The Effect of an Exercise Intervention on Serum Neurofilament Light Chain and Brain Volumetry in Patients With Multiple Sclerosis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- MRI Acquisition and Volumetric Analysis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All clinical assessments will be performed by a blinded neurologist to eliminate measurement bias.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Exercise (Other)
Control
结局指标
主要结局
MRI Acquisition and Volumetric Analysis
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Furkan Bilek
Principal Investigator
Firat University