- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06242210
Effects of Pursed Lip Breathing Technique Versus Stacked Breathing Technique Among Chronic Bronchitis Patients
April 18, 2024 updated by: Riphah International University
Effects of Pursed Lip Breathing Technique Versus Stacked Breathing Technique on Dyspnea, Lung Volumes, Oxygenation, and Quality of Life Among Chronic Bronchitis Patients
Chronic bronchitis is a non-allergic, inflammatory disease that is developed because of inflamed bronchial walls, and, is characterized by persistent cough with sputum for 3 months for 2 consecutive years at least.
It affects males more than females at the age of 40 years, with increasing incidence as the age progresses.
Chronic bronchitis is associated with multiple health-related issues like; dyspnea, reduced lung volumes and capacities, poor quality of life, and physical inactivity.
Its clinical manifestations are coped with using the pharmaceutical approach, surgical maneuvers, and pulmonary rehabilitation.
In the context of pulmonary rehabilitation, pursed lip breathing and stacked breathing are evident to deal with symptoms of chronic bronchitis and make the individuals lead a physically active and healthy life.
In this research study, patients will be enrolled with strict adherence to eligibility criteria and then allocated into two groups by using the convenience sampling technique after having their written informed consent form.
The participants will either receive pursed lip breathing technique or a stacked breathing technique, which will be followed by baseline treatment at every session.
Both groups will be then subjected to receive intervention that will take a duration of 40 minutes every session, 30 minutes of baseline treatment, and 10 minutes of intervention, for the period of 2 weeks with the frequency of performing the intervention thrice per day.
The outcomes will be evaluated by using a modified Borg scale for dyspnea, a peak expiratory flow meter for lung volumes, a pulse oximeter for oxygenation, and EuroQol; 5D-5L for quality of life.
Data will be recorded at pre-treatment, on the 1st day, and post-treatment, on the 14th day.
The recorded data will be then entered and analyzed using SPSS (Statistical Package of Social Sciences) version 23.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan, 54000
- Sheikh Zayed Hospital,
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Both genders will be included.
- Patients lie in the age ranges from 40 to 60 years.
- Patients diagnosed with chronic bronchitis. for more than one year.
- Patients presents with reduction in movements of chest wall, which reduces the area of entrance for air.
- Patients who have no history of usage of corticosteroids and anabolic steroid from previous three months.
- Patients do not experience severe obstruction of airflow i.e.: value of FEV1 is at 50% of the predicted value.
- Patients have no history or persistence of COVID-19
Exclusion Criteria:
• Any recent thoracic surgeries and abdominal surgeries.
- Patients lie at the Grade IV of modified medical research council dyspnea scale.
- Patients who present with history of any respiratory disease from two preceding months.
- Patients receiving any maneuvers of pulmonary rehabilitation from previous two months.
- Patients who experience chronic respiratory failure demanding for supplemental oxygen.
- Patients have persisting cardiac and pulmonary hypertension that interferes with compliance of intervention.
- Patients who had other chronic respiratory diseases, new or current smoker, and had respiratory tract infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pursed Lip Breathing Technique
Patient will be asked to attain fowler's position by placing a pillow in front of his trunk to support a comfortable breathing pattern.
Then, patient will be instructed to inhale through nose deeply until no more air can be inhaled and which will be followed by a slow expiration through pursed or rounded lip, like at the time of whistling.Patient will also be demonstrated visually for the proper breathing pattern even for once to multiple times till complete understanding before performing itself.
The technique will be administered to the patient under supervision for 10 minutes, and the patient will be instructed to use this trained exercise in his daily routine as per needed.
|
pursed lip breathing technique for group A through videos on smart phones and a brochure given to patients.
Each session takes 15-20 minutes until researchers ensure that patients understand how to perform exercises and re-demonstrate them.
• Each group applied it twice per day for a period of 4 weeks.
Telephone follow-up was used for patients in both groups
|
|
Experimental: Stacked Breathing
Patient will be asked to attain recumbent position by lying supine at a reclining angle to support a comfortable breathing pattern.
Then, patient will be instructed to inhale slowly and deeply once through nose and hold it, then inhale again slowly and deeply through nose and trap the air in again over the first one, then inhale again until no more air can be inhaled and which will be held for a bit then followed by a slow and quiet expiration.
