Effect of Combined Exercise Training in Patients With Multiple Sclerosis

NCT06595394 | Not Yet Recruiting

• 1 other identifier: sarcopenicms11
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Keywords

Sarcopenia; Exercise

Outcome Measures

Primary Outcomes (1)

• Muscle thickness

  Ultrasound (US) is an easy-to-use imaging method that provides information about both muscle quality and quantity, with no risk of radiation. Muscle thickness will be assessed with US. Muscle thickness assessed with US has been shown to be consistent with gold standard measurements that assess muscle function and thickness.

  8 weeks

Secondary Outcomes (7)

• SARC -F

  8 weeks

• Hand grip strength measurement

  8 weeks

• Bioelectrical impedance analysis

  8 weeks

• Timed Up and Go (TUG)

  8 weeks

• Berg Balance Scale (BBS)

  8 weeks

Study Arms (2)

Interventional group

EXPERIMENTAL

Participants were given combined exercise training 3 days a week.

Other: Exercise

Control group

ACTIVE COMPARATOR

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

Other: Home program

Interventions

Exercise 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.

Interventional group

Home program 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.

Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uskudar University: lead

MeSH Terms

Conditions

Multiple Sclerosis; Sarcopenia; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sibel Aksu Yıldırım, Prof.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuba Kolaylı, MSc.

CONTACT

2164002222; tuba.kolayli@uskudar.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share