Chronic BronchitisNCT06242210
Effects of Pursed Lip Breathing Technique Versus Stacked Breathing Technique Among Chronic Bronchitis Patients
A study testing pursed lip and Stacked Breathing in people with Chronic Bronchitis, run by Riphah International University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Chronic Bronchitis
- What is being tested?
- pursed lip and Stacked Breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jan 2024to 15 Apr 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Bronchitis
- Being tested
- pursed lip, Stacked Breathing
- Keywords
- Pursed Lip Breathing, Stacked Breathing, Dyspnea, Lung Volumes
- Medical subject headings
- Bronchitis, Chronic, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pursed lipOther
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
Stacked BreathingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Pursed Lip Breathing Technique | Experimental | 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. Receives: Other: pursed lip |
| Stacked Breathing | Experimental | 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 Receives: Other: Stacked Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Borg Scale
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
Measured: baseline and fourth week
Spirometer
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
Measured: baseline and fourth week
Pulse Oximeter
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
Measured: baseline and fourth week
European Quality of Life; 5 Dimensions, 5 Levels Questionnaire
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
Measured: baseline and fourth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start5 Jan 2024
- Primary completion15 Mar 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic BronchitisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Madiha Younis, MSPT (CP), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242210
- Sponsor's protocol ID
- REC/RCR&AHS/23/0336
- Status last verified
- Apr 2024
- First submitted
- 28 Jan 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36462509Mayr 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.
PubMed 36902641Satia 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.
PubMed 35198625
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pursed Lip Breathing Technique Versus Stacked Breathing Technique on Dyspnea, Lung Volumes, Oxygenation, and Quality of Life Among Chronic Bronchitis Patients
- ClinicalTrials.gov ID
- NCT06242210
- Acronym / sponsor ID
- REC/RCR&AHS/23/0336
- Conditions
- Chronic Bronchitis
- Keywords
- Pursed Lip Breathing, Stacked Breathing, Dyspnea, Lung Volumes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 5 Feb 2024 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pursed Lip Breathing Technique | Experimental | Other: pursed lipPatient 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. |
| Stacked Breathing | Experimental | Other: Stacked BreathingPatient 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 |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- • Any recent thoracic surgeries and abdominal surgeries.
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 lippursed 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 | Other | Pursed Lip Breathing Technique |
| Stacked BreathingThe 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 | Other | Stacked Breathing |
Primary outcome
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
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
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
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
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 19 Apr 2024.
- Background: PubMed 36462509Venkatesan 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.
- Background: PubMed 36902641Mayr 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.
- Background: PubMed 35198625Satia 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.
- 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.
Madiha Younis, MSPT (CP) 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 and Stacked Breathing in people with Chronic Bronchitis, 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 7 inclusion and 7 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 19 Apr 2024. 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?
Modified Borg Scale (time frame: baseline and fourth week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06242210, which also lists 3 linked publications.
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 19 Apr 2024.