NCT06460610

Brief 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. 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

June 11, 2024

Last Update Submit

July 15, 2024

Conditions

Keywords

blow bottleacapelladiaphragmatic breathingPneumonia

Outcome Measures

Primary Outcomes (3)

  • Pulse Oximeter

    Pulse oximetry is a noninvasive test that measures the oxygen saturation level of your blood

    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.

    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)

    baseline and fourth week

Study Arms (2)

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.

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

Other: Acapella along with Diaphragmatic Breathing

Interventions

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

Blow Bottle technique

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

(Acapella along with Diaphragmatic Breathing)

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients in the acute pneumonia
  • Age40-60 years.
  • Both male and female
  • Patients with unstable health conditions
  • Participants were willing to participate

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (2)

  • 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.

    PMID: 30706119BACKGROUND
  • 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.

    PMID: 29767563BACKGROUND

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sidra Afzal, PP-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 14, 2024

Study Start

January 15, 2024

Primary Completion

July 15, 2024

Study Completion

July 15, 2024

Last Updated

July 16, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations