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

NCT06721416 | Completed

• 1 other identifier: 2023-07/229
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; aerobic exercise; virtual reality; fatigue; cognition

Outcome Measures

Primary Outcomes (10)

• Energy Spent

  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

  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

  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

  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

  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

  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

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

  Immediately after the exercise

• Physical Fatigue

  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

  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

  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

Study Arms (3)

Virtual Reality Beased

EXPERIMENTAL

VR based aerobic exercise

Other: VR Based Aerobic Exercise

Traditional

EXPERIMENTAL

Cycling ergometer based aerobic exercise

Other: Traditional Aerobic Exercise

Conventional

EXPERIMENTAL

Conventional physical therapy approaches

Other: Conventional Exercise

Interventions

Traditional Aerobic Exercise OTHER

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

Traditional

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.

Virtual Reality Beased

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.

Conventional

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed as Relapsing Remitting MS by neurologist according to the McDonald Criteria.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem University

Ataşehir, Istanbul, 34758, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

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

Study Officials

• Merve Sevik Dönderici, MSc

  Acibadem University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: December 1, 2024
• Primary Completion: July 30, 2025
• Study Completion: August 30, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

TU (1)