Effect of Multimodal Exercise Training in Patients With Multiple Sclerosis

NCT ID: NCT06676618

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2027-04-01

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Multimodal Exercise Training Group

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.

Group Type: EXPERIMENTAL

Multimodal Exercise Training

Intervention Type: OTHER

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.

Control Group

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.

Group Type: OTHER

Control Group

Intervention Type: OTHER

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. After the evaluations, individuals in the control group will also be given multimodal exercise training.

Interventions

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.

Intervention Type: 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. After the evaluations, individuals in the control group will also be given multimodal exercise training.

Intervention Type: OTHER

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.)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Pelin Vural

Lecturer, Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pelin Vural, MSc

Role: PRINCIPAL_INVESTIGATOR

Istanbul University-Cerrahpasa Institute of Postgraduate Education

Yonca Zenginler Yazgan, PhD

Role: STUDY_CHAIR

Istanbul University-Cerrahpasa Faculty of Health Science

Murat Kürtüncü, Prof. Dr.

Role: STUDY_CHAIR

Istanbul University Istanbul Faculty of Medicine Department of Neurology

Locations

Istanbul University-Cerrahpasa

Istanbul, Buyukcekmece, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Pelin Vural, MSc

Role: CONTACT

pelinvural7@gmail.com

+905344245350

Facility Contacts

Pelin Vural

Role: primary

pelinvural7@gmail.com

+905344245350

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Other Identifiers

IU-C20204-161

Identifier Type: -

Identifier Source: org_study_id