Comparison of Active Cycle of Breathing Technique and Pursed Lip Breathing With TheraPep

NCT ID: NCT05691387

Last Updated: 2023-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-30
• Study Completion Date: 2023-05-15

Brief Summary

The purpose of this study is to investigate the short-term effects of two different breathing techniques (the active cycle breathing technique (ACBT) and the pursed lip breathing technique (PLB)) with Thera PEP® on the clearance of secretions and the oxygen saturation of individuals who have recently experienced an acute exacerbation of chronic obstructive pulmonary disease (COPD) in individuals who have recently experienced an acute exacerbation of COPD (COPD). Thirty patients will each have an acute COPD exacerbation seen on them, and then they will be randomly allocated to one of two groups (1. ACBT and PLB; 2. Thera PEP). Participants in a study employing a design known as a within-subject randomized crossover will be given the instruction to carry out each procedure on consecutive days as part of the study. In this study, the dependent variables will include blood pressure, heart rate, oxygen saturation (SpO2), respiratory rate, peak expiratory flow rate (PEFR), visual analog scale (VAS), sputum volume, and the breathlessness, cough, and sputum scale. In addition, the independent variables will include sputum volume (BCSC). The patient's desired course of treatment will also be taken into account. These dependent variables will be examined at three distinct moments in time: at the beginning of the study (the baseline), immediately after treatment, and thirty minutes after treatment has been completed.

Detailed Description

Methods:

There will be a total of thirty COPD patients recruited. Because of the rapid progression of their chronic obstructive pulmonary disease, these patients are going to need to be hospitalized. An acute exacerbation of COPD is suspected when there is an upper respiratory tract infection, a high temperature for no apparent reason, an increase in wheezing and coughing, or a rise in respiratory rate or heart rate above baseline. All of these symptoms are considered to be indications of an acute exacerbation of COPD. Co-morbidities, including but not limited to angina, indication for ventillatory support, neurological deficits, severe hemodynamic instability (including but not limited to cor pulmonale, cardiac arrhythmias, pulmonary embolism, pneumothorax, congestive heart failure, and GOLD stage IV: very severe COPD), and indication for ventilatory support will be used as exclusion criteria.

Interventions:

Individuals who will satisfy the inclusion and exclusion criteria will be given information regarding the two treatments (ACBT+PLB and PEP therapy to be offered by Thera PEP), and then they will be randomly randomized to either group (A or B) (A or B). Group A patients will get ACBT+PLB on day one of treatment, followed by PEP therapy using Thera PEP on day two. Treatment for patients in Group B will begin with PEP on Day 1, followed by ACBT+PLB on Day 2.

Sitting comfortably, patients receiving Thera PEP will be told to place dental cotton swabs between their cheek and gum, and then under their tongue, to absorb saliva and prevent contamination of the collected sputum by the patient's own saliva. The diameter of the opening will be modified to achieve a ventilation rate of 1:4. The patient will be taught to take in a larger than normal breath but not fill the lungs to capacity in order to maintain a tight seal during exhalation. After completing 10 PEP breaths, the patient will have the mouthpiece removed and be instructed to produce 2-3 "huff" coughs. When secretions need to be brought up, a good cough will do the trick. The patient will be instructed to do three sets of ten breaths each during the length of the therapy, which will last roughly thirty minutes in total. On the day of the ACBT, the patient will be instructed to place dental cotton swabs between the cheek and gum, as well as beneath the tongue, in order to absorb saliva and avoid the collected sputum from being tainted by the patient's own saliva. We'll want the patient to settle in for the duration of the procedure. After that, the patient will be given instructions to perform PLB at a normal tidal volume (for about 6 breaths), followed by 3-4 deep inspirations with relaxed exhalation (thoracic expansion exercise), and finally, another period of breathing control, i.e., PLB, followed by FET, i.e., a deep breath in and to do huff cough, followed by a medium breath in and again a huff cough. About thirty minutes will be spent in this procedure.

Outcome:

On day 0 (when no intervention is given), day 1 (at bedtime), and day 2, patients will be asked to fill out the sputum breathlessness cough scale (one of the dependent variables) (at bedtime). Besides the basics like pulse, blood pressure, and respiration rate, we'll also have a look at things like arterial oxygen saturation (SpO2), peak expiratory flow rate (PEFR), visual analog scale (VAS), and sputum volume to get a full picture of the patient's health (SV). Patients in both groups will be polled on which therapy modality they like best on Day 3.

Statistical analyses:

Data will be analyzed using SPSS for Windows, version 26. Treatment effects on the dependent variables will be analyzed using repeated-measures analysis of variance (ANOVA), with time as the within-subject component and the three measurements (baseline, posttest, and 30 minutes posttest) as the independent variables. Repeated-measures analysis will be used to examine correlations between participants, and a crossover layout will be used for variables that show statistical significance. The statistical study of the interaction between the period effect, the treatment period effect, and the treatment effect will be conducted using the independent-sample T-test. For the purposes of this research, a p value of 0.05 will be considered significant.

