Effects of Active Cycle of Breathing Technique With and Without Acapella on Airway Clearance

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Effects of Active Cycle of Breathing Technique With and Without Acapella on Airway Clearance, Dyspnea and Pulmonary Function Test in Chronic Obstructive Pulmonary Disease Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05618847
• Other study ID #: REC&Mishal Sabir
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: February 2023

Study information

• Verified date: November 2022
• Source: Riphah International University
• Contact: Imran amjad, PHD
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We are conducting this study to check the effects of active cycle of breathing technique with or without acapella on airway clearance, dyspnea and pulmonary function test in COPD patients.

Study design will be randomized controlled trial. Research will be conducted at Aziz Bhatti Shaheed Teaching Hospital and National Hospital Gujrat. Written informed consent will be obtained. Patients will be allocated randomly in two groups. Subjects will meet the predetermined inclusion and exclusion criteria. Questionnaire used as subjective measurements of dyspnea and sputum will be given and pulmonary function test values will be obtained prior to any intervention. One group will receive active cycle of breathing technique and the other group will receive active cycle of breathing technique with acapella device. Every subject will perform supervised ACBTs with and without acapella for four weeks. Three sessions per week will be given with 20 repetitions in two sets. At the end of 4 weeks treatment session, pulmonary function test values will be monitored and questionnaire will be obtained for dyspnea and sputum. Data will be analyzed on SPSS 25

Description:

Chronic Obstructive Pulmonary Disease (COPD) is a non-communicable progressive and non-curable disease, characterized by persistent respiratory symptoms and airflow limitation. It is potentially fatal and it is the fourth cause of death in the world. Active Cycle of Breathing Techniques can be used to mobilize and clear excess pulmonary secretions and to generally improve lung function Loosen and clear secretions from the lungs. Three main phases of Active Cycle of Breathing Techniques are Breathing Control, Deep Breathing Exercises or Thoracic Expansion Exercises and Huffing or Forced Expiratory Technique. Acapella is a small hand held device for airway clearance. It has both resistive and vibratory features, which help to loosen and clear secretions from chest. This causes the vibration and resistance to the airflow which is then transmitted to the lungs. The resistance to the airflow will help to keep the airways open to get air behind the sputum and help it move upwards. The vibrations will help to loosen secretions from airways and move them up more easily for effective chest clearance. We are conducting this study to check the effects of active cycle of breathing technique with or without acapella on airway clearance, dyspnea and pulmonary function test in COPD patients.

Study design will be randomized controlled trial. Research will be conducted at Aziz Bhatti Shaheed Teaching Hospital and National Hospital Gujrat. Written informed consent will be obtained. Patients will be allocated randomly in two groups. Subjects will meet the predetermined inclusion and exclusion criteria. Questionnaire used as subjective measurements of dyspnea and sputum will be given and pulmonary function test values will be obtained prior to any intervention. One group will receive active cycle of breathing technique and the other group will receive active cycle of breathing technique with acapella device. Every subject will perform supervised ACBTs with and without acapella for four weeks. Three sessions per week will be given with 20 repetitions in two sets. At the end of 4 weeks treatment session, pulmonary function test values will be monitored and questionnaire will be obtained for dyspnea and sputum. Data will be analyzed on SPSS 25

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: February 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• • Age:45-75

• Both genders

• Mentally stable

• Diagnosed patients of COPD

Exclusion Criteria:

• • Any neurological condition

• Arrythmias

• Heart failure

• Previous heart or lung surgery

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Acapella,ACBTS
Every subject will perform supervised ACBTs with and without acapella for four weeks. Three sessions per week will be given with 20 repetitions in two sets

Other:
• ACBTs
Every subject will perform supervised ACBTs with and without acapella for four weeks. Three sessions per week will be given with 20 repetitions in two sets

Locations

Country	Name	City	State
Pakistan	Aziz bhatti shaheed teaching hospital	Gujrat	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sputum diary	The diary card has a graded symptom score for dyspnea, sputum volume and sputum color. In addition, the card includes a score for patient well-being and documented all minor symptoms (cough, chest pain, cold, or flu-like symptoms)	4 weeks
Primary	Dyspnea-MDP scale	The Multidimensional Dyspnea Profile (MDP) assesses overall breathing discomfort, sensory qualities, and emotional responses	4 weeks
Primary	Pulmonary function test	Pulmonary function tests (PFTS) are an important tool in the investigation and monitoring of patients with respiratory pathology. They provide important information relating to the large and small airways, the pulmonary parenchyma and the size and integrity of the pulmonary capillary bed	4 weeks