COPDNCT04928729
Dose Response of Pursed Lip Breathing With Diaphragmatic Breathing On Pulmonary Functions in Patients With COPD
A study testing Pursed Lip Breathing, Pursed Lip Breathing +DB and Conservative care in people with COPD, run by Riphah International University at 1 site in Pakistan.
Trial summary
1. To determine the Effects of combined pursed lip breathing with diaphragmatic breathing on pulmonary functions in patient with COPD. 2. To determine the different durations of combined pursed lip breathing with diaphragmatic breathing on Pulmonary functions in patient with COPD. 3. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Pursed Lip Breathing, Pursed Lip Breathing +DB and Conservative care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2020to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pulmonology Department of DHQ Teaching Hospital
Dera Ghazi Khan, Punjab Province
About this study
- 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
Read the 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.
- Conditions
- COPD
- Being tested
- Pursed Lip Breathing, Pursed Lip Breathing +DB, Conservative care
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pursed Lip BreathingOther
PLB with frequency of three times daily for First 3 days of week for a duration of 5-10 mins is perform.
Pursed Lip Breathing +DBOther
PLB+DB with frequency of three times daily for Last three days of week for a duration of 10-15 mins is perform.
Conservative careOther
Participants will be having different dose as per tolerance 5 times daily.
| Study group | Role | What they receive |
|---|---|---|
| Pursed Lip Breathing | Experimental | Not described Receives: Other: Pursed Lip Breathing |
| Pursed Lip Breathing +DB | Experimental | Not described Receives: Other: Pursed Lip Breathing +DB |
| Conservative care | Experimental | Not described Receives: Other: Conservative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6th week
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
Measured: 6th week
Forced vital Capacity (FVC)
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters.
Measured: 6th Week
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.
Measured: 6th Week
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.
Measured: 6th week
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.
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start15 Oct 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Iqbal Tariq, MSCPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928729
- Sponsor's protocol ID
- REC/00879 Tayyaba Kanwal
- Status last verified
- Oct 2021
- First submitted
- 14 Jun 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response of Pursed Lip Breathing With Diaphragmatic Breathing On Pulmonary Functions in Patients With COPD
- ClinicalTrials.gov ID
- NCT04928729
- Acronym / sponsor ID
- REC/00879 Tayyaba Kanwal
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pursed Lip Breathing | Experimental | Other: Pursed Lip Breathing |
| Pursed Lip Breathing +DB | Experimental | Other: Pursed Lip Breathing +DB |
| Conservative care | Experimental | Other: Conservative care |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- Patients with other Pulmonary diseases.
- cardiovascular, neurological and orthopedic diseases
- Obesity, history of recent exacerbation
- Uncontrolled arterial hypertension
- Any surgical complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pursed Lip BreathingPLB with frequency of three times daily for First 3 days of week for a duration of 5-10 mins is perform. | Other | Pursed Lip Breathing |
| Pursed Lip Breathing +DBPLB+DB with frequency of three times daily for Last three days of week for a duration of 10-15 mins is perform. | Other | Pursed Lip Breathing +DB |
| Conservative careParticipants will be having different dose as per tolerance 5 times daily. | Other | Conservative care |
Primary outcome
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.
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
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Iqbal Tariq, MSCPPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pursed Lip Breathing, Pursed Lip Breathing +DB and Conservative care in people with COPD, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD Assessment Test (CAT) (time frame: 6th week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.