Effect of Multimodal Exercise Training in Patients With Multiple Sclerosis (PwMS)

Istanbul University - Cerrahpasa (IUC)

Status: Not yet enrolling

Conditions: Multiple Sclerosis

Treatments: Other: Control Group; Other: Multimodal Exercise Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06676618

IU-C20204-161

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Multimodal Exercise Training Group

Experimental group

Description:

Participants in the multimodal exercise training group will be given a treatment protocol consisting of aerobic exercise and strengthening exercises in the presence of a physiotherapist for a total of 12 weeks, 3 days a week for 1 hour.

Treatment:

Other: Multimodal Exercise Training

Control Group

Other group

Description:

Participants in the control group will be put on the waiting list after all assessment methods have been applied and will be re-evaluated at the end of 12 weeks.

Treatment:

Other: Control Group