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NCT Number: NCT06721416

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Acibadem University

Ataşehir, Istanbul, 34758, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Traditional Aerobic Exercise

Other

Traditional aerobic exercise will be continued with an arm ergometer, at moderate intensity, for 30 minutes.

VR Based Aerobic Exercise

Other

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.

Conventional Exercise

Other

The conventional exercise program will be modified with stabilization, balance and strengthening exercises, taking into account the functional status of the participants.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Cognitive Function

    Time frame: Immediately after the exercise

    Symbol Digit Modalities Test will be used after the exercise to evaluate cognitive performance.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2024
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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