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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06721416
Enrollment
12
Registered
2024-12-06
Start date
2024-12-01
Completion date
2025-08-30
Last updated
2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

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

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.

Interventions

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

OTHERVR 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.

OTHERConventional Exercise

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

Sponsors

Acibadem University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Energy SpentFor 30 minutes during the entire exerciseSense 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.
Cortical ActivityDuring preintervention cognitive tasks, for 30 minutes during the entire exercise, during postintervention cognitive tasksFunctional 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.
Body Temperatureimmediately before the exercise, immediately after the exerciseIndividuals' body temperatures will be measured with the help of an electronic digital thermometer before and after the exercises.
Electrodermal ActivityDuring preintervention cognitive tasks, for 30 minutes during the entire exercise, during postintervention cognitive tasksElectrodermal activity data will be recorded with the Shimmer device to be used to determine the stress levels of the patients.
Cognitive FunctionImmediately before the exercise, immediately after the exerciseStroop test will be used to compare the cognitive performances of the patients before and after exercise and to comment on cognitive fatigue after exercise.
Physical FatigueImmediately after the exerciseModified 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.
Satisfaction Level satisfaction level Satisfaction LevelImmediately after the exerciseIt 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.
Late-term fatigue24 hours later after the exerciseOne 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026