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

NCT07202780 | Enrolling By Invitation

• 1 other identifier: Burcu3
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Breath Tests; MyotonPRO

Keywords

multiple skleroz; breath test; myoton pro

Outcome Measures

Primary Outcomes (7)

• Assessment of Neurological Disability Level:

  The neurological disability level of individuals with MS will be determined using the Expanded Disability Status Scale (EDSS), a widely used scale. Developed by Kurke, it has been the most commonly used method for measuring disability in the field of MS for many years. The EDSS is used to measure the level of disability in MS. The validity and reliability of the EDSS in Turkish, particularly when used in conjunction with other scales to comprehensively assess disability in the context of MS, has been demonstrated in various studies. The EDSS is a 20-stage disease severity scale ranging from 0 (normal) to 10 (death due to MS).

  1 year

• Fatigue Severity Scale

  The Fatigue Severity Scale (FSS) was first developed by Krupp et al. (1989). This scale was specifically designed to assess the severity of fatigue in patients with MS and other chronic conditions. Its validity and reliability in Turkish-speaking MS patients were demonstrated by Armutlu et al. (2007). The FSS consists of nine items that assess the impact of fatigue on daily functioning and overall quality of life, with responses measured on a seven-point Likert scale. In the self-administered version of the scale, each item is scored from 1 to 7 (1 = strongly disagree, 7 = strongly agree), and the total score is calculated as the average of the nine items. The lower the total score, the less fatigue is present. A commonly used cut-off value in clinical practice is a total score of 36 or higher, indicating significant fatigue.

  1 year

• The Hospital Anxiety and Depression Scale

  The Hospital Anxiety and Depression Scale (HADS) will be used to assess depression. Developed by Zigmond et al. (1983), this scale consists of 14 questions, seven measuring anxiety and seven measuring depression. A four-point Likert-type scale is used to answer each question. Each item is scored between 0 and 3, and the total score is calculated as the average of the seven items. The scale has been adapted into Turkish, and as a result of the validity and reliability study, the cut-off score for the anxiety subscale was found to be 10/11, and the cut-off score for the depression subscale was found to be 7/8. In our study, each HADS score for anxiety and depression will be considered as follows: 0-7 = normal, 8-10 = borderline abnormal, 11-21 = abnormal.

  1 year

• myoton pro

  The muscles of the patients' lower extremities, including the Rectus Femoris, Vastus Lateralis, Vastus Medialis, Biceps Femoris, Semitendinosus, Gastrocnemius Medialis, and Gastrocnemius Lateralis, as well as the auxiliary respiratory muscles, including the Sternocleidomastoideus, M. Upper Trapezius, M. Pectoralis Major, M. Serratus Anterior, M. Rectus Abdominis, and M. External Oblique Abdominis will be assessed using the MyotonPro® (Myoton AS, Estonia) digital palpation device.

  1 year

• Assessment of Lower Limb Functionality and Muscle Strength

  The 30-second sit-to-stand test (30s-OKT) will be used to measure lower limb functionality and muscle strength. The test, developed by Jones et al. (1999), is a functional assessment test. The 30sOKT has been validated as an effective measure of lower extremity strength, particularly in patients with MS, and has shown strong correlations with other functional assessments such as the Timed Up and Go (TUG) test and the 5-repetition sit-to-stand test (5STS). In our country, Özkeskin et al. (2023) applied this test to patients with MS and reported that the test-retest reliability was excellent (ICC \> 0.80) and the concurrent validity (r \> 0.05) was strong. Prior to the test, patients will rest for 30 minutes, and the physiotherapist administering the test will demonstrate how the test is performed to the patient. Patients will be seated upright on an armless chair (approximately 43 cm high) with their back against the wall, their

  1 years

• Assessment of Respiratory Muscle Strength:

  In clinical practice, respiratory muscle strength is assessed based on the principle of measuring the pressure difference between inspiration and expiration. Maximal voluntary inspiratory (PImax) and expiratory (PEmax) pressures (MIP and MEP) are the most commonly used non-invasive methods for measuring respiratory muscle strength (ATS/ERS, 2022). Black and Hyatt (1969) stated that this technique can be used for health checks in patients and athletes of all ages. Pressure is measured by performing maximal inspiration (Müller manoeuvre) and expiration (Valsalva manoeuvre) through the mouth. The manoeuvre is typically performed at residual volume (RV) for MIP and total lung capacity (TLC) for MEP (Cotes et al., 2006; Ruppel, 2009). In our study, patients' intraoral pressure measurements will be taken using a Cosmed Pony FX model device (Italy). Measurements were performed in a sitting position with a nose clip. The Valsalva and Müller manoeuvr

  1 year

• A Spirometry Test (SFT)

  involves the measurement of dynamic lung volumes and capacities over time during forced inspiration and expiration (Bartu-Saryal and Ulubay, 2012). In our study, SFT measurements will be performed using a Cosmed Pony FX model (Italy) portable spirometer. Patients will be informed about the PFT in advance, in accordance with measurement standards. To enable comparison with standard values, patients' gender, age, height, weight, and ethnicity (e.g., Caucasian) will be entered into the device. Tests will be performed in a seated position. At least 3 tests will be performed on each patient, and measurements will not be continued for cases that fail to perform the manoeuvre successfully after 8 tests. During the test, subjects will be asked to take 3-4 normal breaths and then take a deep inspiration, followed by a rapid and forceful expiration to expel all air (ATS/ERS, 2005). After three successful tests, the test with the highest sum of FVC and FEV1, as recommend

  1 years

Study Arms (2)

multiple sclerosis people

Individuals diagnosed with MS were included

healthy individuals

healthy individuals were included

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Having been diagnosed with MS according to the revised McDonald criteria followed at the Neurology Outpatient Clinic of Sanko University Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanko University: lead

Study Sites (1)

Sanko University

Gaziantep, şehitkamil, 27500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisant Prof.

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 2, 2025
• Study Start: January 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: April 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)