Clinical trial NCT06598982: Investigation of Respiratory Muscle Sarcopenia in Patients with Systemic Sclerosis
Official title: Investigation of Respiratory Muscle Sarcopenia in Patients with Systemic Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Sclerosis (SSc)
Scleroderma
Keywords: respiration
sarcopenia
diaphragm
muscle strength
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted at Selçuk University, Faculty of Health Sciences. The study will include volunteer individuals with systemic sclerosis who are eligible to participate in the study and who are being followed up and treated with a diagnosis of scleroderma in the Department of Rheumatology.

-- Purposive sampling

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-75
* 2013 To be diagnosed with systemic sclerosis according to ACR/EULAR classification criteria
* Being clinically stable
* Ability to adapt to tests (visual, cognitive, cooperative)

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 muscle strength measurement and walking
* Presence of severe infection or sepsis
* Being diagnosed with a known additional rheumatologic disease
* Any stage of cancer
* Pregnant or breastfeeding

Primary outcomes:
measure: Respiratory Muscle Sarcopenia Assessment
timeFrame: baseline
Secondary outcomes:
measure: Grip Force Measurement
timeFrame: baseline
measure: 4 Meter Walking Speed Test (4MWT)
timeFrame: baseline
measure: Timed Up and Go Test (TUG)
timeFrame: baseline
measure: 5 Repetition Sit and Stand Test
timeFrame: baseline
measure: Respiratory muscle strength
timeFrame: baseline
measure: Demographic and Clinical Information
timeFrame: baseline
measure: Body composition
timeFrame: baseline
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
Study officials:
References:
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