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NCT Number: NCT07521995

Impact of Exercise Training on Serum Glial Fibrillary Acidic Protein (GFAP), Brain Volumetry, and Functional Outcomes in Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Exercise Function Immune System Diseases Motor Activity Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 before 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)

Treatment and study plan

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 minutes 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

  1. 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.

  2. Serum Glial Fibrillary Acidic Protein 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 Glial Fibrillary Acidic Protein.

Secondary outcomes

  1. Multiple Sclerosis Functional Composite

    Time frame: 12 Weeks

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

  2. Fatigue Impact Scale

    Time frame: 12 Weeks

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

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

    Time frame: 12 Weeks

    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 responses to the 12 questions using scoring software.

  4. Problem-Solving Inventory (PSI)

    Time frame: 12 Weeks

    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 large-scale score indicates that the individual considers him/herself inadequate, exhibits avoidance-attachment behavior, and lacks personal control. The scale scores could range between 32 and 192

  5. Emotional intelligence scale (EIS)

    Time frame: 12 Weeks

    ''Emotional Intelligence Assessment Scale" includes five subscales: Emotional awareness (items 1, 2, 4, 17, 19, 25), emotion management (items 3, 7, 8, 10, 18, 30), self-motivation (items 5, 6, 13, 14, 16, 22), empathy (items 9, 11, 20, 21, 23, 28), relationship control (items 12, 15, 24, 26, 27, 29). The 6-point Likert-type scale (1: completely disagree, 2: partially disagree, 3: slightly disagree, 4: slightly agree, 5: partially agree, 6: completely agree) includes 30 items. There are no reverse-scored items. A total score of 155 or higher is considered high (very strong), scores between 130 and 150 are considered normal (some improvement needed), and scores of 129 and below are considered low (definitely needed improvement).

Study contacts

Contact information is provided by the study sponsor or research team.

Furkan Bilek, PhD

CONTACT

[email protected]

+905442772249

Sponsors and collaborators

Lead sponsor

Firat University

Other

Registry information

Official study title

The Effect of an Exercise Intervention on Serum Glial Fibrillary Acidic Protein (GFAP), Brain Volumetry and and Functional Outcomes in Patients With Multiple Sclerosis: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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