An interventional study of aerobic exercise intervention in Multiple Sclerosis, sponsored by Lokman Hekim University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Lokman Hekim University · Not applicable, Interventional, and Treatment
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).
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
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Exclusion Criteria:
Criteria for exclusion from the study:
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).
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.
Other: aerobic exercise intervention
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.
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.
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Time frame: From enrollment to the end of treatment at 8 weeks
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Plan to share: 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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Lokman Hekim University