- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06460610
Comparative Effects of Blow Bottle and Acapella Along With Diaphragmatic Breathing in Patients With Pneumonia
July 15, 2024 updated by: Riphah International University
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: iqbal Tariq, phd
- Phone Number: 03338236752
- Email: iqbal.tariq@riphah.edu.pk
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Recruiting
- Jinnah Hospital Lahore
-
Contact:
- Sidra Afzal, PP-DPT
- Phone Number: 03124378540
- Email: sidra.afzal@riphah.edu.pk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Patients in the acute pneumonia
- Age40-60 years.
- Both male and female
- Patients with unstable health conditions
- Participants were willing to participate
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Blow Bottle technique
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.
|
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
|
|
Active Comparator: (Acapella along with Diaphragmatic Breathing)
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulse Oximeter
Time Frame: baseline and fourth week
|
Pulse oximetry is a noninvasive test that measures the oxygen saturation level of your blood
|
baseline and fourth week
|
|
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.
|
baseline and fourth week
|
|
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)
|
baseline and fourth week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sidra Afzal, PP-DPT, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Quinton LJ, Walkey AJ, Mizgerd JP. Integrative Physiology of Pneumonia. Physiol Rev. 2018 Jul 1;98(3):1417-1464. doi: 10.1152/physrev.00032.2017.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2024
Primary Completion (Estimated)
July 15, 2024
Study Completion (Estimated)
July 15, 2024
Study Registration Dates
First Submitted
June 11, 2024
First Submitted That Met QC Criteria
June 11, 2024
First Posted (Actual)
June 14, 2024
Study Record Updates
Last Update Posted (Actual)
July 16, 2024
Last Update Submitted That Met QC Criteria
July 15, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0383
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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