The Relationship Between Mechanical Properties of Respiratory and Lower Extremity Muscles and Other Parameters in Multiple Sclerosis

NCT ID: NCT07202780

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 58 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-04-01

Brief Summary

Multiple sclerosis (MS) is a chronic inflammatory disease characterised by deterioration in the mechanics of the lower extremities and respiratory muscles and a decrease in respiratory function. Fatigue and depression are among the most common symptoms. The aim of this study is to investigate the potential effect of the mechanical properties of the lower extremity and respiratory muscles on respiratory function, fatigue, and anxiety-depression. The sample will consist of 29 MS patients who meet the inclusion and exclusion criteria and volunteer to participate in the study. The sociodemographic data of the individuals will be recorded. Subsequently, the Pulmonary Dysfunction Index (PDI), Modified Medical Research Council Scale (mMRC), Expanded Disability Status Scale (EDSS), Fatigue Severity Scale (FSS), and Hospital Anxiety and Depression Scale (HADS) will be administered to the individuals. The mechanical properties of the accessory respiratory and lower extremity muscles will be recorded using a digital palpation device, and respiratory function and respiratory muscle strength values will be recorded using a portable spirometer. Lower extremity function and strength will be assessed using the 30-second sit-to-stand test. At the end of the study, the level of association between the mechanical properties of the auxiliary respiratory and lower extremity muscles and respiratory function, respiratory muscle strength, fatigue, and depression will be evaluated. The SPSS software package will be used for data analysis. A significance level of p˂0.05 will be accepted. Furthermore, this study will determine the relationship between the mechanical properties of respiratory and lower extremity muscles in MS and provide a different perspective on the clinical management of the disease.

Detailed Description

Multiple sclerosis (MS) is a chronic inflammatory disease characterised by demyelination and axonal degeneration in the central nervous system, leading to various motor and sensory impairments. Symptoms are classified as cognitive, sensory, and motor, with the most common symptoms including loss of muscle control, muscle weakness, abnormal muscle tone, ataxia, depression, and fatigue. These impairments frequently affect balance and gait, leading to the disabling consequences of the disease. The muscle groups most affected in individuals with MS are the lower extremities, which exhibit significant reductions in muscle strength and function. Research shows that in the early stages of MS, muscle strength in the lower extremities can decrease by approximately 25% compared to healthy controls, with marked deficiencies in muscle activation and increased fatigue. Studies have shown that quadriceps strength is significantly reduced, which can lead to difficulties in walking and maintaining balance. Furthermore, in MS patients, the coactivation patterns of lower limb muscles during walking change, indicating a compensatory mechanism in response to decreased muscle strength. This coactivation can lead to inefficient movement patterns, further exacerbating fatigue and functional limitations.

Fatigue is another important symptom associated with MS and affects both voluntary and involuntary muscle contractions. Approximately 65% of individuals with MS report fatigue, and 40% describe fatigue as the most disabling symptom. However, despite the prevalence of fatigue in MS, its exact mechanisms remain unclear. It has been suggested that there may be a correlation between fatigue and increased central arousal to compensate for reduced central activation, and depression has also been reported as a factor that increases fatigue. Fatigue is not only a result of muscle weakness but also involves central mechanisms that impair motor control and muscle activation.

Disability in MS is associated with reduced mobility, abnormal gait mechanics, impaired balance and muscle weakness, as well as cognitive and autonomic dysfunction. These impairments typically reduce functional capacity, increase fatigue, reduce independence in activities of daily living, and consequently increase the risk of secondary diseases such as coronary heart disease, diabetes, and obesity. Therefore, a good understanding of fatigue and the mechanical properties of muscle in these patients may play an important role in disease progression.

MS can affect the trunk and respiratory muscles as well as the lower extremities. Factors affecting respiratory function include muscle weakness, changes in muscle tone, motor coordination disorders, and postural abnormalities. In addition, MS can affect the centres responsible for respiratory function, leading to clinically significant changes in respiratory control. It has been reported that respiratory muscle weakness can be observed even in the early stages of MS. These studies highlight the complex effect of MS on respiratory function and respiratory muscle weakness.

