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NCT Number: NCT07152015

Multiple Sclerosis, Sarcopenia and Respiration

The goal of this observational study is to evaluate the relationship between respiratory function and sarcopenia in people with multiple sclerosis.

The main questions it aims to answer are:

Is there a relationship between muscle structure and respiratory muscle strength/pulmonary function in MS patients?

Undergo a single session of respiratory muscle strength measurement (e.g., maximal inspiratory pressure [MIP], maximal expiratory pressure [MEP]) Perform spirometry to assess pulmonary function

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uskudar University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being diagnosed with MS by a neurologist
  • Being diagnosed with Sarcopenia
  • No history of attacks in the last 3 months
  • Able to walk with and without support (EDSS<6.5)

Exclusion criteria

  • Having concomitant lung and heart disease
  • Mini Mental score below 24
  • Being in pregnancy

Treatment and study plan

Primary outcomes

  1. Forced Vital Capacity

    Time frame: 1 day (The evaluation will be done one-time)

    FVC, defined as the total volume of air that can be forcibly exhaled after full inspiration, will be recorded with spirometry using the Cosmed Pony FX device, following ATS guidelines.

  2. Forced Expiratory Volume in 1 second (FEV1)

    Time frame: 1 day (The evaluation will be done one-time)

    FEV1, spirometric evaluation of the maximum volume of air exhaled in the first second of a forced breath, will be measured using the Cosmed Pony FX device (Rome, Italy) in accordance with ATS standards.

  3. FEV1/FVC Ratio (%)

    Time frame: 1 day (The evaluation will be done one-time)

    The ratio of FEV1 to FVC (FEV1/FVC) will be obtained as an index of airflow limitation. This ratio will be calculated from spirometry values measured with the Cosmed Pony FX device under ATS standards.

  4. Maximal Inspiratory Pressure

    Time frame: 1 day (The evaluation will be done one-time)

    MIP, reflecting inspiratory muscle strength, will be assessed through maximal inspiratory efforts against a closed airway, using the Cosmed Pony FX device according to ATS recommendations.

  5. Maximal Expiratory Pressure

    Time frame: 1 day (The evaluation will be done one-time)

    MEP, representing expiratory muscle strength, will be determined by maximal expiratory efforts against a closed airway. Measurements will be obtained with the Cosmed Pony FX device (Rome, Italy) according to ATS standards

Secondary outcomes

  1. and grip strength measurement

    Time frame: 1 day (The evaluation will be done one-time)

    Muscle strength assessment will do by measuring handgrip strength. The measurement is performed with the JAMAR hand dynamometer upon the recommendation of the American Hand Therapists Association.

  2. Skeletal Muscle Index (SMI, kg/m²)

    Time frame: 1 day (The evaluation will be done one-time)

    Skeletal Muscle Index (SMI) will be assessed using bioelectrical impedance analysis (BIA). SMI will be calculated as appendicular skeletal muscle mass (kg) divided by height squared (m²). Measurements will be performed once at baseline under standard BIA testing conditions.

Sponsors and collaborators

Lead sponsor

Uskudar University

Other

Registry information

Official study title

Examination of Sarcopenia and Respiratory Functions in Multiple Sclerosis

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 3, 2025
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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