Multiple SclerosisNCT07325019
THE EFFECTS OF AEROBİC EXERCİSE ON NEUROVASCULAR UNİT AND CLİNİCAL PROGRESSİON MARKERS İN INDİVİDUALS WİTH MULTİPLE SCLEROSİS
A study testing aerobic exercise intervention in people with Multiple Sclerosis, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial summary
This study is a randomised controlled trial designed to thoroughly investigate the effects of aerobic exercise on NVU biomarkers in individuals with MS. The study was conducted between February and June 2025 at the MS clinic affiliated with the Department of Neurology, Faculty of Medicine, Ondokuz Mayıs University. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- aerobic exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having a definite diagnosis of MS according to McDonald criteria,
- Being aged between 20 and 50,
- Having a Standardised Mini Mental Test (SMMT) score of ≥24,
- Having an Expanded Disability Status Scale (EDSS) score between 0 and 4.0,
- Having no other serious health problems that would prevent exercise,
- Having had no change in medication in the last 6 months.
Who cannot join
- Having experienced an MS relapse within the last 6 months,
- Having an orthopaedic or systemic problem that would prevent participation in the exercises,
- Having another known neuromuscular disorder besides MS,
- Having received immunomodulatory treatment within the last 6 months,
- Having a cardiopulmonary disorder that could prevent participation in the exercise,
- Being pregnant or breastfeeding.
Show all 10Show fewer
- Criteria for exclusion from the study:
- Failure to attend three consecutive sessions of the exercise programme
- Change in ongoing pharmacological treatment or discontinuation of pharmacological treatment
- Development of a history of MS attacks or deterioration in health status
Trial locations and contacts
1 site in 1 country.
About this study
This study is a randomised controlled trial designed to thoroughly investigate the effects of aerobic exercise on NVU biomarkers in individuals with MS. The study was conducted between February and June 2025 at the MS clinic affiliated with the Department of Neurology, Faculty of Medicine, Ondokuz Mayıs University. Participants were randomly assigned to either a control group or an exercise group. Assessments were conducted at baseline (pre-assessment) and eight weeks after the intervention (post-assessment).
Read the detailed description
In multiple sclerosis (MS), impairments occur in many of the cell types involved in the functioning of the Neurovascular Unit (NVU). The study examined the relationship between aerobic exercise and biomarkers associated with NVU function in individuals with MS, including Neurofilament Light Chain (NfL), Vascular Endothelial Growth Factor (VEGF), Glial Fibrillary Acidic Protein (GFAP), and the effects of aerobic exercise on the 6-Minute Walk Test (6MWT), Timed Up and Go Test (TUG), and 9-Hole Peg Test (9HPT), which determine clinical progression.
Methods: Thirty RRMS patients with a confirmed diagnosis of MS who met the inclusion criteria were included in the study. Patients who scored 24 points or higher on the Standardised Mini Mental Test (SMMT) and had an EDSS score between 0 and 4 underwent pre-testing, which included a demographic data form, 6 DWT, TWT, and 9 DPT. Blood samples were collected for analysis of NfL, VEGF, and GFAP biomarkers. Patients were randomly assigned to either the control or exercise group, and the exercise group underwent an aerobic exercise programme for 8 weeks. After the exercise programme, all patients underwent the 6 DYT, ZKYT, and 9 DPT as a post-test, and blood samples were collected.
