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

NCT05993520 | Completed

• 1 other identifier: GAslan-2023
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Interstitial Lung Disease

Keywords

Interstitial Lung Disease; Respiratory Muscles; Sleep; Quality of Life; Fatigue

Outcome Measures

Primary Outcomes (9)

• sleep quality-1

  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.

  5 minutes

• Sleep Apnea

  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.

  5 minutes

• Modified Medical Research Council Questionnaire

  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.

  5 minutes

• Dyspnea-12 Scale

  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.

  5 minutes

• fatigue

  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.

  5 minutes

• Respiratory Function Test

  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.

  5 minutes

• Respiratory Muscle Strength

  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.

  5 minutes

• Comorbidity

  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.

  3 minutes

• Respiratory Muscle Endurance:

  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.

  8 minutes

Secondary Outcomes (6)

• Cough

  5 minutes

• Symptoms Seveerity

  1 minutes

• exercise capacity

  8 minutes

• peripheral muscle strength

  5 minutes

• anxiety&depression

  5 minutes

Study Arms (1)

Interstitial Lung Disease

Between June 2020 and June 2023, a total of 36 voluntary participants, aged 18 and above, who were receiving treatment at the Department of Chest Diseases, Istanbul Faculty of Medicine, Istanbul University, and met the inclusion criteria, were included in the study.

Other: Assessment

Interventions

Assessment OTHER

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.

Interstitial Lung Disease

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Between June 2020 and June 2023, a total of 36 voluntary participants, aged 18 and above, who were receiving treatment at the Department of Chest Diseases, Istanbul Faculty of Medicine, Istanbul University, and met the inclusion criteria were included in the study.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead
• TURK TORAKS DERNEGI: collaborator

Study Sites (1)

İstanbul Üniversitesi-Cerrahpaşa

Istanbul, Buyucekmece, Turkey (Türkiye)

Location

Related Publications (1)

• Bloem AEM, Houben-Wilke S, Mostard RLM, Stoot N, Janssen DJA, Franssen FME, Custers JWH, Spruit MA. Respiratory and non-respiratory symptoms in patients with IPF or sarcoidosis and controls. Heart Lung. 2023 Sep-Oct;61:136-146. doi: 10.1016/j.hrtlng.2023.05.013. Epub 2023 Jun 2.

  PMID: 37269615 RESULT

MeSH Terms

Conditions

Lung Diseases, Interstitial; Fatigue

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 15, 2023
• Study Start: June 1, 2020
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)