Protocol summary

Study aim
To compare the effects of autogenic drainage and active cycle of breathing in pneumonia patients .
Design
In this RCT study, 16 individuals will be divided into 2 groups, interventional group 1 and interventional group 2 by Convenient sampling technique with parallel group design, enrolled between June 2021 and December 2021.
Settings and conduct
This RCT study will be conducted in Gulab Devi Hospital, Lahore, Pakistan. 16 individuals will b equally divided into 2 groups that are selected by Convenient sampling technique. We will randomly select patients, visiting Gulab Devi Hospital, that are easy to select.
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA: • Patients aged 35- 60 years with • PNEUMONIA SEVERITY INDEX (PORT SCORE) • CLASS I TO III • Moderate to severe Grades for Severity of a Pulmonary Function Test Abnormality EXCLUSION CRITERIA: • Patients with secondary pneumonia-that is, as a complication of dysfunction of respiratory muscles, • Chronic bronchitis, • Emphysema, or • Asthma • Patients with known pulmonary tuberculosis or lung cancer • Intellectually impaired
Intervention groups
In this study the sample size is 16, and is divided into 2 groups. Intervention group 1 and interventional group 2. Each group contain 8 individuals. Interventional group 1 will receive autogenic drainage along with percussion. Intervention group 2 will be given active cycle breathing technique along with percussion.
Main outcome variables
forced expiratory volume (FEV) forced 1 vital capacity (FVC) peak expiratory flow rate (PEFR) The oxygen hemoglobin saturation (SpO2)

General information

Reason for update
Acronym
nil
IRCT registration information
IRCT registration number: IRCT20220111053693N1
Registration date: 2022-01-21, 1400/11/01
Registration timing: retrospective

Last update: 2022-01-21, 1400/11/01
Update count: 0
Registration date
2022-01-21, 1400/11/01
Registrant information
Name
Azed Ahsaan
Name of organization / entity
Riphah international university lahore
Country
Pakistan
Phone
+92 335 6055553
Email address
azedahsaan786@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-05, 1400/03/15
Expected recruitment end date
2021-12-25, 1400/10/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Of Autogenic Drainage & Active Cycle Of Breathing Techniques In Patients With Pneumonia
Public title
Comparison Of Autogenic Drainage & Active Cycle Of Breathing Techniques In Patients With Pneumonia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 35- 60 years. PNEUMONIA SEVERITY INDEX (PORT SCORE) CLASS I TO III Moderate to severe Grades for Severity of a Pulmonary Function Test Abnormality
Exclusion criteria:
Patients with secondary pneumonia-that is, as a complication of dysfunction of respiratory muscles, Chronic bronchitis, Emphysema, Asthma Patients with known pulmonary tuberculosis or lung cancer. Intellectually impaired
Age
From 35 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 16
Randomization (investigator's opinion)
Randomized
Randomization description
This study was conducted at Gulab Devi Chest Hospital Lahore, Pakistan. This study was randomized clinical trial. Total twenty subjects were assigned randomly by using Convenient sampling technique into two groups. we will randomly choose the patients who will visit the hospital, having pneumonia and those who will meet our inclusion criteria. These patients will be allocated in 2 groups according to our convivence.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
nil

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Riphah Ethical Committee
Street address
Township Lahore
City
Lahore
Postal code
42000
Approval date
2021-03-19, 1399/12/29
Ethics committee reference number
21985

Health conditions studied

1

Description of health condition studied
Pneumonia is inflammation of the lungs and fluid collection in the alveoli. The two most common organisms responsible for pneumonia in low‐income countries are Streptococcus pneumoniae and Haemophilus influenzae . Children with pneumonia are treated with antibiotics, with hospitalisation and oxygen supplementation required in some cases, depending on disease severity. Accumulation of secretions in the airways due to respiratory infection contributes to the worsening of clinical symptoms and leads to an increase in airway resistance with each breath Signs and symptoms that are useful in diagnosing pneumonia are fever, tachypnoea, nasal flaring, cough, breathlessness, lower chest wall indrawing, and reduced oxygen saturation The gold standard for diagnosing pneumonia according to clinical guidelines is the presence of lung infiltrates indicated by chest radiography.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Forced Vital Capacity (FVC)
Timepoint
Measurements will be repeated after 4 weeks of 1st intervention.
Method of measurement
The pulmonary function variables which will be assessed would be the Forced Vital Capacity (FVC) with the use of a spirometer. A brief description about the assessment procedure including technical steps to obtain pulmonary function data and variables will be explained to each subject. After 2–3 tidal breaths, subjects will be asked to inhale deeply to total lung capacity and then immediately exhale rapidly (without any pause) through a disposable mouthpiece until as much air as possible has been expelled from the lungs. The test will be performed with each subject in in high sitting position. The assessment will be repeated 3 times after adequate rest. The average values of the forced vital capacity (FVC) will be recorded.

