PneumoniaNCT06460610
Comparative Effects of Blow Bottle and Acapella Along With Diaphragmatic Breathing in Patients With Pneumonia
A study testing Blow Bottle technique and Acapella along with Diaphragmatic Breathing in people with Pneumonia, run by Riphah International University at 1 site in Pakistan.
Trial summary
Pneumonia is the inflammation of lung parenchyma involving lungs alveoli and is a leading cause of lower respiratory tract infections and deaths around the globe and the number rises greatly after the Covid-19 pandemic. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumonia
- What is being tested?
- Blow Bottle technique and Acapella along with Diaphragmatic Breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2024to 15 Jul 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients in the acute pneumonia
- Age40-60 years.
- Both male and female
- Patients with unstable health conditions
- Participants were willing to participate
Who cannot join
- Patients with physical or cognitive limitations.
- Patients with a history of chronic respiratory conditions such as COPD, bronchitis, or asthma
- Pregnant or breastfeeding women. Individuals with musculoskeletal or neurological conditions
- Patients with contraindications to chest percussion therapy, such as recent surgery or trauma to the chest area.
- Patients with severe Pneumonia requiring immediate care
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Jinnah hospital Lahore
Lahore, Punjab Province, 54000
Sidra Afzal, PP-DPT, 03124378540, sidra.afzal@riphah.edu.pk
About this study
Pneumonia is the inflammation of lung parenchyma involving lungs alveoli and is a leading cause of lower respiratory tract infections and deaths around the globe and the number rises greatly after the Covid-19 pandemic. The Symptoms of Pneumonia is cough, fever, dyspnea, myalgia, altered blood gas ratio, and mental alteration. Treatment and management of this disease varies from patient to patient according to its severity stages .Blow Bottle supports the patient to remove excess secretions to increase pressure in the airways. This opens up the passageways in bronchioles, air behind the mucus push it into the larger airways .It will be easy to remove mucus by coughing or huffing. Hypoximia is a clinical feature of Pneumonia that requires a fraction of inspired oxygen FiO2 of 0.50 to maintain an oxygen saturation of 92%. This research of randomized clinical trial will check the comparative effects of Blow Bottle Technique and Acapella along with Diaphragmatic Breathing in patients with Pneumonia by taking sample of 50 patients through Non Probability convenience sampling and randomly allocating them to two groups A and B out of which A will receive both Blow Bottle and Diaphragmatic Breathing training, B will receive Acapella with Diaphragmatic Breathing upto the duration of 3 days per week for upto 4 weeks. Pre and post training outcomes of pulmonary function will be measured through BCSS ,Oxygen Saturation through Pulse Oximeter, and disease severity through Pneumonia severity index, and Who QOL questionnaire. The data will be analyzed through SPSS 21
- Conditions
- Pneumonia
- Being tested
- Blow Bottle technique, Acapella along with Diaphragmatic Breathing
- Keywords
- blow bottle, acapella, diaphragmatic breathing, Pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blow Bottle techniqueOther
Patients sit at a table with comfortable position Hold the bottle with one hand and the tube with the other Put the tube in mouth by holding lips firmly Breath in through nose and out through mouth Blowing enough water is bubbled Short Breaks for 2 to 3 mints When mucus rises up get out of it by coughing or huffing
Acapella along with Diaphragmatic BreathingOther
Device which uses a counter weighted plug and magnet to create airway oscillations Acapella combines the effects of PEP therapy and airway vibrations and mobilize to clear pulmonary secretions Facilitates opening of airways in patients with lung disease. Patients instructions to close the mouth piece making surety to no leakage of air. Take a long breath in nose and blow out through the Acapella ,feel vibrations on chest. Duration of performing this technique 3 days a week for 20 mints per day, 4 weeks regular
| Study group | Role | What they receive |
|---|---|---|
| Blow Bottle technique | Experimental | Blow Bottle Technique will be performed to emphasizing deep diaphragmatic breathing and controlled exhalation. Blow Bottle sessions for up to 20 minutes per day for 3 days in a week .Total 12 sessions in 4 weeks. Receives: Other: Blow Bottle technique |
| (Acapella along with Diaphragmatic Breathing) | Active comparator | Acapella will be performed to Improves clearance of secretion to facilitates opening of airway in patients with lung disease to mobilize secretions and improve lung function. Daily session for 20 minutes per day for 3 days in a week. Total 12 sessions in 4 weeks Receives: Other: Acapella along with Diaphragmatic Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Oximeter
Pulse oximetry is a noninvasive test that measures the oxygen saturation level of your blood
Measured: baseline and fourth week
Who QOL Questionnaire
Quality of life Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale The physical health domain includes items on mobility, daily activities, functional capacity, energy, pain, and sleep.
