Determination efficiency of the cardiac rehabilitation program after coronary artery bypass graft on respiratory characteristics in admitted patients to Dr.Heshmat educational and remedial center in Rasht city in 2018.
Design
A Clinical trial with 2 groups control and case, parallel, no blinding and randomized . with sample size: 54 patients
Settings and conduct
In the first group "rehabilitation with incentive spirometry like routine (control)" and the second group "receive CPAP with mask 4-6 cmH2o until 35 minutes (case)" besides routine. After 2 hours, progressive exercises as walking start on the first day, 5-10 minutes (base on patients tolerance), in the second day 10-15 minutes and in the third day 15 minutes and more. At the end of each session, all of the patients will evaluate with modified Borg scale CR-10 for dyspnea and RPE scale for leg effort. In the fourth day, the final results will evaluate with spirometry parameters. Location of sampling: heart surgery ward in Dr.Heshmat hospital, Rasht.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
No Emergency Operation.
Patients with elective CABG.
Nonuse of the intra-aortic balloon pump.
The patient's ability to perform the exercise.
Nonexistence of valvular heart disease and chronic obstructive pulmonary disease.
Nonexistence of acute respiratory problems.
Nonexistence of Af.
Exclusion criteria :
Unstable angina.
Dysrhythmia.
Patient intolerancy CPAP.
Intervention groups
The first group: patients receive incentive spirometry like routine rehabilitation(control) and the second group: receive CPAP with mask 4-6 cmH2o until 35 minutes (case) besides routine.
Main outcome variables
Dyspnea
Spo2
Leg effort
Spirometry parameters:
General information
Reason for update
Acronym
GUMS
IRCT registration information
IRCT registration number:IRCT20101019004971N5
Registration date:2018-07-22, 1397/04/31
Registration timing:registered_while_recruiting
Last update:2018-07-22, 1397/04/31
Update count:0
Registration date
2018-07-22, 1397/04/31
Registrant information
Name
Mohamadtaghi Moghadabnia
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1555 2088
Email address
moghadamnia@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-05, 1397/03/15
Expected recruitment end date
2018-12-06, 1397/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey efficiency of the cardiac rehabilitation program after coronary artery bypass graft on respiratory characteristics.
Public title
Survey efficiency of cardiac rehabilitation program after coronary artery bypass graft on respiratory characteristics
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
No Emergency Operation
No CABG history in the past
clinical diagnosis of coronary artery disease, who underwent elective coronary Artery bypass graft (CABG) with cardiopulmonary bypass, a median sternotomy incision and use of a saphenous vein, internal thoracic artery, or radial artery grafts
No use of intra-aortic balloon pump
No use of permanent pacemaker
Ability to perform exercise according to our protocol
No valvular heart disease,chronic obstructive pulmonary disease
No respiratory problems that cause to add length of intensive care unit stay
No Atrial fibrilation arrhythmia and use of Amiodarone protocle
Exclusion criteria:
Unstable angina
chronic disturbances in heart rhythm
significant acute arrhythmias
Do not tolerate Continuous Positive Airway Pressure (CPAP) with patient
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
54
More than 1 sample in each individual
Number of samples in each individual:
1
Every participant stand in case or control group by randomization
Randomization (investigator's opinion)
Randomized
Randomization description
randomized a block size of 2
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
samples dispart into two groups (control and case) : first group receive incentive spirometry like routine rehabilitation and second group receive CPAP with mask 4-6 cmH2o until 35 minute (the first 5 minute allocate to reduce stress and adaptation with this device ) beside incentive spirometry . after 2 hours , progressive exercises as walking start in the first day, 5-10 minutes (base on patients tolerance ) , in the second day 10-15 minutes and in the third day 15 minutes and more . at the end of each cession all of the patients will evaluate with modified Borg scale CR-10 for dyspnea and RPE scale for leg effort . In the forth day the final results will evaluate with spirometery parameters .
