform all clinical assessments to eliminate measurement bias. To control for circadian variations, all evaluations will be scheduled at consistent times of day for each participant. Environmental conditions will be strictly maintained during testing sessions (ambient temperature: 21-22°C; humidity: 55-60%). This study will be designed and reported in accordance with CONSORT guidelines for randomized trials, incorporating all essential elements for transparent randomized controlled reporting, including allocation concealment, blinding procedures, and intention-to-treat principles.
Interventions
- Other Exercise
According to current clinical guidelines for multiple sclerosis patients, the progressive resistance training (PRT) protocol will be implemented as follows: a 12-week intervention consisting of three supervised 60-90 minutes sessions per week at 60-80% of one-repetition maximum intensity. All training sessions will be conducted under the direct supervision of a certified physiotherapist to ensure proper technique adherence and safety throughout the intervention period
Primary outcome measures
- MRI Acquisition and Volumetric Analysis [Time frame: 12 Weeks]
- Serum Glial Fibrillary Acidic Protein measurement [Time frame: 12 Weeks]
Secondary outcome measures (5)
- Multiple Sclerosis Functional Composite [Time frame: 12 Weeks]
- Fatigue Impact Scale [Time frame: 12 Weeks]
- Short form-12 version 2 (SF-12v2) [Time frame: 12 Weeks]
- Problem-Solving Inventory (PSI) [Time frame: 12 Weeks]
- Emotional intelligence scale (EIS) [Time frame: 12 Weeks]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Fırat University — Elâzığ
Identifiers
NCT: NCT07521995 · 23100