- Conditions
- Multiple Sclerosis
- Being tested
- aerobic exercise intervention
- Keywords
- Aerobic Exercise, Neurovascular Unit, Multiple Sclerosis, Biomarker, Clinical Progression
- Medical subject headings
- Multiple Sclerosis, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise interventionOther
The aerobic exercise programme was implemented over a total of 8 weeks, with two sessions per week, using a treadmill under the supervision of a specialist physiotherapist. Patients' functional capacities were determined by estimating VO2 peak using walking distance, heart rate, and blood pressure measured at 6 DYT. During the aerobic exercise programme, patients' heart rates and oxygen saturation levels were monitored using a pulse oximeter, and care was taken to ensure that the Borg Scale value perceived by patients was between 11 and 14. After the aerobic exercise programme ended, heart rate, blood pressure, and Borg Scale were monitored for at least 5 minutes until they returned to baseline values. The session duration was planned in accordance with the literature, consisting of three phases: a warm-up phase, a loading phase, and a cool-down phase, lasting a minimum of 30 minutes and a maximum of 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Each patient was recommended a conventional exercise programme tailored to their needs. These included exercises aimed at strengthening the lower extremities and torso, exercises targeting patients' balance and walking problems (progressing from hard to soft surfaces, from eyes open to eyes closed, and from a wide support base to a narrow support base), walking training exercises (ceremonial walking, walking with reduced support area, sideways walking exercises), and exercises targeting coordination problems (Frenkel coordination exercises from sitting and supine positions, depending on the patient's condition). |
| aerobic exercise | Active comparator | The aerobic exercise programme was implemented over a total of 8 weeks, with two sessions per week, using a treadmill under the supervision of a specialist physiotherapist. Patients' functional capacities were determined by estimating VO2 peak using walking distance, heart rate, and blood pressure measured at 6 DYT. During the aerobic exercise programme, patients' heart rates and oxygen saturation levels were monitored using a pulse oximeter, and care was taken to ensure that the Borg Scale value perceived by patients was between 11 and 14. After the aerobic exercise programme ended, heart rate, blood pressure, and Borg Scale were monitored for at least 5 minutes until they returned to baseline values. The session duration was planned in accordance with the literature, consisting of three phases: a warm-up phase, a loading phase, and a cool-down phase, lasting a minimum of 30 minutes and a maximum of 40 minutes. Receives: Other: aerobic exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical progression
The primary outcome of the study is to determine clinical progression in individuals with MS. Functional mobility, walking capacity, and upper extremity functions were measured to assess clinical progression. To this end, the 6-Minute Walk Test (6MWT), 9-Hole Peg Test (9HPT), and Timed Up and Go Test (TUG) were administered. In the E group, a significant decrease was observed in dominant and non-dominant DDPT times and TWT time, while a significant increase was observed in 6WWT distance (p<0.001). No significant change was observed in these parameters in the control group (p>0.05). In the intergroup comparison, the improvements in the Exercise Group were found to be statistically significantly more pronounced than in the control group (p<0.001). These findings indicate that an eight-week aerobic exercise programme has a positive effect on clinical progression markers in individuals with MS.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (1)
Neurovascular unit biomarkers
Secondary outcomes are biomarkers reflecting NVU function. Serum NfL, serum VEGF-a, and serum GFAP were measured as NVU markers. Measurements were performed using the ELISA method with blood samples taken in the morning after all participants had fasted.
Secondary outcome analyses revealed no significant change in NfL, VEGF-a, and GFAP levels in either within-group or between-group comparisons (p>0.05). This finding indicates that the eight-week aerobic exercise programme did not have a significant effect on NVU biomarkers.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Feb 2025
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elif Asan, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325019
- Sponsor's protocol ID
- 2024313
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The primary reason for not sharing individual participant data (IPD) from this study is the need to ensure the highest level of data privacy and participant confidentiality. It was determined that the data could not be fully anonymized without leaving a potential risk of re-identification; therefore, IPD will not be shared. In addition, the study protocol and ethics committee approval do not include the sharing of individual-level data. However, summary-level results from the study may be shared with researchers upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECTS OF AEROBİC EXERCİSE ON NEUROVASCULAR UNİT AND CLİNİCAL PROGRESSİON MARKERS İN INDİVİDUALS WİTH MULTİPLE SCLEROSİS
- ClinicalTrials.gov ID
- NCT07325019
- Acronym / sponsor ID
- 2024313
- Conditions
- Multiple Sclerosis
- Keywords
- Aerobic Exercise, Neurovascular Unit, Multiple Sclerosis, Biomarker, Clinical Progression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 8 Jan 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 study is a randomised controlled trial designed to thoroughly investigate the effects of aerobic exercise on NVU biomarkers in individuals with MS. The study was conducted between February and June 2025 at the MS clinic affiliated with the Department of Neurology, Faculty of Medicine, Ondokuz Mayıs University. Participants were randomly assigned to either a control group or an exercise group. Assessments were conducted at baseline (pre-assessment) and eight weeks after the intervention (post-assessment).
Detailed description
In multiple sclerosis (MS), impairments occur in many of the cell types involved in the functioning of the Neurovascular Unit (NVU). The study examined the relationship between aerobic exercise and biomarkers associated with NVU function in individuals with MS, including Neurofilament Light Chain (NfL), Vascular Endothelial Growth Factor (VEGF), Glial Fibrillary Acidic Protein (GFAP), and the effects of aerobic exercise on the 6-Minute Walk Test (6MWT), Timed Up and Go Test (TUG), and 9-Hole Peg Test (9HPT), which determine clinical progression.
