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

April 3, 2026 updated by: Furkan Bilek, Firat University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Exercise
Based on current recommendations for individuals with MS, the PRT program lasted 12 weeks and included three sessions per week, each lasting 60-90 min at 60-80% of one-repetition maximum. The training sessions were conducted three times per week over the 12-week period and were supervised by a qualified physiotherapist
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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Weeks
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.
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Weeks
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.
12 Weeks
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.
12 Weeks
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
12 Weeks
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).
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Firat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared with external researchers to ensure the full protection of participant privacy and to maintain confidentiality in accordance with the informed consent forms approved by the Institutional Review Board. The ethical approval obtained for this study does not include explicit permission for the public sharing of raw individual data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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