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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Acapella,ACBTS
ACBTs
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring ACBT, Acapella, COPD, PEP

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aziz bhatti shaheed teaching hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

active cycle of breathing technique with acapella

active cycle of breathing technique

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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)
Dyspnea-MDP scale
The Multidimensional Dyspnea Profile (MDP) assesses overall breathing discomfort, sensory qualities, and emotional responses
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

Secondary Outcome Measures

Full Information

First Posted
November 8, 2022
Last Updated
November 8, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05618847
Brief Title
Effects of Active Cycle of Breathing Technique With and Without Acapella on Airway Clearance
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
ACBT, Acapella, COPD, PEP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active cycle of breathing technique with acapella
Arm Type
Experimental
Arm Description
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
Arm Title
active cycle of breathing technique
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Acapella,ACBTS
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
ACBTs
Intervention Description
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
Primary Outcome Measure Information:
Title
Sputum diary
Description
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)
Time Frame
4 weeks
Title
Dyspnea-MDP scale
Description
The Multidimensional Dyspnea Profile (MDP) assesses overall breathing discomfort, sensory qualities, and emotional responses
Time Frame
4 weeks
Title
Pulmonary function test
Description
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
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran amjad, PHD
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madiha younas, MS
Organizational Affiliation
riphah internationl university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aziz bhatti shaheed teaching hospital
City
Gujrāt
State/Province
Punjab
ZIP/Postal Code
053
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madiha younas, MS
Phone
0333-8148025
Email
madiha.younas@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Mishal Sabir, MSCPPT

12. IPD Sharing Statement

Plan to Share IPD
No

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

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