Methods: Thirty RRMS patients with a confirmed diagnosis of MS who met the inclusion criteria were included in the study. Patients who scored 24 points or higher on the Standardised Mini Mental Test (SMMT) and had an EDSS score between 0 and 4 underwent pre-testing, which included a demographic data form, 6 DWT, TWT, and 9 DPT. Blood samples were collected for analysis of NfL, VEGF, and GFAP biomarkers. Patients were randomly assigned to either the control or exercise group, and the exercise group underwent an aerobic exercise programme for 8 weeks. After the exercise programme, all patients underwent the 6 DYT, ZKYT, and 9 DPT as a post-test, and blood samples were collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Each patient was recommended a conventional exercise programme tailored to their needs. These included exercises aimed at strengthening the lower extremities and torso, exercises targeting patients' balance and walking problems (progressing from hard to soft surfaces, from eyes open to eyes closed, and from a wide support base to a narrow support base), walking training exercises (ceremonial walking, walking with reduced support area, sideways walking exercises), and exercises targeting coordination problems (Frenkel coordination exercises from sitting and supine positions, depending on the patient's condition). |
| aerobic exercise | Active comparator | Other: aerobic exercise interventionThe aerobic exercise programme was implemented over a total of 8 weeks, with two sessions per week, using a treadmill under the supervision of a specialist physiotherapist. Patients' functional capacities were determined by estimating VO2 peak using walking distance, heart rate, and blood pressure measured at 6 DYT. During the aerobic exercise programme, patients' heart rates and oxygen saturation levels were monitored using a pulse oximeter, and care was taken to ensure that the Borg Scale value perceived by patients was between 11 and 14. After the aerobic exercise programme ended, heart rate, blood pressure, and Borg Scale were monitored for at least 5 minutes until they returned to baseline values. The session duration was planned in accordance with the literature, consisting of three phases: a warm-up phase, a loading phase, and a cool-down phase, lasting a minimum of 30 minutes and a maximum of 40 minutes. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Having a definite diagnosis of MS according to McDonald criteria,
- Being aged between 20 and 50,
- Having a Standardised Mini Mental Test (SMMT) score of ≥24,
- Having an Expanded Disability Status Scale (EDSS) score between 0 and 4.0,
- Having no other serious health problems that would prevent exercise,
Key exclusion criteria (10 listed)
- Having experienced an MS relapse within the last 6 months,
- Having an orthopaedic or systemic problem that would prevent participation in the exercises,
- Having another known neuromuscular disorder besides MS,
- Having received immunomodulatory treatment within the last 6 months,
- Having a cardiopulmonary disorder that could prevent participation in the exercise,
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 |
|---|---|---|
| aerobic exercise interventionThe aerobic exercise programme was implemented over a total of 8 weeks, with two sessions per week, using a treadmill under the supervision of a specialist physiotherapist. Patients' functional capacities were determined by estimating VO2 peak using walking distance, heart rate, and blood pressure measured at 6 DYT. During the aerobic exercise programme, patients' heart rates and oxygen saturation levels were monitored using a pulse oximeter, and care was taken to ensure that the Borg Scale value perceived by patients was between 11 and 14. After the aerobic exercise programme ended, heart rate, blood pressure, and Borg Scale were monitored for at least 5 minutes until they returned to baseline values. The session duration was planned in accordance with the literature, consisting of three phases: a warm-up phase, a loading phase, and a cool-down phase, lasting a minimum of 30 minutes and a maximum of 40 minutes. | Other | aerobic exercise |
Primary outcome
clinical progression
Time frame: From enrollment to the end of treatment at 8 weeks
The primary outcome of the study is to determine clinical progression in individuals with MS. Functional mobility, walking capacity, and upper extremity functions were measured to assess clinical progression. To this end, the 6-Minute Walk Test (6MWT), 9-Hole Peg Test (9HPT), and Timed Up and Go Test (TUG) were administered. In the E group, a significant decrease was observed in dominant and non-dominant DDPT times and TWT time, while a significant increase was observed in 6WWT distance (p<0.001). No significant change was observed in these parameters in the control group (p>0.05). In the intergroup comparison, the improvements in the Exercise Group were found to be statistically significantly more pronounced than in the control group (p<0.001). These findings indicate that an eight-week aerobic exercise programme has a positive effect on clinical progression markers in individuals with MS.
1 secondary outcome
Neurovascular unit biomarkers
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No. The primary reason for not sharing individual participant data (IPD) from this study is the need to ensure the highest level of data privacy and participant confidentiality. It was determined that the data could not be fully anonymized without leaving a potential risk of re-identification; therefore, IPD will not be shared. In addition, the study protocol and ethics committee approval do not include the sharing of individual-level data. However, summary-level results from the study may be shared with researchers upon reasonable request.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise intervention in people with Multiple Sclerosis, run by Lokman Hekim 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 8 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical progression (time frame: From enrollment to the end of treatment at 8 weeks). 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 8 Jan 2026.