Comparing the Acute Effects of Different Exercise Approaches in Patients With Multiple Sclerosis

September 11, 2025 updated by: Merve Sevik Dönderici, Acibadem University

Comparing the Acute Effects and Cortical Hemodynamic Response of Different Exercise Approaches in Patients With Multiple Sclerosis: fNIRS Study

Multiple Sclerosis (MS) is the second most common neurological disorder in young adults after trauma. Treatments developed today can slow progression and reduce symptoms. Exercise therapy is a useful rehabilitation practice in MS to manage symptoms, restore function, optimize quality of life, ensure well-being and increase participation in daily life activities. In this study, it is planned to investigate the acute effects of conservative and virtual reality (VR)-based aerobic exercise applications and standard exercises that frequently form the rehabilitation programs of individuals with MS in clinics. For this purpose, patients with MS who met the inclusion criteria were given two-week intervals; Conservative aerobic exercise, virtual reality-based aerobic exercise and standard exercise practices will be performed. With the data obtained from this study, it is aimed to investigate the safety of aerobic exercises performed using VR tools that can be used in telerehabilitation applications, which are thought to have a very important place in MS rehabilitation in the future, in terms of acute body temperature increase, cognitive and physical fatigue caused by conservative methods and fNIRS cortical effects of VR-based aerobic exercise applications. It will be possible to prove it with objective methods such as.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Ataşehir, Istanbul, Turkey (Türkiye), 34758
        • Acibadem University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed as Relapsing Remitting MS by neurologist according to the McDonald Criteria.
  • 18-55 years old.
  • EDSS score < 4.5
  • Mini mental examination test score ≥ 24
  • No MS attack in the last 6 months.
  • No visual or vestibular deficits.
  • Signed the written consent form.

Exclusion Criteria:

  • Having previous full immersive VR experience.
  • Having an additional neurological disease.
  • Spasticity in any muscle of the upper extremity > 3, according to MAS.
  • Continuing the active physical therapy and rehabilitation program.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Beased
VR based aerobic exercise
Other: VR Based Aerobic Exercise
In the virtual reality-based aerobic exercise training, the game called "Beat Saber" will be played with Oculus Quest 2 virtual reality for 30 minutes.
Experimental: Traditional
Cycling ergometer based aerobic exercise
Other: Traditional Aerobic Exercise
Traditional aerobic exercise will be continued with an arm ergometer, at moderate intensity, for 30 minutes.
Experimental: Conventional
Conventional physical therapy approaches
Other: Conventional Exercise
The conventional exercise program will be modified with stabilization, balance and strengthening exercises, taking into account the functional status of the participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy Spent
Time Frame: For 30 minutes during the entire exercise
Sense Wear Pro3 Armband by Body Media Inc. (USA): It will be used to calculate the energy spent during exercises. This device is a 2-axis monitor with multiple sensors such as a galvanic skin response sensor to evaluate skin electrical resistance changes and a skin temperature sensor to evaluate temperature changes. The device will be worn on the individuals' right arm triceps muscle throughout the exercises and will be used to calculate the energy spent during the exercises.
For 30 minutes during the entire exercise
Cortical Activity
Time Frame: During preintervention cognitive tasks, for 30 minutes during the entire exercise, during postintervention cognitive tasks
Functional Near Infrared Light Spectroscopy (fNIRS): fNIRS is an optical system that uses near-infrared (NIR) light in the assessment of brain activity by measuring light absorption differences in changes in oxy-hemoglobin and deoxy-hemoglobin concentrations. The modified Beer-Lambert law is used to convert and calculate light intensity measurements obtained from the brain into hemodynamic changes. Hemodynamic responses that occur with different stimuli in the prefrontal cortex region of the brain can be monitored with these optical systems. In this study, it is planned to measure individuals' prefrontal cortex activations while performing 3 different exercises and a post-exercise cognitive performance test.
During preintervention cognitive tasks, for 30 minutes during the entire exercise, during postintervention cognitive tasks
Body Temperature
Time Frame: immediately before the exercise, immediately after the exercise
Individuals' body temperatures will be measured with the help of an electronic digital thermometer before and after the exercises.
immediately before the exercise, immediately after the exercise
Electrodermal Activity
Time Frame: During preintervention cognitive tasks, for 30 minutes during the entire exercise, during postintervention cognitive tasks
Electrodermal activity data will be recorded with the Shimmer device to be used to determine the stress levels of the patients.
During preintervention cognitive tasks, for 30 minutes during the entire exercise, during postintervention cognitive tasks
Cognitive Function
Time Frame: Immediately before the exercise, immediately after the exercise
Stroop test will be used to compare the cognitive performances of the patients before and after exercise and to comment on cognitive fatigue after exercise.
Immediately before the exercise, immediately after the exercise
Cognitive Function
Time Frame: Immediately before the exercise, immediately after the exercise
2-back test will be used to compare the cognitive performances of the patients before and after exercise and to comment on cognitive fatigue after exercise.
Immediately before the exercise, immediately after the exercise
Cognitive Function
Time Frame: Immediately after the exercise
Symbol Digit Modalities Test will be used after the exercise to evaluate cognitive performance.
Immediately after the exercise
Physical Fatigue
Time Frame: Immediately after the exercise
Modified Borg Scale will be used after the exercise to evaluate subjective physical fatigue. The values of this scale range from 0 to 10. While 0 means I have no fatigue, 10 indicates the most severe fatigue.
Immediately after the exercise
Satisfaction Level satisfaction level Satisfaction Level
Time Frame: Immediately after the exercise
It will be evaluated with the Satisfaction Evaluation Survey of Virtual Rehabilitation Systems. The total score range in this survey varies between 6-30, with higher scores being associated with higher satisfaction.
Immediately after the exercise
Late-term fatigue
Time Frame: 24 hours later after the exercise
One day after the exercises, patients will be questioned by phone about whether they have arm pain, and in case of pain, they will be asked to score the severity of pain according to Modified Borg Scale. The values of this scale range from 0 to 10. While 0 means I have no fatigue, 10 indicates the most severe fatigue.
24 hours later after the exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Investigators

  • Principal Investigator: Merve Sevik Dönderici, MSc, Acibadem University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Actual)

July 30, 2025

Study Completion (Actual)

August 30, 2025

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Actual)

December 6, 2024

Study Record Updates

Last Update Posted (Estimated)

September 17, 2025

Last Update Submitted That Met QC Criteria

September 11, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-07/229

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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