Protocol summary

Study aim
Investigating the effect of different respiratory rehabilitation protocols on cardiac recovery and hemodynamic parameters before and after coronary artery bypass graft surgery (CABG).
Design
Clinical trial with control group, unblinded, randomized, with parallel groups, on 75 patients. A table of random numbers was used for randomization.
Settings and conduct
This study is carried out as a clinical trial on 75 patients who are candidates for coronary artery bypass surgery, referring to Masih Deneshvari Hospital in Tehran, Iran. Patients who meet the study entry criteria will be placed in one of the study groups after providing full explanations and signing a written consent form.
Participants/Inclusion and exclusion criteria
Inclusion criteria include all patients who are candidates for coronary artery bypass surgery, exclusion criteria include age over 70 years, left main coronary artery (LMCA) lesion, history of MI, chest pain during exercise, and ECG changes during exercise.
Intervention groups
The first group includes patients who do not receive respiratory rehabilitation exercises before and after surgery (control group). The second group includes patients who perform respiratory rehabilitation exercises only after surgery. The third group includes patients who perform respiratory rehabilitation exercises before and after surgery.
Main outcome variables
Cardiac output, end-diastolic volume, end-systolic volume, left ventricular dimensions at the end of diastole, left ventricular dimensions at the end of systole, left ventricular extensor index, 6-minute walking test distance, resting heart rate, oxygen saturation at rest, maximum heart rat, VO2 max, fatigue level during activity, dyspnea

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230417057933N1
Registration date: 2023-04-27, 1402/02/07
Registration timing: prospective

Last update: 2023-04-27, 1402/02/07
Update count: 0
Registration date
2023-04-27, 1402/02/07
Registrant information
Name
Zargham_Hossein Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2002
Email address
zarghamahmadi@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of different respiratory rehabilitation protocols on cardiac recovery and hemodynamic parameters before and after coronary artery bypass graft surgery (CABG).
Public title
The effect of different respiratory rehabilitation protocols in patients undergoing coronary artery bypass graft surgery (CABG).
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All Coronary artery patients candidate for Coronary Artery Bypass Graft (CABG) surgery
Exclusion criteria:
Age
To 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method, individual randomization unit and random number table randomization tool. For randomization, we use a table consisting of random digits from 0 to 9. Each of the figures in this table is repeated the same on average. In this method, each figure is assigned to a treatment group. We start from the first row of the table and move down row by row. For three groups, we put numbers 1 to 3 for the first group, numbers 4 to 6 for the second group, and numbers 7 to 9 for the third group. We continue the above process until three groups are completed.
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
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Abbas Arabi St., Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2023-04-07, 1402/01/18
Ethics committee reference number
IR.SBMU.NRITLD.REC.1402.002

Health conditions studied

1

Description of health condition studied
Coronary artery bypass surgery
ICD-10 code
I25.709
ICD-10 code description
Atherosclerosis of coronary artery bypass graft(s), unspecified, with unspecified angina pectoris

Primary outcomes

1

Description
Cardiac output
Timepoint
At the beginning of hospitalization, 2 weeks after rehabilitation, after surgery, 2 weeks after surgery
Method of measurement
Eco cardiography

2

Description
End-diastolic volume
Timepoint
At the beginning of hospitalization, 2 weeks after rehabilitation, after surgery, 2 weeks after surgery
Method of measurement
Eco cardiography

3

Description
Resting heart rate
Timepoint
At the beginning of hospitalization, 2 weeks after rehabilitation, after surgery, 2 weeks after surgery
Method of measurement
Cardiopulmonary exercise test

4

Description
VO2 max
Timepoint
At the beginning of hospitalization, 2 weeks after rehabilitation, after surgery, 2 weeks after surgery
Method of measurement
Cardiopulmonary exercise test

5

Description
Fatigue during activity
Timepoint
At the beginning of hospitalization, 2 weeks after rehabilitation, after surgery, 2 weeks after surgery
Method of measurement
Borg scale

6

Description
Dyspnea
Timepoint
At the beginning of hospitalization, 2 weeks after rehabilitation, after surgery, 2 weeks after surgery
Method of measurement
Dyspnea index

Secondary outcomes

empty

Intervention groups

1

Description
Control group: In this group, patients do not receive respiratory rehabilitation exercises before and after surgery.
Category
Other

2

Description
Intervention group: Patients in this group perform respiratory rehabilitation exercises only after surgery (moderate intensity interval training (MIIT)). The training of this group will include 5 minutes of warming up and 28 minutes of intermittent activity (4 minutes of activity with an intensity of 70% of maximum oxygen consumption and 3 minutes of activity with 30% of maximum oxygen consumption) and 5 minutes of cooling down.
Category
Rehabilitation

3

Description
Intervention group: In this group of patients, before and after surgery, they perform respiratory rehabilitation exercises (high intensity interval training (HIIT). The training of this group includes 5 minutes of warm-up and 28 minutes of intermittent activity (4 minutes of activity with an intensity of 85% maximum oxygen). consumption and 3 minutes of activity with 30% of maximum oxygen consumption) and 5 minutes of cooling.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Zargham Hosein Ahmadi
Street address
Masih Daneshvari Hospital, Daarabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2612 5050
Email
zarghamahmadi@hotmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Abbas Arabi St., Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2243 9781
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohsen Abedi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Masih Daneshvari Hospital, Daarabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2612 5050
Email
mohsenabedi110@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zargham Hosein Ahmadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiac surgery
Street address
Masih Daneshvari Hospital, Daarabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2612 5050
Email
zarghamahmadi@hotmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reyhaneh Zahiri
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Biotechnology
Street address
Masih Daneshvari Hospital, Daarabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 2020
Email
zahirireyhane@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
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