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

NCT05691387 | Completed DMC

• 1 other identifier: REC-44/06/445
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease Exacerbation

Keywords

chronic obstructive pulmonary disease; pursed lip breathing; active cycle breathing technique; airway clearance technique

Outcome Measures

Primary Outcomes (8)

• blood pressure

  A digital blood pressure monitor will be used. A tight-fitting arm cuff will be wrapped around the participant's upper arm before being inflated with air. Blood pressure that falls within the range of 90/60 mm Hg to 120/80 mm Hg is considered normal. Measurements of blood pressure will be taken before and after the intervention.

  Day 3

• heart rate

  Heart rate will be measured with a digital monitor while the person is supine at the beginning of the study and at the end of the intervention.

  Day 3

• oxygen saturation (SpO2)

  The oxygen saturation (SpO2) of the blood is a ratio of the amount of oxygen-carrying hemoglobin to the amount of total hemoglobin. Blood saturation levels of oxygen (SpO2) will be determined with the help of a pulse oximeter. The participant's finger will be positioned to receive the pulse oximeter. On the screen, you'll see a %. The usual range for this percentage, which measures how much oxygen hemoglobin can transport, is between 94% and 100%. This will be taken at baseline and end of intervention.

  Day 3

• respiratory rate

  The number of times in a minute that a person breathes is called their respiratory rate. An adult taking it easy should be breathing at a pace of 12-20 breaths per minute. It's abnormal to have a resting respiratory rate of less than 12 or more than 25 breaths per minute. This will be taken at baseline and end of intervention.

  Day 3

• peak expiratory flow rate (PEFR)

  A peak flow meter is a portable, hand-held instrument used to measure a person's maximal rate of exhalation (also known as peak expiratory flow or PEF). The test determines how much of an obstruction there is in the airways by measuring the airflow through the bronchi. Most of the time, people will use liters per minute (L/min) to describe their peak expiratory flow. When recording a patient's Peak Expiratory Flow Rate, the highest value from a set of three measurements will be used. This will be taken at baseline and end of intervention.

  Day 3

• visual analog scale (VAS)

  A visual analogue scale (VAS) is a line, typically 10 cm long, with word anchors at either end (such as "no pain" on the far left and "the most extreme pain imaginable" on the far right) to indicate a range of perceived discomfort. In order to indicate the level of pain experienced, the patient makes a mark on the line at the location that best represents their perception of that level of discomfort. A higher score indicate worst intensity of pain. This will be taken at baseline and end of intervention.

  Day 3

• sputum volume

  When the muco-ciliary escalator is working properly, the normal lung produces about 20 to 30 milliliters of mucus daily. When an excessive amount of mucus is formed in the airways and must be expectorated, this excess mucus is referred to as sputum. This will be taken at baseline and end of intervention.

  Day 3

• the breathlessness, cough, and sputum scale (BCSC)

  Patients will be requested to complete the sputum breathlessness cough scale (one of the dependent variables) on day 0 (when no intervention was given), at the end of day 1 (at bedtime), and at the end of day 2 (at bedtime).

  Day 3

Study Arms (2)

Thera PEP

EXPERIMENTAL

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.

Behavioral: Thera PEP

ACBT and PLB

ACTIVE COMPARATOR

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.

Behavioral: ACBT and PLB

Interventions

Thera PEP 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.

Also known as: ACBT and PLB

Thera PEP

ACBT and PLB 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.

ACBT and PLB

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jazan: lead

Study Sites (1)

Jazan University

Jizan, Saudi Arabia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

phospholamban

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Abu Shaphe

  University of Jazan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 20, 2023
• Study Start: December 30, 2022
• Primary Completion: April 10, 2023
• Study Completion: May 15, 2023
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)