Clinical trial NCT06721416: Comparing the Acute Effects of Different Exercise Approaches in Patients with Multiple Sclerosis
Official title: Comparing the Acute Effects and Cortical Hemodynamic Response of Different Exercise Approaches in Patients with Multiple Sclerosis: FNIRS Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
aerobic exercise
virtual reality
fatigue
cognition
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Energy Spent
timeFrame: For 30 minutes during the entire exercise
measure: Cortical Activity
timeFrame: During preintervention cognitive tasks, for 30 minutes during the entire exercise, during postintervention cognitive tasks
measure: Body Temperature
timeFrame: immediately before the exercise, immediately after the exercise
measure: Electrodermal Activity
timeFrame: During preintervention cognitive tasks, for 30 minutes during the entire exercise, during postintervention cognitive tasks
measure: Cognitive Function
timeFrame: Immediately before the exercise, immediately after the exercise
measure: Cognitive Function
timeFrame: Immediately before the exercise, immediately after the exercise
measure: Cognitive Function
timeFrame: Immediately after the exercise
measure: Physical Fatigue
timeFrame: Immediately after the exercise
measure: Satisfaction Level satisfaction level Satisfaction Level
timeFrame: Immediately after the exercise
measure: Late-term fatigue
timeFrame: 24 hours later after the exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Ataşehir
country: Turkey
facility: Acibadem University
state: İstanbul
Study officials:
affiliation: Acibadem University
name: Merve Sevik Dönderici, MSc
role: PRINCIPAL_INVESTIGATOR
References: