THE EFFECTS OF AEROBİC EXERCİSE ON NEUROVASCULAR UNİT AND CLİNİCAL PROGRESSİON MARKERS İN INDİVİDUALS WİTH MULTİPLE SCLEROSİS

NCT ID: NCT07325019

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-06-30

Brief 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. 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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

control

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

aerobic exercise

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.

Group Type: ACTIVE_COMPARATOR

aerobic exercise intervention

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lokman Hekim University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Elif Asan

Advanced Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lokman Hekim University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2024313

Identifier Type: -

Identifier Source: org_study_id