To compare the effects of rib cage mobilization and diaphragmatic breathing on lung function in patients with COPD.
Design
Randomize clinical trial, not blind trial, 2 group.
Settings and conduct
Idrees teaching hospital Sialkot Cantt, Allama Iqbal memorial hospital Sialkot, Chest and gynae hospital Sialkot. The study was conducted within 6 months after the approval of synopsis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: •Age 40 to 70 years, at least history of chronic obstructive pulmonary disease from 1 year •Altered dyspnea index •Decrease FEV1/FVC •chronic obstructive pulmonary disease Grade II and III Exclusion criteria: •Acute exacerbation of chronic obstructive pulmonary disease •Grade IV chronic obstructive pulmonary disease patients. •Patients with comorbidities •Patient in any life-threatening condition.
Intervention groups
Group A: Rib cage mobilization, postural drainage, breathing exercises(expiratory)
Group B: diaphragmatic breathing, postural drainage, breathing exercises(expiratory)
Pre interventional readings will be taken at baseline & post interventional readings at 6 weeks
Main outcome variables
level of dyspnea(Dyspnea index) and FEV1/FVC ratio (Spirometer)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210108049966N2
Registration date:2022-07-27, 1401/05/05
Registration timing:retrospective
Last update:2022-07-27, 1401/05/05
Update count:0
Registration date
2022-07-27, 1401/05/05
Registrant information
Name
Shanza Tanveer
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 48 3215215
Email address
cheematanvir666@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-20, 1400/12/29
Expected recruitment end date
2022-04-25, 1401/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of rib cage mobilization and diaphragmatic breathing on lung function in patients with COPD
Public title
Comparison of rib cage mobilization and diaphragmatic breathing on lung function in patients with COPD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40 to 70 years, at least history of chronic obstructive pulmonary disease from 1 year
Altered dyspnea index
DecreaseFEV1/FVC
Exclusion criteria:
Acute exacerbation of chronic obstructive pulmonary disease
Patient in any life-threatening condition.
Patients with comorbidities
Grade IV COPD patients.
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done through sealed envelope method on sample size of 22 individuals selected on inclusion & exclusion criteria in order to minimize biasness. Written informed consent will be taken. Lottary method will be used for allocation. Number of chits will be equal to total sample size, odd numbers for Group A allocation and even numbers for group B allocation.Each patient will be requested to draw a chit from the box.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Riphah International University
Street address
28- M Quaid e Azam Industrial Estate, Kot Lakhpat, Lahore.
City
lahore
Postal code
54000
Approval date
2022-05-01, 1401/02/11
Ethics committee reference number
RCR/RCR & AHS/20/021
Health conditions studied
1
Description of health condition studied
Chronic obstructive pulmonary disease, or COPD, refers to a group of diseases that cause airflow blockage and breathing-related problems.Shortness of breath known medically as dyspnea is often described as an intense tightening in the chest, air hunger, difficulty breathing, breathlessness or a feeling of suffocation. The FEV1/FVC ratio is the amount of air exhaled in the first second divided by all of the air exhaled during a maximal exhalation.
Intervention group: group-A= Rib cage mobilization was applied in group A for 3 weeks at 5 days per week in three different positions, in sitting, side lying for ribs 10th to 2nd, and supine lying for 1st rib.
Category
Treatment - Other
2
Description
Intervention group: group-B= The deep breathing exercises were applied in group B for 3 weeks at 5 days per week in sitting position.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Idrees teaching hospital Sialkot Cantt, Allama Iqbal memorial hospital Sialkot, Chest and gynae hosp
Full name of responsible person
Husna Haider
Street address
House no.1 block A muhafiz town, Sargodha
City
Sargodha
Postal code
40100
Phone
+92 304 7924564
Email
cheematanvir666@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University Lahore, Pakistan
Full name of responsible person
Husna Haider
Street address
House no.1 block A muhafiz town, Sargodha.
City
Sargodha
Postal code
40100
Phone
+92 48 3215215
Email
cheematanvir666@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University Lahore, Pakistan
Proportion provided by this source
100
Public or private sector
Private
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, Pakistan
Full name of responsible person
Husna Haider
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House no.1 block A muhafiz town, Sargodha.
City
Sargodha
Province
Punjab
Postal code
40100
Phone
+92 48 3215215
Email
cheematanvir666@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah College of Rehabilitation Sciences (RCRS)
Full name of responsible person
Husna Haider
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House no.1 block A muhafiz town, Sargodha.
City
sargodha
Province
punjab
Postal code
40100
Phone
+92 48 3215215
Email
cheematanvir666@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah College of Rehabilitation Sciences (RCRS)
Full name of responsible person
Husna Haider
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House no.1 block A muhafiz town, Sargodha.
City
Sargodha
Province
Punjab
Postal code
40100
Phone
+92 48 3215215
Email
cheematanvir666@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
There is no further decision & information is decided yet.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available