Protocol summary

Study aim
Comparison of the Effect of Eight Weeks Aerobic and Combined Exercise on Hemodynamic, Hemorheological, Structural and Functional indicators of the Heart in Middle-Aged Male Patients undergoing Coronary Artery Bypass Graft Surgery.
Design
The Cinical trial has Aerobic, Combination and Control groups, a blind strain, randomized on 30 patients. A simple lottery method was used for randomization.
Settings and conduct
Exercises will be performed in Imam Ali Hospital, Kermanshah, three sessions a week for eight weeks and each session will be 1 hour. Without knowing the study group, the subject is placed in a special group by lottery and random.
Participants/Inclusion and exclusion criteria
Middle-aged male patients undergoing coronary artery surgery Inclusion criteria: men, coronary artery surgery within the previous 8 weeks, heart contractility greater than 40%, surgery by a single surgeon and echocardiography by a single cardiologist, not smoking for at least three months. Exclusion criteria from the study: Musculoskeletal disease, sports activity outside of the study program, absence of more than two sessions in training sessions, moving from Kermanshah, disease and new symptoms during the study.
Intervention groups
Aerobic group training (1 hour) includes the use of Treadmills, Stationary bikes, Ergometer, warm-up and cool-down. Combined group exercises (1 hour) include: use of Treadmill, Stationary cycling, Ergometer cycle and Resistance training During the sessions, it will increase from 8 repetitions of three sets to 15 repetitions. Warm-up and cool-down. Control group patients do not undergo training. In the patients of all three groups, before and after the trial, Structural and Functional indices of the Heart, Hemodynamic and Hemorheological factors are examined.
Main outcome variables
Structural and Functional indices of the Heart, Hemodynamic and Hemorheological variables

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221031056349N1
Registration date: 2023-03-18, 1401/12/27
Registration timing: prospective

Last update: 2023-03-18, 1401/12/27
Update count: 0
Registration date
2023-03-18, 1401/12/27
Registrant information
Name
Peyman Kaikhosro Doulatyari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3836 0295
Email address
p.k.doulatyari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Eight Weeks Aerobic and Combined Exercise on Hemodynamic, Hemorheological, Structural and Functional indicators of the Heart in Middle-Aged Male Patients Undergoing Coronary Artery Bypass Graft
Public title
The Effect of Eight Weeks of Aerobic and Combined Exercises in Middle-Aged Male Patients Undergoing Coronary Artery Bypass Graft Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Men Have undergone Coronary Artery Surgery within the previous 8 Weeks The Heart's contractile strength should be above 40% Take the same Heart medication Surgery should be done by the same Surgeon and Echo by the same Cardiologist No smoking for at least three months
Exclusion criteria:
Musculoskeletal disease that hinders the Patient's activity Smoking Exercise activity in addition to the current study program Moved from Kermanshah Illness, Surgery or severe limiting pain Taking sports supplements or special drugs
Age
From 45 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The way to select the subjects is that people who are interested in participating in the trial are first invited. Then, the selection of the subjects is done in such a way that among the subjects, a researcher-made questionnaire containing information related to Name, Age, Height, Weight, History of sports activities, use of Sports supplements, Smoking, History of diseases and type of Drugs is prepared. And it is provided to the subjects for completion. After examining the answers of the subjects to the questions in the questionnaire, people who have a history of regular sports activity, participation in a weight training program, use of sports supplements, a history of pain, discomfort and surgery in the organs and musculoskeletal system, a history of smoking and limiting diseases If they do not have and meet the conditions to participate in the research, they will participate in the trial. At first, the subjects are visited and evaluated by a specialist doctor to ensure that they are not prohibited from participating in exercise groups. Then, 30 subjects between the ages of 45 and 65 are selected from among the qualified candidates. Each subject is assigned a number and randomly placed in a special group.
Blinding (investigator's opinion)
Single blinded
Blinding description
At first, it is explained to all the subjects that they are participating in a study, and after the explanation, a consent form is obtained. But the subjects do not know which study group they are in.
Placebo
Not used
Assignment
Factorial
Other design features
In this study, Structural and Functional indicators of the Heart and Hemodynamic and Hemorheological variables are investigated simultaneously.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University- Kermanshah Branch
Street address
End of Farhikhtegan Blvd, Ferdowsi Square
City
Kermanshah
Province
Kermanshah
Postal code
6718997551
Approval date
2023-03-07, 1401/12/16
Ethics committee reference number
IR.IAU.KSH.REC.1401.002

Health conditions studied

1

Description of health condition studied
Coronary artery occlusion
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery

Primary outcomes

1

Description
The size and amount ofStructural indicators of the Heart
Timepoint
Before starting the study and 8 weeks later
Method of measurement
Echocardiography device

2

Description
The level of functional indicators of the Heart
Timepoint
Before starting the study and 8 weeks later
Method of measurement
Echocardiography device

3

Description
The percentage of people with high Hemodynamic indices
Timepoint
Before starting the study and 8 weeks later
Method of measurement
Sphygmomanometer

4

Description
The percentage of people with high Hemorheological indices
Timepoint
Before starting the study and 8 weeks later
Method of measurement
laboratory equipment

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: First intervention group, Aerobic exercises.Three sessions per week for 8 weeks and each session is one hour. Before and after the trial, Echocardiography (Structural and Functional indices of the Heart), Hemodynamic and Hemorheological factors are checked.
Category
Rehabilitation

2

Description
Intervention group: The Second intervention group, Combined exercises group.Three sessions per week for 8 weeks and each session is one hour.Before and after the trial, Echocardiography (Structural and Functional indices of the Heart), Hemodynamic and Hemorheological factors are checked.
Category
Rehabilitation

3

Description
Control group: In this group, subjects do not exercise. Before and after the trial, Echocardiography (Structural and Functional indices of the Heart), Hemodynamic and Hemorheological factors are checked.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali(A) Cardio Vascular Research, Education and Treatment Center
Full name of responsible person
Sedigheh Hosseinpour Delavar
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847145
Phone
+98 83 3836 0295
Fax
+98 83 3836 0043
Email
p.k.doulatyari@gmail.com
Web page address
https://imamali.kums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Buchani
Street address
End of Farhikhtegan Blvd, Ferdowsi Square
City
Kermanshah
Province
Kermanshah
Postal code
6718997551
Phone
+98 83 3724 3181
Fax
Email
Info@iauksh.ac.ir
Web page address
https://kermanshah.iau.ir/
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University of Kermanshah
Proportion provided by this source
10
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
Kermanshah University of Medical Sciences
Full name of responsible person
Peyman Kaikhosro Doulatyari
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
Imam Ali Hospital, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847145
Phone
+98 83 3836 0295
Email
p.k.doulatyari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Peyman Kaikhosro Doulatyari
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Ali Hospital, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847145
Phone
+98 83 3836 0295
Email
p.k.doulatyari@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Peyman Kaikhosro Doulatyari
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847145
Phone
+98 83 3836 0295
Email
p.k.doulatyari@gmail.com

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
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Means and standard deviations of descriptive data and pre- and post-trial data can be shared after de-identifying subjects.
When the data will become available and for how long
After the publication of the article
To whom data/document is available
Researchers of scientific and academic institutions
Under which criteria data/document could be used
No new analysis is allowed. Researchers can refer to the results
From where data/document is obtainable
To access the general results, please send an email to p.k.doulatyari@gmail.com
What processes are involved for a request to access data/document
After the request to the e-mail, it will be answered within a week at most
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