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Deputy of Research and Technology of Guilan University of Medical Sciences ., across 17 shahahrivar hospital., shahid Siadati Ave., Namju Blvd., Rasht
City
Rasht
Province
Guilan
Postal code
4144665385
Approval date
2018-04-11, 1397/01/22
Ethics committee reference number
IR.GUMS.REC.1397.007
Health conditions studied
1
Description of health condition studied
efficiency of cardiac rehabilitation program after coronary artery bypass graft on respiratory characteristics
ICD-10 code
I25
ICD-10 code description
Chronic ischemic heart disease
Primary outcomes
1
Description
Dyspnea in patients who reveived score above 5 in Modified Category Ratio-10 (CR-10)
Timepoint
At the end of the first to third sessions after intervention
Method of measurement
Scoring in Modified Category Ratio-10 (CR-10)
2
Description
Leg effort in patients who reveived score above 15 in Rate of Perceived Exertion (RPE- Scale).
Timepoint
At the end of the first to third sessions after intervention
Method of measurement
Scoring in Rate of Perceived Exertion (RPE- Scale)
Secondary outcomes
1
Description
Spirometery parameters changes
Timepoint
In the forth session
Method of measurement
Spirometery
Intervention groups
1
Description
Intervention group: In this group patients besides receiving routine incentive spirometery in their cardiac rehabilitation program use Continuous Positive Airway Pressure mask(CPAP) till 35 minutes, due to patients tolerance before walking (the first 5 minutes related to reduce stress and adaptation) . In the first day, exercises start as walking (due to patients tolerance) 5-10 minutes , in the second day 10-15 ,and in the third day 15 minutes and more after 2 hours pass from using CPAP.
Category
Rehabilitation
2
Description
Control group: In this group patients receive incentive spirometery and deep breathing exercises for 30 minutes and then exercises start as walking (due to patients tolerance) 5-10 minutes , in the second day 10-15 ,and in the third day 15 minutes and more after 2 hours pass from using incentive spirometery .
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr.Heshmat hospital
Full name of responsible person
Mohammad Taghi Moghadamnia
Street address
Bayani alley., Mosala Blvd., Dr.Heshmat hospital
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3366 9064
Fax
+98 13 3366 8718
Email
moghadamnia@gums.ac.ir
Web page address
http://www.gums.ac.ir/heshmat
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Taghi Moghadamnia
Street address
GUMS central office building., Parastar Ave., namju Blvd
City
Rasht
Province
Guilan
Postal code
4193833697
Phone
+98 13 3355 5056
Email
moghadamnia@gums.ac.ir
Web page address
http://gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Taghi Moghadamnia
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No, 1, Havashenasi Ave, Moalem Blvd, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
4153754987
Phone
+98 31 3326 0090
Email
moghadamnia@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Taghi Moghadamnia
Position
َAssistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health in Emergency and Disaster
Street address
No. 1 Havashenasi Ave., Moalem Blvd.,Rasht., Iran
City
Rasht
Province
Guilan
Postal code
4153754987
Phone
+98 13 3326 0090
Email
Moghadamnia@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Taghi Moghadamnia
Position
َAssistant Professor of Rasht university of medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health in Emergency and Disaster
Street address
Nursing and Midwifery school., Daneshjo Ave., Shahiid Beheshti Blvd., Rasht
City
Rasht
Province
Guilan
Postal code
41534754987
Phone
+98 13 3326 0090
Email
Moghadamnia@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
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
Only a portion of the dataabout the outcome of interventions. will be shared.
Personal information will not be absolutely shared.
When the data will become available and for how long
The Six Months after publish of results
To whom data/document is available
University Researchers
Under which criteria data/document could be used
With formal request and Announcing the source of the data and Permission from researchers use of is allowed.
From where data/document is obtainable
Email to the moderator of the project, Mohammad Taghi Moghaddam Nia
Moghadamnia@gums.ac.ir
What processes are involved for a request to access data/document
After contacting to the email of moderator of project,the request will be reviwe and answered within 3 business days.