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临床试验/NCT05993520
NCT05993520已完成不适用

Effects of Respiratory Muscle Functions on Interstitial Lung Disease: Sleep Quality, Dyspnea, and Fatigue

Istanbul University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Respiratory Muscle Strength

研究概览

简要总结

Although there are numerous data demonstrating the impact of Interstitial Lung Disease (ILD) on respiratory functions, there is a lack of studies investigating the effects of respiratory functions on parameters such as sleep quality, dyspnea, and fatigue. The primary objective of the study is to examine the influence of changes in respiratory muscle functions in ILD on sleep quality, dyspnea, and fatigue parameters. The secondary objective is to investigate the effects of respiratory muscle functions in ILD on parameters such as cough, pain, exercise capacity, peripheral muscle strength, anxiety, depression, and quality of life.

详细描述

Introduction

Despite having numerous data demonstrating the impact of Interstitial Airway Disease (IAD) on respiratory functions, there is a lack of studies investigating the effects of respiratory functions on parameters such as sleep quality, dyspnea, and fatigue. The primary objective of the study is to examine the effects of changes in respiratory muscle functions in IAD on sleep quality, dyspnea, and fatigue parameters. The secondary objective is to investigate the effects of respiratory muscle functions in IAD on parameters such as cough, pain, exercise capacity, peripheral muscle strength, anxiety, depression, and quality of life.

Methods: Between June 2020 and June 2023, 36 volunteer participants aged 18 and above, who were receiving treatment in the Department of Chest Diseases at Istanbul University, Istanbul Faculty of Medicine, and met the inclusion criteria, were included in the project. Participants' respiratory function tests, respiratory muscle functions, dyspnea levels, cough, sleep quality, peripheral muscle strength, quality of life, exercise capacity, and fatigue levels were evaluated. Pearson Correlation Test was applied to determine the relationship between variables. Multiple linear regression analysis was used to examine factors that could affect respiratory muscle strength and endurance values.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being 18 years of age or older.
  • Having a diagnosis of Interstitial Lung Disease (ILD) by a chest diseases specialist.

排除标准

  • Systemic involvement of ILD
  • Cooperation problem
  • Presence of orthopedic/neurological issues hindering walking and exercise.
  • Uncontrolled cardiovascular disease.
  • Presence of acute upper and lower respiratory tract infections.

结局指标

主要结局

Respiratory Muscle Strength

时间窗: 5 minutes

Respiratory Muscle Strength: The easiest and most common method is measuring mouth pressure during voluntary contraction against a closed airway to open the airway. In the study, respiratory muscle strength will be evaluated using the "Vyaire Medical MicroRPM" device. Maximum Inspiratory Pressure (MIP): At least three measurements are taken, and the highest value is recorded. Maximum Expiratory Pressure (MEP): The best of at least three measurements is recorded.

sleep quality-1

时间窗: 5 minutes

Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality. PSQI is a scale consisting of 24 questions that evaluate sleep quality and disturbances in the past month. Each item is scored between 0 and 3, and a total score higher than 5 indicates insufficient sleep quality in the individual.

Sleep Apnea

时间窗: 5 minutes

Obstructive Sleep Apnea Syndrome Risk: The STOP-BANG questionnaire will be used to assess the risk of Obstructive Sleep Apnea Syndrome (OSAS). The questionnaire consists of a total of eight questions that are answered with "yes" or "no." In the STOP section of the questionnaire, if at least two out of the four questions are answered "yes," it is considered a high risk for OSAS.

Dyspnea-12 Scale

时间窗: 5 minutes

To assess dyspnea, the Dyspnea-12 Scale will be used. The Dyspnea-12 Scale is a 12-item questionnaire that measures the intensity of dyspnea. It consists of a four-point Likert-type scale (0=none, 1=mild, 2=moderate, 3=severe) as response options.The minimum score is 0, and the maximum score is 36. An increase in the score indicates an increase in the severity of dyspnea experienced by the patient.

Respiratory Muscle Endurance:

时间窗: 8 minutes

Respiratory Muscle Endurance: In respiratory muscle endurance measurement, an incremental threshold load test will be applied using the "Threshold IMT" device. According to the incremental threshold load protocol, after determining the MIP value, the threshold pressure is set at approximately 20-40% of MIP. The threshold pressure is increased every two minutes. The highest pressure that the patient can sustain for at least one minute is recorded as the patient's respiratory muscle endurance value.

Modified Medical Research Council Questionnaire

时间窗: 5 minutes

To assess dyspnea, the Modified Medical Research Council (mMRC) Questionnaire will be used. The mMRC is a scale used to assess the level of dyspnea during daily life activities. It involves a five-point category scale (0 to 4) in which patients choose the expression that best describes their level of dyspnea. As the score increases, the severity of dyspnea also increases.

fatigue

时间窗: 5 minutes

For the assessment of fatigue, the Fatigue Assessment Scale (FAS) will be used. The FAS is a subjective fatigue questionnaire consisting of 10 items. It utilizes a five-point Likert scale (1=Always-5=Never) as response options. The total scores that can be obtained from the FAS range from 10 to 50. Higher scores indicate a higher level of fatigue experienced by the individual.

Respiratory Function Test

时间窗: 5 minutes

Respiratory Function Test: The respiratory function status of patients will be assessed using spirometric testing.Spirometry is a medical test used to assess the functioning of the lungs. It measures the amount of air a person can inhale and exhale, as well as the speed and volume of airflow. This test is essential for diagnosing and monitoring lung conditions such as interstitial lung disease, chronic obstructive pulmonary disease (COPD), and other respiratory disorders.The spirometry results are compared to predicted values based on factors such as age, height, sex, and ethnicity. This comparison helps healthcare professionals identify any deviations from normal lung function.

Comorbidity

时间窗: 3 minutes

Charlson Comorbidity Index: It is a widely used index in clinical practice that queries chronic systemic diseases, assesses their frequency and relationships. It consists of nineteen different items. The scores obtained from the patient's comorbid conditions are added together to obtain a score, and a score is also added based on the patient's age. This age score is 1 for ages 50-59, 2 for ages 60-69, 3 for ages 70-79, 4 for ages 80-89, and 5 for ages 90-99.

次要结局

  • Cough(5 minutes)
  • health problems(5 minutes)
  • anxiety&depression(5 minutes)
  • Symptoms Seveerity(1 minutes)
  • peripheral muscle strength(5 minutes)
  • exercise capacity(8 minutes)

研究者

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

Goksen Kuran Aslan

Associate professor

Istanbul University - Cerrahpasa (IUC)

研究点 (1)

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