Multiple SclerosisNCT07521995
Impact of Exercise Training on Serum Glial Fibrillary Acidic Protein (GFAP), Brain Volumetry, and Functional Outcomes in Multiple Sclerosis
A study testing Exercise in people with Multiple Sclerosis and Exercise, run by Firat University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Exercise, Function
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Fırat University
Elâzığ, 23100
Mustafa Kaplan, MD Professor, +904242370000, mustafakaplan@firat.edu.tr
About this study
Official 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
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Exercise, Function
- Being tested
- Exercise
- Keywords
- Exercise, Glial Fibrillary Acidic Protein, Brain Volume
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 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 Receives: Other: Exercise |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI Acquisition and Volumetric Analysis
Volumetric brain analysis will be conducted using VolBrain, an open-access automated segmentation platform for brain MRI.
Measured: 12 Weeks
Serum Glial Fibrillary Acidic Protein 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 Glial Fibrillary Acidic Protein.
Measured: 12 Weeks
Secondary outcomes (5)
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.
Measured: 12 Weeks
Fatigue Impact Scale
The Fatigue Impact Scale (FIS) was used to evaluate the effect of fatigue on daily activities in individuals with MS.
Measured: 12 Weeks
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 responses to the 12 questions using scoring software.
Measured: 12 Weeks
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 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
Measured: 12 Weeks
Emotional intelligence scale (EIS)
''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).
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This single-blind, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furkan Bilek, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521995
- Sponsor's protocol ID
- 23100
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07521995
- Acronym / sponsor ID
- 23100
- Conditions
- Multiple Sclerosis, Exercise, Function
- Keywords
- Exercise, Glial Fibrillary Acidic Protein, Brain Volume
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This single-blind, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseBased 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 |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAccording 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 | Other | Exercise |
Primary outcome
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.
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.
5 secondary outcomes
Multiple Sclerosis Functional Composite
Time frame: 12 Weeks
Fatigue Impact Scale
Time frame: 12 Weeks
Short form-12 version 2 (SF-12v2)
Time frame: 12 Weeks
Problem-Solving Inventory (PSI)
Time frame: 12 Weeks
Emotional intelligence scale (EIS)
Time frame: 12 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Multiple Sclerosis and Exercise, run by Firat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Furkan Bilek, PhD (+905442772249, fzt.furkanbilek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI Acquisition and Volumetric Analysis (time frame: 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.