Clinical trial NCT06274957: The Effect of Airway and Chest Wall Oscillation on Respiratory Functions in COPD Patients in Acute Exacerbation
Official title: The Effect of Airway Oscillation and Chest Wall Oscillation on Respiratory Functions and Sleep Quality in COPD Patients in Acute Exacerbation Period and Technical Inspection of Devices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD Exacerbation Acute
Keywords: copd
pep
hfcwo
airway clearance techniques
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
Collaborators: name: Gulhane Training and Research Hospital
First posted: 2024-02-23
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic obstructive pulmonary disease (COPD); It is a common, treatable and preventable disease characterized by progressive and irreversible airflow limitation and has systemic effects with respiratory system involvement. Increased respiratory workload, decreased work .

Detailed description: Chronic obstructive pulmonary disease (COPD); It is a common, treatable and preventable disease characterized by progressive and irreversible airflow limitation and has systemic effects with respiratory system involvement. Increased respiratory workload, decreased work of breathing in patients are important factors that cause respiratory and peripheral muscle strength and functional capacity exercise intolerance. It is defined as an exacerbation if there is an increase in shortness of breath, cough, sputum amount and purulence, which necessitates a change in treatment in the COPD patients. In the guides; Individualized exercise training for disease management is an essential component of these programs. In the literature; Although there are many studies showing the beneficial effects of traditional exercise training programs in patients with COPD, physiotherapy applications used in the exacerbation period are recommended, but there are not many studies examining the device technologies used in this area. In this period, devices that provide chest wall oscillation and airway oscillation can be preferred for the symptomatic treatment of increasing cough and sputum complaints. There is no study comparing these two methods that we know of. Our study will be carried out on 33 patients hospitalized in the Pulmonology Service of the Health Sciences University Gülhane Training and Research Hospital, followed up with the diagnosis of COPD exacerbation, who met the inclusion criteria and accepted to participate in the study on a voluntary basis. Patients will be randomized into 3 groups as 2 experiments and 1 control. Measurements of patients admitted to the ward will be made at the beginning and end of the study. Socio-demographic data of the patient, chest circumference measurement, COPD assessment test, mMRC dyspnea scale, BODE index, pulmonary function test, arterial blood gas, chest X-ray, 30-second sit and stand test, Richard-Campbell Sleep Scale, Clinical COPD Questionnaire, Charlson comorbidity index will be applied. Pursed-lip breathing, active breathing techniques cycle, bronchial hygiene techniques, mobilization, calisthenic exercises and patient education (teaching relaxation positions and energy conservation techniques) will be applied to the patients in the study and control groups during their hospitalization. Chest wall oscillation will be practiced together with chest physiotherapy in the 1st experimental group, and airway oscillation will be practiced in the 2nd experimental group with the same physiotherapy program. In the study, the clinical use and technical features of the devices will be examined.

Eligibility criteria: Inclusion Criteria:

* Being classified as GOLD stage 3 or 4 based on spirometric evaluation in the medical history.
* Having a hospital admission within the specified time frame, evaluated by a pulmonary specialist, and admitted to the pulmonary diseases service with a diagnosis of COPD exacerbation.
* Being 40 years of age or older.
* Voluntarily agreeing to participate in the study.

Exclusion Criteria:

* Having a hospital admission with a diagnosis of asthma attack in the last 5 years.
* Monitoring suspicious focal points for pneumonia on lung radiology.
* Hospitalization due to reasons other than exacerbation despite having a diagnosis of COPD.
* Presence of pulmonary fibrosis or suspicious findings of fibrosis on radiology.
* Systemic fungal infections.
* Having cognitive impairment affecting the decision to participate in the study, such as confusion, orientation disorder, or dementia.
* Patients with lung cancer or metastasis in the lungs.
* Diagnosis of conditions provoking shortness of breath other than COPD exacerbation, such as pneumonia, pneumothorax, heart failure, and pulmonary embolism.
* Presence of a new-onset rhythm disorder or ischemic changes requiring intervention on the EKG, excluding sinus tachycardia and multifocal atrial tachycardia.
* Chronic kidney failure requiring hemodialysis.
* Patients with conditions causing weakness in the lower extremities, such as arthritis, neurological disease, deep vein thrombosis, peripheral artery disease, muscle weakness, fractures, osteoarthritis, etc.
* Having ankylosing spondylitis with a Cobb angle of 10 degrees or more in the radiographic evaluation of the vertebral column.
* Having undergone surgery on the upper extremities, lower extremities, neck, and back.

Primary outcomes:
measure: COPD assessment test
timeFrame: The first and last day of the training will be measured an avarage 7 days
measure: Clinical COPD Questionnaire
timeFrame: The first and last day of the training will be measured an avarage 7 days
measure: mMRC dyspnea scale
timeFrame: The first and last day of the training will be measured an avarage 7 days
measure: Richard-Campbell Sleep Questionnaire
timeFrame: The first and last day of the training will be measured an avarage 7 days
measure: 30 second sit and stand
timeFrame: The first and last day of the training will be measured an avarage 7 days
measure: BODE index
timeFrame: The first and last day of the training will be measured an avarage 7 days
measure: chest circumference measurements
timeFrame: The first and last day of the training will be measured an avarage 7 days
measure: Modified Borg Scale
timeFrame: The first and last day of the training will be measured an avarage 7 days
measure: muscle strenght test
timeFrame: The first and last day of the training will be measured an avarage 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences
Study officials:
affiliation: SAGLIK BILIMLERI UNI
name: ZUHAL KUNDURACILAR, PROF. DR.
role: STUDY_DIRECTOR
affiliation: SAGLIK BILIMLERI UNI
name: GAMZE KOYUTURK, PT, PHD (C)
role: PRINCIPAL_INVESTIGATOR
affiliation: SAGLIK BILIMLERI UNI
name: AYSUNA DINCER, DOCTOR
role: STUDY_CHAIR
affiliation: ANKARA UNI
name: MEHMET YUKSEKKAYA, ASIST PROF
role: STUDY_CHAIR
References: