The Effect of an Exercise Intervention on Serum Neurofilament Light Chain and Brain Volumetry in Patients With Multiple Sclerosis: A Randomized Controlled Trial
Exercise study for Multiple Sclerosis patients to track brain health markers.
Plain English Summary
Impact of Exercise Training on Serum Neurofilament Light Chain (NfL), Brain Volumetry, and Functional Outcomes in Multiple Sclerosis is a Not Applicable clinical trial sponsored by Firat University studying Multiple Sclerosis, Exercise, Neurofilament Light Chain. This study tests if a 12-week exercise program can improve brain health markers and reduce nerve damage in people with Multiple Sclerosis. It is for adults diagnosed with relapsing-remitting Multiple Sclerosis who have mild to moderate disability. Participants will be randomly assigned to either an exercise group or a control group for 12 weeks, with assessments before and after. Alternatives include standard care and other MS treatments, but this study focuses on the specific impact of a structured exercise regimen. The trial aims to enroll 26 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you have a confirmed diagnosis of relapsing-remitting Multiple Sclerosis and have mild to moderate disability (EDSS score 1.0-5.5). You cannot join if you have had an MS relapse recently, are already exercising regularly, have other health conditions that limit exercise, or have contraindications for MRI scans. Participants must not have taken corticosteroids in the last 3 months and must not have started or changed MS medications in the last 6 months. The study is for adults and requires the ability to participate in supervised exercise sessions. This trial is studying Multiple Sclerosis, Exercise, Neurofilament Light Chain, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes measure changes in a marker of nerve damage in the blood (Neurofilament Light Chain) and the size of different brain areas using MRI scans, indicating how the exercise program mig The specific primary outcome measures are: MRI Acquisition and Volumetric Analysis (12 weeks); Serum Neurofilament Light Chain (NfL) measurement (12 Weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it investigates a non-pharmacological intervention, exercise, to potentially slow down nerve damage and brain volume loss in Multiple Sclerosis, addressing a gap in managing This research targets Multiple Sclerosis, Exercise, Neurofilament Light Chain, where improved treatment options are needed.
Investor Insight
This trial signals interest in non-drug interventions for MS, a condition with a significant patient population and growing market for supportive therapies, suggesting potential for exercise-based pro
Is This Trial Right for Me?
Ask your doctor if this exercise program is safe and appropriate for your specific MS condition and overall health. Participation involves attending supervised exercise sessions three times a week for 12 weeks, along with MRI scans and blood tests at the beginning and end of the study. Be prepared for the time commitment of attending sessions and undergoing assessments, and discuss any concerns about the exercise intensity or potential side effects with the study team. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: SINGLE
- Enrollment: 26 participants
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 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
Primary Outcomes
- MRI Acquisition and Volumetric Analysis (12 weeks)
- Serum Neurofilament Light Chain (NfL) measurement (12 Weeks)
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)
Full 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 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)
Trial Locations
- Fırat University, Elâzığ, Turkey (Türkiye)
Frequently Asked Questions
What is clinical trial NCT07520812?
NCT07520812 is a Not Applicable INTERVENTIONAL study titled "Impact of Exercise Training on Serum Neurofilament Light Chain (NfL), Brain Volumetry, and Functional Outcomes in Multiple Sclerosis." It is currently not yet recruiting and is sponsored by Firat University. The trial targets enrollment of 26 participants.
What conditions does NCT07520812 study?
This trial investigates treatments for Multiple Sclerosis, Exercise, Neurofilament Light Chain. The primary condition under study is Multiple Sclerosis.
What treatments are being tested in NCT07520812?
The interventions being studied include: Exercise (OTHER). 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
What does Not Applicable mean for NCT07520812?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07520812?
This trial is currently "Not Yet Recruiting." It started on 2026-04-15. The estimated completion date is 2026-08-15.
Who is sponsoring NCT07520812?
NCT07520812 is sponsored by Firat University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07520812?
The trial aims to enroll 26 participants. The trial has not yet started recruiting.
How is NCT07520812 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT07520812?
The primary outcome measures are: MRI Acquisition and Volumetric Analysis (12 weeks); Serum Neurofilament Light Chain (NfL) measurement (12 Weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07520812 being conducted?
This trial is being conducted at 1 site, including Elâzığ (Turkey (Türkiye)).
Where can I find official information about NCT07520812?
The official record for NCT07520812 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07520812. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07520812 testing in simple terms?
This study tests if a 12-week exercise program can improve brain health markers and reduce nerve damage in people with Multiple Sclerosis. It is for adults diagnosed with relapsing-remitting Multiple Sclerosis who have mild to moderate disability.
Why is this trial significant?
This trial matters because it investigates a non-pharmacological intervention, exercise, to potentially slow down nerve damage and brain volume loss in Multiple Sclerosis, addressing a gap in managing
What are the potential risks of participating in NCT07520812?
Potential risks include muscle soreness, fatigue, or minor injuries from exercise, which will be monitored by a physiotherapist. Some participants might experience temporary worsening of MS symptoms due to physical exertion, though this is closely managed. There are risks associated with MRI scans, such as discomfort from lying in the scanner or reactions to contrast agents if used. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07520812?
Ask your doctor if this exercise program is safe and appropriate for your specific MS condition and overall health. Participation involves attending supervised exercise sessions three times a week for 12 weeks, along with MRI scans and blood tests at the beginning and end of the study. Be prepared for the time commitment of attending sessions and undergoing assessments, and discuss any concerns about the exercise intensity or potential side effects with the study team. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07520812 signal from an investment perspective?
This trial signals interest in non-drug interventions for MS, a condition with a significant patient population and growing market for supportive therapies, suggesting potential for exercise-based pro This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will be randomly assigned to either an exercise group or a control group for 12 weeks, with assessments before and after. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.