Conditions

Chronic Obstructive Pulmonary Disease Exacerbation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Thera PEP

Sitting comfortably, patients receiving Thera PEP will be told to place dental cotton swabs between their cheek and gum, and then under their tongue, to absorb saliva and prevent contamination of the collected sputum by the patient's own saliva. The diameter of the opening will be modified to achieve a ventilation rate of 1:4. The patient will be taught to take in a larger than normal breath but not fill the lungs to capacity in order to maintain a tight seal during exhalation. After completing ten PEP breaths, the patient will have the mouthpiece removed and be instructed to do two or three "puff" coughs. When secretions need to be brought up, a good cough will do the trick. During the duration of the treatment, which will last around thirty minutes, the patient will be asked to complete three cycles of ten breaths each.

Group Type: EXPERIMENTAL

Thera PEP

Intervention Type: BEHAVIORAL

Sitting comfortably, patients receiving Thera PEP will be told to place dental cotton swabs between their cheek and gum, and then under their tongue, to absorb saliva and prevent contamination of the collected sputum by the patient's own saliva. The diameter of the opening will be modified to achieve a ventilation rate of 1:4. The patient will be taught to take in a larger than normal breath but not fill the lungs to capacity in order to maintain a tight seal during exhalation. After completing ten PEP breaths, the patient will have the mouthpiece removed and be instructed to do two or three "puff" coughs. When secretions need to be brought up, a good cough will do the trick. During the duration of the treatment, which will last around thirty minutes, the patient will be asked to complete three cycles of ten breaths each.

ACBT and PLB

On the day of the ACBT, the patient will be taught to place dental cotton swabs between the cheek and gum, as well as beneath the tongue, to absorb saliva and prevent contamination of the collected sputum by saliva. Throughout the treatment, the patient will be urged to maintain a comfortable sitting position. The patient will then be instructed to perform PLB at a normal tidal volume (for approximately 6 breaths), followed by 3-4 deep inspirations with relaxed exhalation (thoracic expansion exercise), and finally, another period of breathing control, i.e. PLB, followed by FET, i.e. a deep breath in and a huff cough, followed by a medium breath in and a huff cough again. Approximately thirty minutes will pass over the course of this session.

Group Type: ACTIVE_COMPARATOR

ACBT and PLB

Intervention Type: BEHAVIORAL

On the day of the ACBT, the patient will be taught to place dental cotton swabs between the cheek and gum, as well as beneath the tongue, to absorb saliva and prevent contamination of the collected sputum by saliva. Throughout the treatment, the patient will be urged to maintain a comfortable sitting position. The patient will then be instructed to perform PLB at a normal tidal volume (for approximately 6 breaths), followed by 3-4 deep inspirations with relaxed exhalation (thoracic expansion exercise), and finally, another period of breathing control, i.e. PLB, followed by FET, i.e. a deep breath in and a huff cough, followed by a medium breath in and a huff cough again. Approximately thirty minutes will pass over the course of this session.

Interventions

Thera PEP

Sitting comfortably, patients receiving Thera PEP will be told to place dental cotton swabs between their cheek and gum, and then under their tongue, to absorb saliva and prevent contamination of the collected sputum by the patient's own saliva. The diameter of the opening will be modified to achieve a ventilation rate of 1:4. The patient will be taught to take in a larger than normal breath but not fill the lungs to capacity in order to maintain a tight seal during exhalation. After completing ten PEP breaths, the patient will have the mouthpiece removed and be instructed to do two or three "puff" coughs. When secretions need to be brought up, a good cough will do the trick. During the duration of the treatment, which will last around thirty minutes, the patient will be asked to complete three cycles of ten breaths each.

Intervention Type: BEHAVIORAL

ACBT and PLB

On the day of the ACBT, the patient will be taught to place dental cotton swabs between the cheek and gum, as well as beneath the tongue, to absorb saliva and prevent contamination of the collected sputum by saliva. Throughout the treatment, the patient will be urged to maintain a comfortable sitting position. The patient will then be instructed to perform PLB at a normal tidal volume (for approximately 6 breaths), followed by 3-4 deep inspirations with relaxed exhalation (thoracic expansion exercise), and finally, another period of breathing control, i.e. PLB, followed by FET, i.e. a deep breath in and a huff cough, followed by a medium breath in and a huff cough again. Approximately thirty minutes will pass over the course of this session.

Intervention Type: BEHAVIORAL

Other Intervention Names

ACBT and PLB

Eligibility Criteria

Inclusion Criteria

• Hospitalized patients because of a rapid worsening of chronic obstructive pulmonary disease
• An upper respiratory tract infection
• a high temperature for no apparent reason
• an increase in wheezing and coughing, or
• a rise in respiratory rate or heart rate above baseline

Exclusion Criteria

• Co-morbidities including but not limited to angina, indication for ventillatory support,
• neurological deficits,
• severe hemodynamic instability including but not limited to cor pulmonale, cardiac arrhythmias, pulmonary embolism, pneumothorax, congestive heart failure, and GOLD stage IV: very severe COPD; and
• indication for ventillatory support

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jazan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Mohammad Abu Shaphe

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abu Shaphe

Role: PRINCIPAL_INVESTIGATOR

University of Jazan

Locations

Jazan University

Jizan, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

REC-44/06/445

Identifier Type: -

Identifier Source: org_study_id