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

NCT07325019 | Completed

• 1 other identifier: 2024313
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Sclerosis

Keywords

Aerobic Exercise; Neurovascular Unit; Multiple Sclerosis; Biomarker; Clinical Progression

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (1)

• Neurovascular unit biomarkers

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

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.

Other: aerobic exercise intervention

Interventions

aerobic exercise intervention 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.

aerobic exercise

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Lokman Hekim University: lead

Study Sites (1)

Lokman Hekim University

Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Disease Progression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Advanced Physiotherapist

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 8, 2026
• Study Start: February 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)