Multiple Sclerosis
Conditions
Keywords
Exercise, Irisin, Brain Volume
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. Sex-stratified 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
OTHERExercise
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 minute 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
Sponsors
Firat University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
All clinical assessments will be performed by a blinded neurologist to eliminate measurement bias.
Intervention model description
This single-blind, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Clinically confirmed relapsing-remitting multiple sclerosis (RRMS) diagnosis according to revised McDonald criteria (2017) * Aged 19-65 years (inclusive) * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRI Acquisition and Volumetric Analysis | 12 weeks | Volumetric brain analysis will be conducted using VolBrain, an open-access automated segmentation platform for brain MRI. |
| Serum irisin hormone measurement | 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 pg/ml will be used for serum irisin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multiple Sclerosis Functional Composite | 12 weeks | Multiple Sclerosis Functional Composite (MSFC) is a standardized, quantitative tool used to assess disability and functional changes in individuals with multiple sclerosis (MS). |
Countries
Turkey (Türkiye)
Outcome results
None listed