Effect of Combined Exercise Training in Patients With Multiple Sclerosis

NCT ID: NCT06595394

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2025-02-28

Brief Summary

The aim of this clinical trial is exercise in sarcopenic MS patients to demonstrate the effectiveness of education. The main questions it aims to answer are: -Can exercise training make a change in muscle thickness in sarcopenic MS patients?

--Does exercise training have an effect on balance in sarcopenic MS patients?

• Does exercise training have an effect on the risk of falling in sarcopenic MS patients?

Participants will:

They will continue combined exercise applications 3 days a week for 8 weeks. Evaluations will be made before the application and at the end of the 8 weeks. The data will be analyzed afterwards.

Detailed Description

A significant decrease in physical performance is observed in MS patients. The reasons for this can be changes in muscle contractile structures and symptoms such as sarcopenia. Sarcopenia is a disorder characterized by loss of skeletal muscle mass and decrease in muscle strength and physical performance. Loss of muscle mass seen outside of old age is defined as secondary sarcopenia. In recent years, studies on neurological disorders and their relationship with sarcopenia have increased. Early diagnosis of sarcopenia in neurological patients and implementation of applications aimed at this are important from an early stage. The aim of this study is to examine the effect of exercise training in sarcopenic MS patients. In the study, participants will be applied a combined exercise program 3 days a week for 8 weeks. Parameters such as muscle thickness, balance, and fall risk will be evaluated before and after physiotherapy application including aerobic exercise, balance exercises, and strengthening exercises.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Interventional group

Participants were given combined exercise training 3 days a week.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

Participants in the experimental group will receive treatment for 8 weeks, 3 sessions per week. Each treatment session will be planned to last 60 minutes. People in the experimental group will receive a combined exercise training consisting of aerobic exercise, balance exercise and strengthening exercises for 8 weeks.

Control group

Participants were followed with a home program 3 days a week.

Group Type: ACTIVE_COMPARATOR

Home program

Intervention Type: OTHER

The control group will be followed with a home program for 8 weeks. Patients will be asked to apply the home program, which includes traditional physiotherapy practices, 3 days a week and this will be followed by physiotherapists.

Interventions

Exercise

Participants in the experimental group will receive treatment for 8 weeks, 3 sessions per week. Each treatment session will be planned to last 60 minutes. People in the experimental group will receive a combined exercise training consisting of aerobic exercise, balance exercise and strengthening exercises for 8 weeks.

Intervention Type: OTHER

Home program

The control group will be followed with a home program for 8 weeks. Patients will be asked to apply the home program, which includes traditional physiotherapy practices, 3 days a week and this will be followed by physiotherapists.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• People diagnosed with MS by a neurologist
• People with ambulation whose EDSS is 4.5 or below
• People between the ages of 18-50
• People who do not exercise regularly and are not included in an exercise program

Exclusion Criteria

• Having been diagnosed with sarcopenia before MS diagnosis
• Having had an MS attack within the last 30 days
• Having any musculoskeletal problems that may affect walking and balance
• Having a diagnosed psychiatric disease that may affect cognitive status
• Having a neurological disease other than MS

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uskudar University

OTHER

Sponsor Role: lead

Responsible Party

tuba kolaylı

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sibel Aksu Yıldırım, Prof.

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Central Contacts

Tuba Kolaylı, MSc.

Role: CONTACT

tuba.kolayli@uskudar.edu.tr

2164002222

Other Identifiers

sarcopenicms11

Identifier Type: -

Identifier Source: org_study_id