NCT06676618

Effect of Multimodal Exercise Training in Patients With Multiple Sclerosis

Effect of Multimodal Exercise Training on Disease Activity and Functional Status in Patients With Multiple Sclerosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Istanbul University - Cerrahpasa · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Multimodal Exercise Training	The exercise training consisting of aerobic, strengthening and balance exercises will be applied for 12 weeks/3days for 1hour. One day of the exercise training will be performed in a clinical environment with a physiotherapist, and the other 2 days of the week, participants will be asked to apply asynchronous video-based telerehabilitation over the internet in their own homes. The asynchronous video-based telerehabilitation application will be performed through an account created specifically for the participant on the "www.telenororehab.com" website. The exercise program will be created according to the individual's condition and progression will be provided every 3 weeks. Patients who do not attend 3 consecutive sessions will be excluded from the study.
OTHER	Control Group	Participants in the control group will be placed on the waiting list after all evaluation methods have been applied and will be re-evaluated at the end of 12 weeks.

Timeline

• Start date: 2025-02-10
• Primary completion: 2027-05-01
• Completion: 2028-05-01
• First posted: 2024-11-06
• Last updated: 2026-03-17

Locations

2 sites across 1 country: Turkey (Türkiye)