ClinicalTrials.gg
CompletedNCT06242210Updated Apr 19, 2024

Effects of Pursed Lip Breathing Technique Versus Stacked Breathing Technique Among Chronic Bronchitis Patients

An interventional study of pursed lip and Stacked Breathing in Chronic Bronchitis, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-04-19.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Chronic Bronchitis

Keywords

  • Pursed Lip Breathing
  • Stacked Breathing
  • Dyspnea
  • Lung Volumes
03

In context

Bronchitis, Chronic

209 studies on the registry are indexed under Bronchitis, Chronic; 14 are open to participants now.

This study's enrollment of 34 is below the median of 101 across 154 interventional studies indexed under Bronchitis, Chronic.

Browse Bronchitis, Chronic studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,193 studies on the registry; 650 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and anabolic steroid from previous three months.
  • Patients do not experience severe obstruction of airflow i.e.: value of is at 50% of the predicted value.
  • Patients have no history or persistence of COVID-19

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
34 participants (actual)

Study arms

  • 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.

    Other: pursed lip

  • 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

    Other: Stacked Breathing

Interventions

  • Otherpursed lip

    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

  • OtherStacked Breathing

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline and fourth week

  2. 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

    Time frame: baseline and fourth week

  3. 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

    Time frame: baseline and fourth week

  4. 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

    Time frame: baseline and fourth week

07

Study locations

1 site
  • Sheikh Zayed Hospital,
    Lahore, Punjab 54000, Pakistan
08

References and documents

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 36462509 ↗
  • 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. PubMed 36902641 ↗
  • 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. PubMed 35198625 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06242210
Responsible party
Sponsor
First posted
Feb 5, 2024
Start date
Jan 5, 2024
Primary completion
Mar 15, 2024
Completion
Apr 15, 2024
Last update
Apr 19, 2024

Study contacts

Madiha Younis, MSPT (CP)
principal investigator · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion