Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598982
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Investigation of Respiratory Muscle Sarcopenia in Patients with Systemic Sclerosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigation of Respiratory Muscle Sarcopenia in Patients with Systemic Sclerosis
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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 250 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
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 250 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None