Measured: baseline and fourth week
Breathlessness, Cough and Sputum Scale
The Breathlessness, Cough and Sputum Scale (BCSS) is used to predict patient exacerbations by evaluating common symptoms identified in the COPD population. The BCSS have 24 items concerning beliefs about the self and others that are assessed on a five-point rating scale (0-4).Four scores are obtained: negative-self (six items), positiveself (six items), negative-others (six items) and positive-others (six items)
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 posted14 Jun 2024
- Study start15 Jan 2024
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Afzal, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460610
- Sponsor's protocol ID
- REC/RCR&AHS/23/0383
- Status last verified
- Jul 2024
- First submitted
- 11 Jun 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Torres A, Chalmers JD, Dela Cruz CS, Dominedo C, Kollef M, Martin-Loeches I, Niederman M, Wunderink RG. Challenges in severe community-acquired pneumonia: a point-of-view review. Intensive Care Med. 2019 Feb;45(2):159-171. doi: 10.1007/s00134-019-05519-y. Epub 2019 Jan 31.
PubMed 30706119Quinton LJ, Walkey AJ, Mizgerd JP. Integrative Physiology of Pneumonia. Physiol Rev. 2018 Jul 1;98(3):1417-1464. doi: 10.1152/physrev.00032.2017.
PubMed 29767563
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Blow Bottle and Acapella Along With Diaphragmatic Breathing in Patients With Pneumonia
- ClinicalTrials.gov ID
- NCT06460610
- Acronym / sponsor ID
- REC/RCR&AHS/23/0383
- Conditions
- Pneumonia
- Keywords
- blow bottle, acapella, diaphragmatic breathing, Pneumonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 14 Jun 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.
Pneumonia is the inflammation of lung parenchyma involving lungs alveoli and is a leading cause of lower respiratory tract infections and deaths around the globe and the number rises greatly after the Covid-19 pandemic. The Symptoms of Pneumonia is cough, fever, dyspnea, myalgia, altered blood gas ratio, and mental alteration. Treatment and management of this disease varies from patient to patient according to its severity stages .Blow Bottle supports the patient to remove excess secretions to increase pressure in the airways. This opens up the passageways in bronchioles, air behind the mucus push it into the larger airways .It will be easy to remove mucus by coughing or huffing. Hypoximia is a clinical feature of Pneumonia that requires a fraction of inspired oxygen FiO2 of 0.50 to maintain an oxygen saturation of 92%. This research of randomized clinical trial will check the comparative effects of Blow Bottle Technique and Acapella along with Diaphragmatic Breathing in patients with Pneumonia by taking sample of 50 patients through Non Probability convenience sampling and randomly allocating them to two groups A and B out of which A will receive both Blow Bottle and Diaphragmatic Breathing training, B will receive Acapella with Diaphragmatic Breathing upto the duration of 3 days per week for upto 4 weeks. Pre and post training outcomes of pulmonary function will be measured through BCSS ,Oxygen Saturation through Pulse Oximeter, and disease severity through Pneumonia severity index, and Who QOL questionnaire. The data will be analyzed through SPSS 21
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blow Bottle technique | Experimental | Other: Blow Bottle techniqueBlow Bottle Technique will be performed to emphasizing deep diaphragmatic breathing and controlled exhalation. Blow Bottle sessions for up to 20 minutes per day for 3 days in a week .Total 12 sessions in 4 weeks. |
| (Acapella along with Diaphragmatic Breathing) | Active comparator | Other: Acapella along with Diaphragmatic BreathingAcapella will be performed to Improves clearance of secretion to facilitates opening of airway in patients with lung disease to mobilize secretions and improve lung function. Daily session for 20 minutes per day for 3 days in a week. Total 12 sessions in 4 weeks |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients in the acute pneumonia
- Age40-60 years.
