Clinical trial NCT06676618: Effect of Multimodal Exercise Training in Patients With Multiple Sclerosis
Official title: Effect of Multimodal Exercise Training on Disease Activity and Functional Status in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Exercise
Physiotherapy
Degenerative diseases
Disease activity
Multimodal
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study aims to examine the effects of multimodal exercise training including aerobic, strengthening and balance exercises via face-to-face and asynchronous video-based telerehabilitation on disease activity, disability level, aerobic capacity, physical activity level, balance, fatigue level and quality of life in individuals with multiple sclerosis. Therefore, this study consists of two hypotheses.

Hypotheses:

H0: Multimodal exercise training has no effect on disease activity and functional status in patients with multiple sclerosis H1: Multimodal exercise training has effects on disease activity and functional status in patients with multiple sclerosis

Detailed description: Multiple sclerosis (MS) is a leading cause of disability in young adults, with symptoms varying based on lesion size, location, and disease course. These symptoms often worsen over time, significantly impacting quality of life. To manage symptoms and potentially affect disease activity, patients are often directed to exercise interventions, though the impact on disease progression is still being studied. Neuroimaging, particularly magnetic resonance imaging (MRI), is commonly used to monitor MS, but MRI does not reveal brain activation levels, which is why functional MRI is recommended for a more detailed evaluation. Exercise, both face-to-face and telerehabilitation (TR), is considered an effective treatment for MS. Studies show that TR increases patient adherence and can be as effective as in-person therapy. Our study aims to assess the effects of a multimodal exercise program combining face-to-face and TR on disease activity and functional status in patients with MS (PwMS). PwMS with an Expanded Disability Status Scale (EDSS) score of 3.0 to 5.5 will be randomly assigned to either the multimodal exercise training group (Group I) or a control group (Group II). Disease activity, disability, aerobic capacity, physical activity, balance, fatigue, and quality of life will be evaluated. Group I will participate in exercise training three days a week (one day in-person, two days TR) for 12 weeks. Group II will receive no exercise during this period and will be reassessed after 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with multiple sclerosis by a neurologist
* Volunteering to participate in the study
* Being ambulatory
* EDSS between 3.0-5.5
* Being literate
* Having internet access
* Not having participated in a standardized physiotherapy and rehabilitation program in the last 3 months

Exclusion Criteria:

* Having an orthopedic problem affecting its mobility
* Having psychiatric problems, severe cognitive impairment, or epilepsy in addition to the MS diagnosis
* Blurred vision or visual impairment
* Pregnancy
* Having had an attack or received corticosteroid treatment 3 months before participating in the study
* Having a disease affecting immunological parameters (infection, cancer, etc.)

Primary outcomes:
measure: Multiple Sclerosis Functional Composite Test (The change between the initial value and the value after 3 months will be evaluated).
timeFrame: Baseline and end of weeks 12
measure: Functional Magnetic Resonance Imaging (fMRI) (The change between the initial value and the value after 3 months will be evaluated).
timeFrame: Baseline and end of weeks 12
measure: Brain-derived neurotrophic factor (BDNF) assessment (The change between the initial value and the value after 3 months will be evaluated).
timeFrame: Baseline and end of weeks 12
Secondary outcomes:
measure: The Expanded Disability Status Scale (EDSS) (The change between the initial value and the value after 3 months will be evaluated).
timeFrame: Baseline and end of weeks 12
measure: 6 Minute Walk Test (6MWT) (The change between the initial value and the value after 3 months will be evaluated).
timeFrame: Baseline and end of weeks 12
measure: ActiGraph wGT3X-BT (The change between the initial value and the value after 3 months will be evaluated).
timeFrame: Baseline and end of weeks 12
measure: The Godin Leisure-Time Exercise Questionnaire (The change between the initial value and the value after 3 months will be evaluated).
timeFrame: Baseline and end of weeks 12
measure: Balance Assessment (The change between the initial value and the value after 3 months will be evaluated).
timeFrame: Baseline and end of weeks 12
measure: Fatigue Severity Scale (The change between the initial value and the value after 3 months will be evaluated).
timeFrame: Baseline and end of weeks 12
measure: Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) (The change between the initial value and the value after 3 months will be evaluated).
timeFrame: Baseline and end of weeks 12
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Buyukcekmece
Study officials:
affiliation: Istanbul University-Cerrahpasa Institute of Postgraduate Education
name: Pelin Vural, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University-Cerrahpasa Faculty of Health Science
name: Yonca Zenginler Yazgan, PhD
role: STUDY_CHAIR
affiliation: Istanbul University Istanbul Faculty of Medicine Department of Neurology
name: Murat Kürtüncü, Prof. Dr.
role: STUDY_CHAIR
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