Patient will also be demonstrated visually for the proper breathing pattern even for once to multiple times till complete understanding before performing itself
|
The technique will be administered to the patient under supervision for 10 minutes, and the patient will be instructed to use this trained exercise in his daily routine as per needed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Borg Scale
Time Frame: baseline and fourth week
|
The Modified Borg Dyspnea Scale has demonstrated both validity and reliability in various populations, including both healthy individuals and clinical patients with a highly significant values of Pearson's correlation coefficient and Spearman's correlation coefficient that lies within the range of 0.5 to 0.99, which showsa p-value of less than 0.05.
Its ease of use has made it widely employed for monitoring exercise intensity in exercise prescription and rehabilitation settings
|
baseline and fourth week
|
|
Spirometer
Time Frame: baseline and fourth week
|
Spirometry is a maneuver that works on the principle of forced expiration, and is constituted of FEV1; that signifies the volume of air pushed out of lung forcefully within one second, FVC; which represents the forced vital capacity of lungs and ratio of FEV1 / FVC, to measure the limitation faced by patients of chronic bronchitis during airflow.
Spirometry is considered to be a gold standard instrument that has been employed to assess the forced expiratory flow parameters among patients of COPD, asthma, chronic bronchitis.
It been proven to be a highly reliable and valid tool on the basis of value of 95% confidence interval that was determined from 0.51 to 0.86, with the purpose to keep lung volumes under surveillance
|
baseline and fourth week
|
|
Pulse Oximeter
Time Frame: baseline and fourth week
|
Healthcare professionals worldwide use pulse oximeter on a daily basis to obtain a noninvasive measurement of SpO2, which reflects arterial oxygen saturation (SaO2).
This measurement aids in identifying and addressing hypoxemia (low oxygen levels) and hyperoxemia (high oxygen levels).
Pulse oximetry monitoring is commonly regarded as the fifth vital sign and is particularly recommended for patients in need of oxygen therapy
|
baseline and fourth week
|
|
European Quality of Life; 5 Dimensions, 5 Levels Questionnaire
Time Frame: baseline and fourth week
|
The EQ-5D-5L includes a descriptive system consisting of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with one item per dimension.
By assigning preference-based weights (usually specific to each country), the responses to these items can be converted into a single measure of health utility.
Furthermore, the instrument provides instructions for indicating overall health status of present day on a visual analog scale.EuroQol;5D-5L is a valid and reliable tools with inter-rater correlation coefficient value of 0.7, and a value of convergent validity of 0.756 under the domain of Spearman Rho Rank correlation coefficient
|
baseline and fourth week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Madiha Younis, MSPT (CP), Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Venkatesan P. GOLD COPD report: 2023 update. Lancet Respir Med. 2023 Jan;11(1):18. doi: 10.1016/S2213-2600(22)00494-5. Epub 2022 Nov 30. No abstract available.
- Mayr AK, Valipour A. Modern Bronchoscopic Treatment Options for Patients with Chronic Bronchitis. J Clin Med. 2023 Feb 26;12(5):1854. doi: 10.3390/jcm12051854.
- Satia I, Mayhew AJ, Sohel N, Kurmi O, Killian KJ, O'Connell ME, O'Byrne PM, Raina P. Language and geographical location influence the incidence of chronic cough in the Canadian Longitudinal Study on Aging. ERJ Open Res. 2022 Feb 21;8(1):00721-2021. doi: 10.1183/23120541.00721-2021. eCollection 2022 Jan.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2024
Primary Completion (Actual)
March 15, 2024
Study Completion (Actual)
April 15, 2024
Study Registration Dates
First Submitted
January 28, 2024
First Submitted That Met QC Criteria
January 28, 2024
First Posted (Actual)
February 5, 2024
Study Record Updates
Last Update Posted (Actual)
April 19, 2024
Last Update Submitted That Met QC Criteria
April 18, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Disease Attributes
- Bronchial Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Chronic Disease
- Respiratory Aspiration
- Acute Disease
- Bronchitis
- Bronchitis, Chronic
Other Study ID Numbers
- REC/RCR&AHS/23/0336
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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