To compare the effects of incentive spirometry (IS) and deep breathing exercises (DBE) on pulmonary functions after coronary artery bypass grafting
Design
Pragmatic, community based, parallel-group, double-blind, randomised controlled trial
Settings and conduct
Conducted from July, 2019 - January, 2020 in Doctor's hospital Lahore
Assesor was kept blind
Participants/Inclusion and exclusion criteria
CABG patients of either gender, aged between 35-60 years were selected by taking 20 in each group by convenient sampling. Patients with previous history of lung disorder, bone tuberculosis, osteoarthritis, neurological diseases and osteoporosis patients, chest operative and unstable hemodynamics patients were debarred.
Intervention groups
Group-A with 20 patients was handled with incentive spirometry only. Group-B comprised of 20 patients was treated with deep breathing exercises.
Main outcome variables
The outcome measures are values of oxygen saturation (SaO2)by pulse oximetry, and partial pressures of oxygen (pO2) and carbon dioxide (pCO2) measured by arterial blood gases (ABGs).
General information
Reason for update
Acronym
EISDBEPFCABG
IRCT registration information
IRCT registration number:IRCT20200204046373N2
Registration date:2021-10-20, 1400/07/28
Registration timing:retrospective
Last update:2021-10-20, 1400/07/28
Update count:0
Registration date
2021-10-20, 1400/07/28
Registrant information
Name
Arooj Fatima
Name of organization / entity
The University Of Lahore
Country
Pakistan
Phone
+92 42 35414221
Email address
aruj43@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-01, 1398/04/10
Expected recruitment end date
2020-01-05, 1398/10/15
Actual recruitment start date
2019-07-01, 1398/04/10
Actual recruitment end date
2020-01-05, 1398/10/15
Trial completion date
2020-01-05, 1398/10/15
Scientific title
Effects of incentive spirometry and deep breathing exercises on pulmonary functions after coronary artery bypass grafting
Public title
Physiotherapy techniques in post-CABG patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Post-CABG patients
aged between 35-60 years
Both gender
Exclusion criteria:
Patients with previous history of lung disorder
bone tuberculosis
osteoarthritis
neurological diseases
osteoporosis patients
unstable hemodynamics
Age
From 35 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization was applied.
Individual unit of randomization
Parallel-group, concealed envelop method used
Subjects were randomly allocated to both groups based on a computer-generated randomized design. The randomization allocation was sealed in opaque envelopes, and the clinical coordinator did not know about the group to which the subject would be assigned until the envelopes were opened.
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessors and statisticians were blinded until the completion of the study.
They were not aware of the interventions and groups. Concealed opaque envelopes were used for group assignment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board Committee
Street address
1 km, Bhobatiyan chowk, Defence road
City
Lahore
Postal code
5400
Approval date
2019-06-01, 1398/03/11
Ethics committee reference number
IRB-UOL-FAHS/600/2019
Health conditions studied
1
Description of health condition studied
Rotator cuff tendinopathy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
oxygen saturation (SaO2)
Timepoint
Day 1 and day 4 after CABG surgery
Method of measurement
The outcome measures are values of oxygen saturation (SaO2)by pulse oximetry
Secondary outcomes
1
Description
oxygen saturation
Timepoint
Day 1 and day 4 after CABG surgery
Method of measurement
measured by pulse oximetry
Intervention groups
1
Description
Intervention group: It received incentive spirometry in addition to routine physical therapy. Control group: It received deep breathing exercises along with routine physical therapy. About 2000 shockwaves of 0.32mJ/mm2per treatment were given as 10 sessions for the first six weeks(two sessions/week). The regions of tendinopathy were identified by the US, and the corresponding surfaces of the regions were marked. ESWT was conducted using a ShockMaster 500 device (GymnaUniphy NV, Bilzen, Belgium)twice a week for six weeks in total. Each treatment consisted of 2000 shocks with a frequency of 120 shocks per minute. Each ESWTsession took about 15-20 minutes. ESWT application was performed on the supraspinatus, infraspinatus, teres minor, and subscapularis tendons. In successive treatments, an energy density of 0.32mJ/mm2 was used. An isotonic gel was used as an intermediate before the probe was applied to the patient’s shoulder, and no local anaesthetic was used.
Category
Rehabilitation
2
Description
Control group: Routine treatment was administered to the patients in both experimental and RPT groups and it included these items: general exercise plan included ROM exercises, stretching, and strengthening exercises of abductors and flexors of the shoulder) performed twice a week in 10 sessions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Doctor's Hospital Lahore
Full name of responsible person
Dr. Seema
Street address
1 km, Bhobatiyan chowk, Defence road
City
Lahore
Postal code
5400
Phone
Email
aruj43@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Arooj Fatima
Street address
1 km, Bhobatiyan chowk, Defence road
City
Lahore
Postal code
5400
Phone
+92 42 35422636
Email
arooj.fatima1@uipt.uol.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Lahore
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Arooj Fatima
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
1 km, Bhobatiyan chowk, Defence road
City
Lahore
Province
Punjab
Postal code
5400
Phone
092 42 341 4391882
Email
arooj.fatima1@uipt.uol.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Arooj Fatima
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
1 km, Bhobatiyan chowk, Defence road
City
Lahore
Province
Punjab
Postal code
5400
Phone
092 42 341 4391882
Email
arooj.fatima1@uipt.uol.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Arooj Fatima
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
1 km, Bhobatiyan chowk, Defence road
City
Lahore
Province
Punjab
Postal code
5400
Phone
092 42 3414391882
Email
arooj.fatima1@uipt.uol.edu.pk
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
will be available on request
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data sets
When the data will become available and for how long
On request
To whom data/document is available
journals
Under which criteria data/document could be used
through mail
From where data/document is obtainable
From author, aruj43@hotmail.com
What processes are involved for a request to access data/document