Clinical trial NCT05993520: Effects of Respiratory Muscle Functions on Interstitial Lung Disease: Sleep Quality, Dyspnea, and Fatigue
Official title: Effects of Respiratory Muscle Functions on Interstitial Lung Disease: Sleep Quality, Dyspnea, and Fatigue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Lung Disease
Keywords: Interstitial Lung Disease
Respiratory Muscles
Sleep
Quality of Life
Fatigue
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: TURK TORAKS DERNEGI
First posted: 2023-08-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: sleep quality-1
timeFrame: 5 minutes
measure: Sleep Apnea
timeFrame: 5 minutes
measure: Modified Medical Research Council Questionnaire
timeFrame: 5 minutes
measure: Dyspnea-12 Scale
timeFrame: 5 minutes
measure: fatigue
timeFrame: 5 minutes
measure: Respiratory Function Test
timeFrame: 5 minutes
measure: Respiratory Muscle Strength
timeFrame: 5 minutes
measure: Comorbidity
timeFrame: 3 minutes
measure: Respiratory Muscle Endurance:
timeFrame: 8 minutes
Secondary outcomes:
measure: Cough
timeFrame: 5 minutes
measure: Symptoms Seveerity
timeFrame: 1 minutes
measure: exercise capacity
timeFrame: 8 minutes
measure: peripheral muscle strength
timeFrame: 5 minutes
measure: anxiety&depression
timeFrame: 5 minutes
measure: health problems
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Üniversitesi-Cerrahpaşa
state: Buyucekmece
Study officials:
References:
citation: 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.