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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Blow Bottle technique
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
Other: Acapella along with Diaphragmatic Breathing
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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