In summary, MS is a multi-faceted disease that can affect the muscles of the lower extremities, particularly the quadriceps, as well as the trunk and respiratory muscles. These impairments can lead to significant functional limitations, affecting the mobility and overall quality of life of individuals with MS and potentially worsening the progression of the disease. Therefore, it is important to understand this condition well and take it into account in clinical management. However, lower limb and respiratory muscle mechanics, respiratory function, fatigue, and depression levels in individuals with MS have not been comprehensively investigated. Therefore, the aim of this study is to investigate the potential relationship between lower limb and respiratory muscle mechanics, respiratory function, fatigue, and anxiety-depression in individuals with MS.

Research Hypotheses:

H0: The mechanical properties of the respiratory and lower extremity muscles in individuals with multiple sclerosis have no effect on respiratory function, fatigue, and depression levels.

H1: The mechanical properties of the respiratory and lower extremity muscles in individuals with multiple sclerosis have an effect on respiratory function, fatigue, and depression levels.

This study will be conducted jointly by the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, SANKO University, and the Department of Neurology, Faculty of Medicine, SANKO University. MS patients who apply to the Neurology Outpatient Clinic of SANKO University Hospital and meet the inclusion criteria will be included in the study. Patients included in the study will be evaluated at the SANKO University Department of Physiotherapy and Rehabilitation Research Laboratory.

The study data were collected using the Case Report Form (CRF), Pulmonary Dysfunction Index (PDI), Modified Medical Research Council Scale (mMRC), Expanded Disability Status Scale (EDSS), Fatigue Severity Scale (FSS), and Hospital Anxiety and Depression Scale (HADS). Data contained in the Data Collection Form (DCF) will be obtained using the 30-second sit-to-stand functional assessment test (30sSTT) and laboratory measurement devices including the MyotonPro® digital palpation device (Myoton AS, Estonia) and a portable spirometer (Cosmed, Pony Fx, Rome, Italy).

The study data were collected using the Case Report Form (CRF), Pulmonary Dysfunction Index (PDI), Modified Medical Research Council Scale (mMRC), Expanded Disability Status Scale (EDSS), Fatigue Severity Scale (FSS), and Hospital Anxiety and Depression Scale (HADS). Data contained in the Data Collection Form (DCF) will be obtained using the 30-second sit-to-stand functional assessment test (30sSTT) and laboratory measurement devices including the MyotonPro® digital palpation device (Myoton AS, Estonia) and a portable spirometer (Cosmed, Pony Fx, Rome, Italy).

Healthy individuals of the same age group will be included in the study. The results of healthy individuals will be compared with the results of MS patients.

Conditions

Multiple Sclerosis; Breath Tests; MyotonPRO

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

multiple sclerosis people

Individuals diagnosed with MS were included

No interventions assigned to this group

healthy individuals

healthy individuals were included

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Having been diagnosed with MS according to the revised McDonald criteria followed at the Neurology Outpatient Clinic of Sanko University Hospital,
• Being between 18 and 50 years of age,
• Not having had an attack in the last 6 months,
• Having an EDSS score of 4.5 or below,
• To have given consent for the study.

Exclusion Criteria

History of lower extremity surgery within the last 12 months,

• To have undergone physiotherapy within the last 6 months,
• Presence of current trauma or fracture involving the lower extremities,
• Presence of another neuro-musculoskeletal or pulmonary disease besides MS,
• Inability to cooperate with measurements and demonstrate compliance,
• Having received pulse steroid therapy or botulinum toxin/phenol injection within the last 6 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanko University

OTHER

Sponsor Role: lead

Responsible Party

Burcu Bağcı

Assisant Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sanko University

Gaziantep, şehitkamil, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Burcu3

Identifier Type: -

Identifier Source: org_study_id