Impact of Exercise Training on Serum Neurofilament Light Chain (NfL), Brain Volumetry, and Functional Outcomes in Multiple Sclerosis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFirat University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise

    Other intervention

    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

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: ExerciseExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

MRI Acquisition and Volumetric Analysis

Volumetric brain analysis will be conducted using VolBrain, an open-access automated segmentation platform for brain MRI.

Time frame
12 weeks
2

Serum Neurofilament Light Chain (NfL) measurement

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.

Time frame
12 Weeks

Secondary outcomes

1

Multiple Sclerosis Functional Composite

Multiple Sclerosis Functional Composite (MSFC) is a standardized, quantitative tool used to assess disability and functional changes in individuals with multiple sclerosis .

Time frame
12 Weeks
2

Fatigue Impact Scale

The Fatigue Impact Scale (FIS) was used to evaluate the effect of fatigue on daily activities in individuals with MS.

Time frame
12 Weeks
3

Short form-12 version 2 (SF-12v2)

The SF-12v2 is a psychometrically validated, reliable, generic HRQoL instrument that assesses patients' physical and mental health. It is a short form of the SF-36, which is frequently used in clinical trials. The SF-12v2 consists of 12 questions from the SF-36 that evaluate the exact eight health domains as the SF-36: physical function, the role-physical, bodily pain, general health, vitality, social function, the role-emotional and mental health. The Physical Component Summary (PCS) and Mental Component Summary (MCS) scores are norm-based scores ranging from 0 to 100 calculated from the responses to the 12 questions using scoring software.

Time frame
12 Weeks
4

Problem-Solving inventory (PSI)

In the Likert-type inventory, each item is scored between 1 and 6. Three items are excluded from the scoring. Certain inventory items are reverse-scored. It is assumed that 32 items represent adequate problem-solving skills. A high scale score indicates that the individual considers him/herself inadequate, exhibits avoidance-attachment behavior, and does not feel personal control. The scale scores could range between 32 and 192

Time frame
12 Weeks

Other outcomes

Sponsors and contacts

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