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

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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: Acapella,ACBTS; Other: ACBTs

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Gujrāt, Punjab, Pakistan, 053
      • Recruiting
      • Aziz Bhatti Shaheed Teaching Hospital
      • Contact: madiha younas, MS; Phone Number: 0333-8148025; Email: madiha.younas@riphah.edu.pk
      • Sub-Investigator: Mishal Sabir, MSCPPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active cycle of breathing technique with acapella; Sit up with good posture to use the Acapella. Take in a fairly deep breath and hold it for about 3 seconds. Place the Acapella mouthpiece in your mouth. Seal your lips tightly around the mouthpiece. Exhale as much as possible (but not to forcefully) through the mouthpiece. Keep your cheeks as firm as possible when you exhale. Try not to inhale through the device. Repeat this maneuver for 10 breaths. Try to resist coughing during this phase. After these 10 blows, perform 3 huffs, then a big cough to bring the sputum up and out. Try not to swallow the mucus	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
Active Comparator: active cycle of breathing technique; Ask patient to breathe in and out gently through nose if he/she can. If patient breathe out through their mouth. Ask patient to let go of any tension in body with each breath out. Gradually try to make the breaths slower. Ask patient to take a long, slow, deep breath in, through nose. Try to keep chest and shoulders relaxed. Repeat 3-5 times. Huff is exhaling through an open mouth and throat instead of coughing. It helps move sputum up in airways so that patient can clear it in a controlled way. To 'huff' ask patient to squeeze air quickly from lungs, out through open mouth and throat, as if trying to mist up a mirror or glasses. Ask to use abdominal muscles to help squeeze the air out, but do not force it so much that cause wheezing or tightness in chest. Huffing should always be followed by breathing control.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Dyspnea-MDP scale	The Multidimensional Dyspnea Profile (MDP) assesses overall breathing discomfort, sensory qualities, and emotional responses	4 weeks
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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: madiha younas, MS, Riphah Internationl University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 16, 2022

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: ACBT, Acapella, COPD, PEP
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: REC&Mishal Sabir

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No