2

Description
Forced Expiratory Volume in one second (FEV1)
Timepoint
Measurements will be repeated after 4 weeks of 1st intervention.
Method of measurement
The pulmonary function variables which will be assessed would be the Forced Expiratory Volume in one second (FEV1) with the use of a spirometer. A brief description about the assessment procedure including technical steps to obtain pulmonary function data and variables will be explained to each subject. After 2–3 tidal breaths, subjects will be asked to inhale deeply to total lung capacity and then immediately exhale rapidly (without any pause) through a disposable mouthpiece until as much air as possible has been expelled from the lungs. The test will be performed with each subject in in high sitting position. The assessment will be repeated 3 times after adequate rest. The average values of forced expiratory volume in the first second (FEV1) will be recorded.

Secondary outcomes

1

Description
The oxygen hemoglobin saturation (SpO2).
Timepoint
Measurements will be repeated after 4 weeks of 1st intervention.
Method of measurement
The oxygen hemoglobin saturation (SpO2) will be assessed using a non-invasive pulse oximeter.

Intervention groups

1

Description
In this study the sample size is 16, and is divided into 2 groups. Intervention group 1 and interventional group 2. Each group contain 8 individuals. Interventional group 1 will receive autogenic drainage along with percussion. The autogenic drainage technique tends to be practiced in sitting, and consists of 3 phases:1. Un-sticking – this mobilizes secretions in the small airways at the bottom of the lungs. Technique: big breath out, small breath in2. Collecting – this gathers the secretions and pushes them up the lungs into the main airways. Technique: middle sized breaths in and out3. Evacuating – this gets the secretions right to the back of the throat where they can be coughed out easily. Coughing before this phase is discouraged. Technique: take in as much air as possible then slowly sigh out. Gentle active huffs then used to remove the secretions from the body through the mouth.
Category
Rehabilitation

2

Description
Intervention group 2 will be given active cycle breathing technique along with percussion. Active cycle breathing technique consists of 4 stages:1. Breathing control – This is gentle breathing to allow you to relax and concentrate. With your hands gently resting on your tummy, concentrate on feeling your tummy rise and fall with each gentle breath in and out. Your breath out should be slow, almost like a sigh.2. Thoracic expansion (deep breaths) – This gets the air right down to the bottom of the lungs where it can loosen the phlegm. The breath in through your nose should be nice and slow, you should be able to feel your lungs filling up, when you feel like you have as much air in as is possible I want you to hold it there just for a few seconds, then gently breathe out through your mouth nice and slowly.3. Forced expiration (huff) – This helps force the phlegm up and out of your lungs. To carry out the technique effectively you need to pretend you have a mirror in front of you; take a normal breath in then huff the air out as if you are steaming up the mirror. This sometimes causes an acute onset of coughing.4. Cough – This allows you to get the phlegm up and out of your mouth, coughs are tiring and so should only be completed when you feel like the phlegm is just in the back of your throat. If the technique is used following surgery, a towel can be held over the scar site to ease the pressure on the wound and reduce pain whilst coughing
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Gulab Devi Hospital Lahore, Pakistan
Full name of responsible person
Azed Ahsaan
Street address
Ward no 14, Near HBL Bank, Jampur, District Rajanpur, Pakistan
City
Lahore
Postal code
42000
Phone
+92 335 6055553
Email
azedahsaan786@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University , Lahore, Pakistan
Full name of responsible person
Qurat Ul Ain
Street address
28 M, Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore, Pakistan
City
Lahore
Postal code
42000
Phone
+92 42 111 747 424
Email
azedahsaan786@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Riphah University
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Riphah international university lahore
Full name of responsible person
Azed Ahsaan
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Ward no 14 near ubl bank jampur district Rajanpur
City
Jampur
Province
Punjab
Postal code
33500
Phone
+92 335 6055553
Fax
Email
azedahsaan786@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah international university lahore
Full name of responsible person
Azed Ahsaan
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Ward no 14 near ubl bank jampur district Rajanpur
City
Jampur
Province
Punjab
Postal code
33500
Phone
+92 335 6055553
Fax
Email
azedahsaan786@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Riphah international university lahore
Full name of responsible person
Azed Ahsaan
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Ward no 14 near ubl bank jampur district Rajanpur
City
Jampur
Province
Punjab
Postal code
33500
Phone
+92 335 6055553
Fax
Email
azedahsaan786@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
nil
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
nil
When the data will become available and for how long
nil
To whom data/document is available
nil
Under which criteria data/document could be used
nil
From where data/document is obtainable
nil
What processes are involved for a request to access data/document
nil
Comments
nil
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