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临床试验/NCT07178197
NCT07178197已完成不适用

Association of Sarcopenia With Quality of Life and Progression of Disease in Patients With Idiopathic Pulmonary Fibrosis

Mersin University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年12月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Hand Grip Strength

研究概览

简要总结

Sarcopenia negatively affects the prognosis of chronic diseases. However, the importance of sarcopenia in patients with idiopathic pulmonary fibrosis (IPF) has been less emphasized. The aim of the study is to determine the prevalence of sarcopenia in patients with IPF and to evaluate the impact of sarcopenia on quality of life and disease progression.

This study was designed as a descriptive cross-sectional. The study included patients diagnosed with IPF. Hand dynamometry and bioelectrical impedance analysis (BIA) were used to for diagnose of sarcopenia. Pulmonary function tests, maximal inspiratory pressure (MIP), and maximal expiratory pressure (MEP) measurements were examined. The 6-minute walk distance (6MWD) and 4-meter walking speed were recorded. The St. George Respiratory Questionnaire (SGRQ) was used to assess quality of life. All patients were evaluated for progressive disease.

详细描述

The study was designed as a cross-sectional study.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being over 18 years of age
  • Signing the informed consent form
  • Having a diagnosis of IPF for at least one month

排除标准

  • Pregnancy
  • History of cancer within the last 5 years
  • History of lung surgery
  • History of neuromuscular disease
  • Active pulmonary tuberculosis
  • Active respiratory tract infection
  • Inability to perform pulmonary function tests
  • Presence of a pacemaker
  • History of systemic steroid use within the past 3 months
  • Inability to use a hand dynamometer

结局指标

主要结局

Hand Grip Strength

时间窗: through study completion, an average of 1 year

Hand Grip Strength (kg)- Grip strength measurement using a hand dynamometer

SMI (skeletal muscle mass index)

时间窗: through study completion, an average of 1 year

SMI (skeletal muscle mass index) (kg/m2) - SMI measurement using the Bioelectrical Impedance Analysis (BIA) device

Forced Expiratory Volume in 1 second (FEV1)

时间窗: through study completion, an average of 1 year

Measurement of FEV1 for the assessment of pulmonary function

Forced Vital Capacity (FVC)

时间窗: through study completion, an average of 1 year

Measurement of FVC for the assessment of pulmonary function

Diffusing Capacity of The Lungs for Carbon Monoxide (DLCO)

时间窗: through study completion, an average of 1 year

Measurement of DLCO for the assessment of pulmonary function.

Total Lung Capacity (TLC)

时间窗: through study completion, an average of 1 year

Measurement of TLC for the assessment of pulmonary function.

Respiratory Muscle Strength

时间窗: through study completion, an average of 1 year

Measurement of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) for assessment of respiratory muscle strength

Six Minute Walk Test (6MWT)

时间窗: through study completion, an average of 1 year

Distance walked in six minutes (m)

Gait speed

时间窗: through study completion, an average of 1 year

4-meter walking speed (m/s)

St. George's Respiratory Questionnaire (SGRQ)

时间窗: through study completion, an average of 1 year

The questionnaire is designed to measure quality of life. It consists of symptom, activity, impact, and total scores. Each score ranges from 0 to 100. High scores indicate lower quality of life.

Progressive Disease

时间窗: through study completion, an average of 1 year

Examination of all participants from clinical, physiological, and radiological perspectives

次要结局

  • Body Mass Index ( BMI)(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sibel Naycı

Prof. Dr.

Mersin University

研究点 (1)

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