The Effect of Airway and Chest Wall Oscillation on Respiratory Functions in COPD Patients in Acute Exacerbation

NCT ID: NCT06274957

Last Updated: 2024-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2024-06-17

Brief Summary

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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

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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.

Conditions

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COPD Exacerbation Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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control

Conventional training was applied to the patients

Group Type EXPERIMENTAL

CONTROL

Intervention Type OTHER

Pursed Lips breathing exercise, Active Respiratory Techniques Cycle, Postural Drainage, Mobilization, Calisthenic Exercises, and Patient Education. Relaxation positions and energy conservation techniques were taught in Patient Education

Positive Expiratory Pressure

We applied PEP (positive expiratory pressure) therapy in adddition to the conventional exercises

Group Type EXPERIMENTAL

PEP DEVICE

Intervention Type DEVICE

Pursed Lips breathing exercise, Active Respiratory Techniques Cycle, Postural Drainage, Mobilization, Calisthenic Exercises, and Patient Education. Relaxation positions and energy conservation techniques were taught in Patient Education

PEP training was applied using the Acapella device.

In addition, participants were subjected to two sessions of 10 minutes each with the Acapella device. In the study, the Acapella device, capable of sustaining expiratory flow of at least 15 L/min for 3 seconds, was activated by taking a deep breath, holding the breath for 2-3 seconds, and then exhaling into the device.

High Frequency Chest Wall Oscillation

We applied HFCWO (High Frequency Chest Wall Oscillation) in addition to the conventional exercises

Group Type EXPERIMENTAL

HFCWO DEVICE

Intervention Type DEVICE

Patients were provided with conventional exercises including Pursed Lips breathing exercise, Active Respiratory Techniques Cycle, Postural Drainage, Mobilization, Calisthenic Exercises, and Patient Education. Relaxation positions and energy conservation techniques were taught in Patient Education

In addition, participants will receive High-Frequency Chest Wall Oscillation (HFCWO) therapy twice a day for 10 minutes each.

HFCWO training was applıed using the WEST device

Interventions

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CONTROL

Pursed Lips breathing exercise, Active Respiratory Techniques Cycle, Postural Drainage, Mobilization, Calisthenic Exercises, and Patient Education. Relaxation positions and energy conservation techniques were taught in Patient Education

Intervention Type OTHER

PEP DEVICE

Pursed Lips breathing exercise, Active Respiratory Techniques Cycle, Postural Drainage, Mobilization, Calisthenic Exercises, and Patient Education. Relaxation positions and energy conservation techniques were taught in Patient Education

PEP training was applied using the Acapella device.

In addition, participants were subjected to two sessions of 10 minutes each with the Acapella device. In the study, the Acapella device, capable of sustaining expiratory flow of at least 15 L/min for 3 seconds, was activated by taking a deep breath, holding the breath for 2-3 seconds, and then exhaling into the device.

Intervention Type DEVICE

HFCWO DEVICE

Patients were provided with conventional exercises including Pursed Lips breathing exercise, Active Respiratory Techniques Cycle, Postural Drainage, Mobilization, Calisthenic Exercises, and Patient Education. Relaxation positions and energy conservation techniques were taught in Patient Education

In addition, participants will receive High-Frequency Chest Wall Oscillation (HFCWO) therapy twice a day for 10 minutes each.

HFCWO training was applıed using the WEST device

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gulhane Training and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Gamze Altınkaynak

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ZUHAL KUNDURACILAR, PROF. DR.

Role: STUDY_DIRECTOR

SAGLIK BILIMLERI UNI

GAMZE KOYUTURK, PT, PHD (C)

Role: PRINCIPAL_INVESTIGATOR

SAGLIK BILIMLERI UNI

AYSUNA DINCER, DOCTOR

Role: STUDY_CHAIR

SAGLIK BILIMLERI UNI

MEHMET YUKSEKKAYA, ASIST PROF

Role: STUDY_CHAIR

ANKARA UNI

Locations

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University of Health Sciences

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Zuhal KUNDURACILAR, PROF. DR.

Role: CONTACT

+905302195286

GAMZE KOYUTÜRK PT, PhD(c)

Role: CONTACT

Facility Contacts

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ZUHAL KUNDURACILAR PROF DR

Role: primary

+90 530 219 5286

GAMZE KOYUTÜRK PT, PhD(c)

Role: backup

+90 5065798671

Other Identifiers

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SaglikBilimleriUN

Identifier Type: -

Identifier Source: org_study_id

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