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Dose Response of Pursed Lip Breathing With Diaphragmatic Breathing On Pulmonary Functions in Patients With COPD

Primary Purpose

COPD

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Pursed Lip Breathing
Pursed Lip Breathing +DB
Conservative care
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pulmonology Department of DHQ Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Pursed Lip Breathing

Pursed Lip Breathing +DB

Conservative care

Arm Description

Outcomes

Primary Outcome Measures

COPD Assessment Test (CAT)
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.
Forced Expiratory Volume in 1 second (FEV1)
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Forced vital Capacity (FVC)
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters.
Peak Expiratory Flow (PEF)
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
6 min walk test: Distance (meters)
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.
Modified Borg Scale of Perceived Exertion
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.

Secondary Outcome Measures

Full Information

First Posted
June 14, 2021
Last Updated
October 19, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04928729
Brief Title
Dose Response of Pursed Lip Breathing With Diaphragmatic Breathing On Pulmonary Functions in Patients With COPD
Official Title
Dose Response of Pursed Lip Breathing With Diaphragmatic Breathing On Pulmonary Functions in Patients With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

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
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pursed Lip Breathing
Arm Type
Experimental
Arm Title
Pursed Lip Breathing +DB
Arm Type
Experimental
Arm Title
Conservative care
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Pursed Lip Breathing
Intervention Description
PLB with frequency of three times daily for First 3 days of week for a duration of 5-10 mins is perform.
Intervention Type
Other
Intervention Name(s)
Pursed Lip Breathing +DB
Intervention Description
PLB+DB with frequency of three times daily for Last three days of week for a duration of 10-15 mins is perform.
Intervention Type
Other
Intervention Name(s)
Conservative care
Intervention Description
Participants will be having different dose as per tolerance 5 times daily.
Primary Outcome Measure Information:
Title
COPD Assessment Test (CAT)
Description
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.
Time Frame
6th week
Title
Forced Expiratory Volume in 1 second (FEV1)
Description
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Time Frame
6th week
Title
Forced vital Capacity (FVC)
Description
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters.
Time Frame
6th Week
Title
Peak Expiratory Flow (PEF)
Description
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
Time Frame
6th Week
Title
6 min walk test: Distance (meters)
Description
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.
Time Frame
6th week
Title
Modified Borg Scale of Perceived Exertion
Description
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.
Time Frame
6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Iqbal Tariq, MSCPPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pulmonology Department of DHQ Teaching Hospital
City
Dera Ghazi Khan
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Dose Response of Pursed Lip Breathing With Diaphragmatic Breathing On Pulmonary Functions in Patients With COPD

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