- Both male and female
- Patients with unstable health conditions
- Participants were willing to participate
Key exclusion criteria (5 listed)
- Patients with physical or cognitive limitations.
- Patients with a history of chronic respiratory conditions such as COPD, bronchitis, or asthma
- Pregnant or breastfeeding women. Individuals with musculoskeletal or neurological conditions
- Patients with contraindications to chest percussion therapy, such as recent surgery or trauma to the chest area.
- Patients with severe Pneumonia requiring immediate care
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 |
|---|---|---|
| Blow Bottle techniquePatients sit at a table with comfortable position Hold the bottle with one hand and the tube with the other Put the tube in mouth by holding lips firmly Breath in through nose and out through mouth Blowing enough water is bubbled Short Breaks for 2 to 3 mints When mucus rises up get out of it by coughing or huffing | Other | Blow Bottle technique |
| Acapella along with Diaphragmatic BreathingDevice which uses a counter weighted plug and magnet to create airway oscillations Acapella combines the effects of PEP therapy and airway vibrations and mobilize to clear pulmonary secretions Facilitates opening of airways in patients with lung disease. Patients instructions to close the mouth piece making surety to no leakage of air. Take a long breath in nose and blow out through the Acapella ,feel vibrations on chest. Duration of performing this technique 3 days a week for 20 mints per day, 4 weeks regular | Other | (Acapella along with Diaphragmatic Breathing) |
Primary outcome
Pulse Oximeter
Time frame: baseline and fourth week
Pulse oximetry is a noninvasive test that measures the oxygen saturation level of your blood
Who QOL Questionnaire
Time frame: baseline and fourth week
Quality of life Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale The physical health domain includes items on mobility, daily activities, functional capacity, energy, pain, and sleep.
Breathlessness, Cough and Sputum Scale
Time frame: baseline and fourth week
The Breathlessness, Cough and Sputum Scale (BCSS) is used to predict patient exacerbations by evaluating common symptoms identified in the COPD population. The BCSS have 24 items concerning beliefs about the self and others that are assessed on a five-point rating scale (0-4).Four scores are obtained: negative-self (six items), positiveself (six items), negative-others (six items) and positive-others (six items)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Background: PubMed 30706119Torres A, Chalmers JD, Dela Cruz CS, Dominedo C, Kollef M, Martin-Loeches I, Niederman M, Wunderink RG. Challenges in severe community-acquired pneumonia: a point-of-view review. Intensive Care Med. 2019 Feb;45(2):159-171. doi: 10.1007/s00134-019-05519-y. Epub 2019 Jan 31.
- Background: PubMed 29767563Quinton LJ, Walkey AJ, Mizgerd JP. Integrative Physiology of Pneumonia. Physiol Rev. 2018 Jul 1;98(3):1417-1464. doi: 10.1152/physrev.00032.2017.
- 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.
Sidra Afzal, PP-DPT 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 Blow Bottle technique and Acapella along with Diaphragmatic Breathing in people with Pneumonia, 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact IQBAL TARIQ, PHD (03338236752, iqbal.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse Oximeter (time frame: baseline and fourth week). The study lists 3 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 NCT06460610, which also lists 2 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 16 Jul 2024.