Investigation of Respiratory Muscle Sarcopenia in Patients With Systemic Sclerosis

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Respiratory Muscle Sarcopenia Assessment [Срок оценки: baseline]

Вторичные конечные точки (7)

• Grip Force Measurement [Срок оценки: baseline]
• 4 Meter Walking Speed Test (4MWT) [Срок оценки: baseline]
• Timed Up and Go Test (TUG) [Срок оценки: baseline]
• 5 Repetition Sit and Stand Test [Срок оценки: baseline]
• Respiratory muscle strength [Срок оценки: baseline]
• Demographic and Clinical Information [Срок оценки: baseline]
• Body composition [Срок оценки: baseline]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Turkey (Türkiye) · 1 центр

• Selcuk University — Konya

Публикации

• Sousa-Santos AR, Amaral TF. Differences in handgrip strength protocols to identify sarcopenia and frailty - a systematic review. BMC Geriatr. 2017 Oct 16;17(1):238. doi: 10.1186/s12877-017-0625-y. PMID 29037155
• Nagano A, Wakabayashi H, Maeda K, Kokura Y, Miyazaki S, Mori T, Fujiwara D. Respiratory Sarcopenia and Sarcopenic Respiratory Disability: Concepts, Diagnosis, and Treatment. J Nutr Health Aging. 2021;25(4):507-515. doi: 10.1007/s12603-021-1587-5. PMID 33786569
• Mehmet H, Robinson SR, Yang AWH. Assessment of Gait Speed in Older Adults. J Geriatr Phys Ther. 2020 Jan/Mar;43(1):42-52. doi: 10.1519/JPT.0000000000000224. PMID 30720555
• Maggio M, Ceda GP, Ticinesi A, De Vita F, Gelmini G, Costantino C, Meschi T, Kressig RW, Cesari M, Fabi M, Lauretani F. Instrumental and Non-Instrumental Evaluation of 4-Meter Walking Speed in Older Individuals. PLoS One. 2016 Apr 14;11(4):e0153583. doi: 10.1371/journal.pone.0153583. eCollection 2016. PMID 27077744
• Kera T, Kawai H, Hirano H, Kojima M, Watanabe Y, Motokawa K, Fujiwara Y, Ihara K, Kim H, Obuchi S. Definition of Respiratory Sarcopenia With Peak Expiratory Flow Rate. J Am Med Dir Assoc. 2019 Aug;20(8):1021-1025. doi: 10.1016/j.jamda.2018.12.013. Epub 2019 Feb 6. PMID 30737167
• Hulzebos E, Takken T, Reijneveld EA, Mulder MMG, Bongers BC. Reference Values for Respiratory Muscle Strength in Children and Adolescents. Respiration. 2018;95(4):235-243. doi: 10.1159/000485464. Epub 2018 Jan 17. PMID 29342462
• Greco F, Tarsitano MG, Cosco LF, Quinzi F, Folino K, Spadafora M, Afzal M, Segura-Garcia C, Maurotti S, Pujia R, Pujia A, Buono P, Emerenziani GP. The Effects of Online Home-Based Pilates Combined with Diet on Body Composition in Women Affected by Obesity: A Preliminary Study. Nutrients. 2024 Mar 21;16(6):902. doi: 10.3390/nu16060902. PMID 38542813
• Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. PMID 20392703

Идентификаторы

NCT: NCT06598982 · SelcukU-FTR-YG-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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