The Effect of an Exercise Intervention on Serum Neurofilament Light Chain and Brain Volumetry in Patients With Multiple Sclerosis: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- MRI Acquisition and Volumetric Analysis
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
All clinical assessments will be performed by a blinded neurologist to eliminate measurement bias.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 prior to 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)
Arms & Interventions
Exercise
Based on current recommendations for individuals with MS, the PRT program will last 12 weeks and will include three sessions per week, each lasting 60-90 minutes at 60-80% of one-repetition maximum.
Intervention: Exercise (Other)
Control
Outcomes
Primary Outcomes
MRI Acquisition and Volumetric Analysis
Time Frame: 12 weeks
Volumetric brain analysis will be conducted using VolBrain, an open-access automated segmentation platform for brain MRI.
Serum Neurofilament Light Chain (NfL) measurement
Time Frame: 12 Weeks
All patients will be asked to provide blood samples in the morning following their overnight (12 h) fast before and after the study. The unit ng/ml will be used for serum Neurofilament Light Chain.
Secondary Outcomes
- Multiple Sclerosis Functional Composite(12 Weeks)
- Fatigue Impact Scale(12 Weeks)
- Short form-12 version 2 (SF-12v2)(12 Weeks)
- Problem-Solving inventory (PSI)(12 Weeks)
- Emotional intelligence scale (EIS)(12 Weeks)
Investigators
Furkan Bilek
Principal Investigator
Firat University