Investigation of Respiratory Muscle Sarcopenia in Patients with Systemic Sclerosis

Last updated: September 16, 2024
Sponsor: Selcuk University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sarcopenia

Scleroderma

Scar Tissue

Treatment

N/A

Clinical Study ID

NCT06598982
SelcukU-FTR-YG-02
  • Ages 18-75
  • All Genders

Study Summary

The aim of this study was to investigate respiratory muscle sarcopenia in individuals with systemic sclerosis. The main question it aims to answer is:

What is the prevalence of respiratory muscle sarcopenia in patients with systemic sclerosis? Participants body composition (bioelectrical impedance), hand grip strength (hand dynanometer), physical performance tests (5 repetition sit-and-stand test, 4-meter walk test, Timed up-and-go test) and respiratory muscle strength were evaluated.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Being between the ages of 18-75

  • 2013 To be diagnosed with systemic sclerosis according to ACR/EULAR classificationcriteria

  • Being clinically stable

  • Ability to adapt to tests (visual, cognitive, cooperative)

Exclusion

Exclusion Criteria:

  • Those with neurological and/or musculoskeletal problems that may affect the work

  • Presence of severe joint contracture or painful ulcers that may affect musclestrength measurement and walking

  • Presence of severe infection or sepsis

  • Being diagnosed with a known additional rheumatologic disease

  • Any stage of cancer

  • Pregnant or breastfeeding

Study Design

Total Participants: 85
Study Start date:
July 01, 2024
Estimated Completion Date:
July 01, 2025

Study Description

Sarcopenia is a generalized and progressive loss of skeletal muscles and is characterized by a decrease in muscle strength, muscle mass and physical performance. It usually occurs in older people, but can also occur in people with certain diseases or who lead a very sedentary lifestyle. The European Working Group on Sarcopenia in Older People (EWGSOP) has developed guidelines for diagnosing sarcopenia and determining its severity. EWGSOP defined three conceptual stages of sarcopenia. Pre-sarcopenia is characterized by low muscle mass that does not affect muscle strength or physical performance. Sarcopenia is characterized by low muscle mass and decreased muscle strength or reduced physical performance. Severe sarcopenia is characterized when all criteria are met. Respiratory muscle sarcopenia is defined as a condition of muscle fiber atrophy and weakness that also occurs in respiratory muscles. The Japanese Respiratory Sarcopenia Study Group defined respiratory muscle sarcopenia as "whole body sarcopenia and low respiratory muscle mass with low respiratory muscle strength and/or low respiratory function". Respiratory muscle sarcopenia was also defined by Kera et al. based on peak expiratory flow rate. However, whole body sarcopenia and respiratory muscle strength are also important to define and diagnose respiratory muscle sarcopenia. The incidence of respiratory muscle sarcopenia is higher in the presence of sarcopenia. Sarcopenic respiratory failure is diagnosed when there is sarcopenia with functional impairment. Cases of respiratory sarcopenia without functional impairment are diagnosed as "at risk of sarcopenic respiratory failure". When the literature is reviewed, it is seen that there is no study on respiratory muscle sarcopenia in patients with systemic sclerosis. Therefore, the aim of this study is to examine respiratory muscle sarcopenia in patients with systemic sclerosis.

The smallest sample size of the study was 85 people with 90% power at 95% confidence interval. Data will be analyzed using IBM® SPSS® Statistics for Windows (ver. 25.0; IBM Corp, New York, USA) software. Values will be expressed as mean ± standard deviation and median (25-75 quartiles) for continuous variables and frequencies will be reported for categorical variables. Shapiro-Wilk test and histograms will be used to assess the normality distribution of the data. Pearson correlation coefficient will be used to evaluate the parameters associated with respiratory muscle strength. Binary Logistic Regression Analysis, which is used to estimate whether the dependent variable belongs to two categorical classes, will be used to determine the risk factors for respiratory muscle sarcopenia.

Connect with a study center

  • Selcuk University

    Konya, Selcuklu 42250
    Turkey

    Active - Recruiting

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