- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04928729
Dose Response of Pursed Lip Breathing With Diaphragmatic Breathing On Pulmonary Functions in Patients With COPD
- To determine the Effects of combined pursed lip breathing with diaphragmatic breathing on pulmonary functions in patient with COPD.
- To determine the different durations of combined pursed lip breathing with diaphragmatic breathing on Pulmonary functions in patient with COPD.
- To determine the Effects of combined pursed lip breathing with diaphragmatic breathing on quality of life in patient with COPD
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The technique of pursed lip breathing allow the patients to control the oxygenation and ventilation. This technique is performed by allowing the person to inspire through the nose exhale through the mouth at a slow controlled flow. This technique works by moving oxygen into your lungs and carbon dioxide out of your lungs. Pursed lip breathing (PLB) helps to slow down breathing rate and relieving shortness of breath by keeping the airways open longer. So patients can remove the air that is trapped in to the lungs.
In a recent systematic review that is published in 2018, PLB was shown to significantly improve ventilation related outcomes such as respiratory rate and minute ventilation, but not dyspnea and exercise capacity.
Diaphragmatic breathing (DB), that is also called deep breathing, this breathing is done by contracting the diaphragm, a muscle located horizontally between the thoracic cavity and abdominal cavity. During this type of breathing, air enters in to the lungs, the chest does not rise and belly expands. Diaphragmatic breathing encourages fully oxygen exchange, that is the beneficial trade of incoming oxygen for out going carbon dioxide.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Dera Ghazi Khan, Punjab, Pakistan
- Pulmonology Department of DHQ Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants were diagnosed as COPD
- The intervention PLB Combine with DB
- Stable COPD Patients (Mild and Moderate on GOLD criteria) Global Initiative for Chronic Obstructive Lung Disease (GOLD)
Exclusion Criteria:
- Patients with other Pulmonary diseases.
- cardiovascular, neurological and orthopedic diseases
- Obesity, history of recent exacerbation
- Uncontrolled arterial hypertension
- Any surgical complications
- Patients with ventilatory support
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pursed Lip Breathing
|
PLB with frequency of three times daily for First 3 days of week for a duration of 5-10 mins is perform.
|
|
Experimental: Pursed Lip Breathing +DB
|
PLB+DB with frequency of three times daily for Last three days of week for a duration of 10-15 mins is perform.
|
|
Experimental: Conservative care
|
Participants will be having different dose as per tolerance 5 times daily.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Borg Scale of Perceived Exertion
Time Frame: 6th week
|
Changes from the Baseline, It is a subjective numeric scale ranging from 0 to 10, where 0 indicates "no dyspnea" and 10 indicates "unbearable dyspnea."
A number is chosen by the patient in order to decide the best score that matches his level of dyspnea during physical activity.
|
6th week
|
|
Forced Expiratory Volume in 1 second (FEV1)
Time Frame: 6th week
|
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
|
6th week
|
|
6 min walk test: Distance (meters)
Time Frame: 6th week
|
Changes from the baseline, 6 min walk test was used to measure Functional capacity.
It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min without any support.
|
6th week
|
|
Peak Expiratory Flow (PEF)
Time Frame: 6th Week
|
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
|
6th Week
|
|
COPD Assessment Test (CAT)
Time Frame: 6th week
|
The COPD Assessment Test (CAT) is a questionnaire for patients with chronic obstructive pulmonary disease (COPD), which can be filled in to quantify their symptoms in the form of scores (0-40).
Changes From the Baseline will be Assessed.
It is categorized into four groups, that are, low(1) , medium(2), high(3) and very high(4) based on the level of effect of the disease on status of health.
|
6th week
|
|
Forced vital Capacity (FVC)
Time Frame: 6th Week
|
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters.
|
6th Week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/00879 Tayyaba Kanwal
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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