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The comparison of the effect of two cardiac rehabilitation protocols (functional and ordinary) on atherosclerosis biomarkers and functional capacity in coronary arteries patients

Protocol summary

Study aim
The effect of 8 weeks of cardio functional training by ordinary cardiac rehabilitation protocol on cardiac injuries biomarker serum and functional indices in coronary artery patients.
Design
The current research is a semi-experimental type, which is conducted with two experimental groups in the form of a pre-and post-test. The population of the current study consists of patients with coronary artery disease. G.power software was used to select the statistical sample size with test power (1_β=0.95) and significance level (α=0.05) participating in the present study. Then the selected people are randomly divided into two control and rehabilitation exercise groups (functional and normal groups).
Settings and conduct
After meeting the entry criteria, the patients will be selected under the supervision of a specialist doctor at the Cardiovascular Research Institute of Isfahan University of Medical Sciences. After completing the consent form the selected people, their height, weight, and body composition will be measured. Then, functional tests including a 6MWT, TUG, Gait speed, blood pressure, and resting heart rate are performed. After taking the initial blood sample while fasting on the next day, the subjects are randomly assigned to two groups of functional training and normal training for 8 weeks, 3 sessions per week and each session is 45 minutes, and 72 hours after the last session Practice tests taken in the pre-test will be taken from them again.
Participants/Inclusion and exclusion criteria
Coronary artery patients who have a history of surgery use Beta blockers have a history of smoking, dyslipidemia, and hypertension, patients who are over 50 years old, participate in cardiac rehabilitation centers, have no use of alcohol, and do not have a history of regular exercise training.
Intervention groups
Ordinary and functional group
Main outcome variables
Apo-b, MPO, TUG, Gait speed, 6MWT.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231111060023N1
Registration date: 2023-11-30, 1402/09/09
Registration timing: registered_while_recruiting

Last update: 2023-11-30, 1402/09/09
Update count: 0
Registration date
2023-11-30, 1402/09/09
Registrant information
Name
Arezoo Soleymani fard
Name of organization / entity
Allameh Tabataba'i University
Country
Iran (Islamic Republic of)
Phone
+98 31 3447 8046
Email address
arezoo_soleymanifard@atu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of two cardiac rehabilitation protocols (functional and ordinary) on atherosclerosis biomarkers and functional capacity in coronary arteries patients
Public title
The comparison of cardiac rehabilitation protocols (functional and ordinary) on atherosclerosis biomarkers and functional capacity in coronary arteries patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Coronary artery patients who have surgery, usage of Beta blockers, patients who are over 50 years old, have hypertension, smoking, dyslipidemia, do not have a history of regular exercise, and participate in cardiac rehabilitation programs.
Exclusion criteria:
Usage of Alcohol. Disabled to do exercise, having a history of regular exercise training.
Age
From 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Research Ethics Committees of Allameh Tabataba'i University (ATU)
Street address
13th floor, Block A, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Simai Iran St., between South Flamak and Zarafshan, Quds Town (West), Tehran
City
Tehran
Province
Tehran
Postal code
1489684511
Approval date
2023-06-01, 1402/03/11
Ethics committee reference number
IR.ATU.REC.1402.015

Health conditions studied

1

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

Primary outcomes

1

Description
Apo-B
Timepoint
24 hours before the intervention and 72 hours after the intervention.
Method of measurement
In order to measure the amount of apoB, 10 cc of blood is taken first. Then 3-4 cc of it will be frozen and then placed in a centrifuge. The samples will be kept at a temperature of 20 degrees and then frozen at a temperature of 70 degrees Celsius. Finally, they will be measured using the biomarker kit from the isolated plasma.

2

Description
MPO
Timepoint
24 hours before the intervention and 72 hours after the intervention.
Method of measurement
In order to measure the amount of MPO, 10 cc of blood is taken first. Then 3-4 cc of it will be frozen and then placed in a centrifuge. The samples will be kept at a temperature of 20 degrees and then frozen at a temperature of 70 degrees Celsius. Finally, they will be measured using the biomarker kit from the isolated plasma.

Secondary outcomes

1

Description
6MWT
Timepoint
24 hours before the intervention and 72 hours after the intervention.
Method of measurement
It is a simple and inexpensive test, well tolerated by the patient. Also, a walking test for 6 minutes is an alternative to a cardiopulmonary exercise test (CPET) for risk classification in heart failure patients. The walking test should be performed for 6 minutes, preferably inside a closed space, on a flat surface in a corridor with a hard surface, and on a straight path that is usually at least 30 meters long. The patient is told to keep calm, take his medication, and wear comfortable clothes and shoes. The observer records baseline oxygen saturation, heart rate, brachial arterial blood pressure, and Borg scale ratings for dyspnea and fatigue. Now the patient understands the relevant instructions and then prepares to start the test. The walking path must be marked every 3 meters. It is also recommended to place cones at the turns of the paths. During the test, the participants are required to walk at a suitable speed according to their conditions, and they are allowed to do so if they wish to do so. Slow down in the road and stop. Then continue walking as soon as possible. The supervisor should always be ready to provide encouragement to the patient with appropriate phrases such as "You are doing well" and "Keep doing what you are doing". Encouragement has been shown to affect distance traveled, especially in the pediatric population. At the end of the test, the observer again records the Borg scale for shortness of breath and fatigue, and then selectively measures arterial blood pressure, heart rate, and oxygen saturation. The number of laps and additional distance covered by the registration and test is calculated by 6 minutes of walking.

2

Description
TUG
Timepoint
24 hours before the intervention and 72 hours after the intervention.
Method of measurement
The test of getting up and walking is the ability to perform consecutive movement tasks compared to walking and returning. This test is for a distance of 3 meters in a standard way, so that in the first stage, the initial rest is done, then the movement of getting up from the chair, then walking the path to the distance is three meters, turning the track, sitting on a chair and finally taking a final rest. Also, this test has been used to predict the risk of falling at the global level and has been widely accepted as a standard protocol for measuring the basic functional mobility of patients with Parkinson's disease. The normal time to complete this test is 8-12 seconds, which depends on age, and the observations obtained from the get-up-and-go test provide valuable medical information about strength (getting up from a chair), mobility (walking a short distance), and It provides balance (rotation) at the same time in an efficient manner

3

Description
Gait Speed
Timepoint
24 hours before the intervention and 72 hours after the intervention.
Method of measurement
First, the person walks in a normal state (walking with the aid that is allowed) in a straight line on a flat surface from a starting point to a standing position at a distance of 9 meters. The first distance is 2/ 5 meters. There is no time for 2/5 meters (which is called the acceleration phase). The time taken to move to the next 4-meter track is recorded by a hand-held stopwatch, and then the patient has another 5.2-meter track to be in a stationary position (called the deceleration phase). The fastest two consecutive test phases are recorded. It is described in meters per second.

Intervention groups

1

Description
Functional group: Functional training group: In the functional training group, moderate functional training (MIFT) will be used, which will include performing functional movements in a circle and using the rule of maximum number and possible rounds (AMRAP) in a period of 30 minutes. The movements will include six major movements, which are: squat, step-up, lunge, high knee jog, rotation with pivot, and Butt-kick jog. During the whole 30 minutes, the heart rate of the subjects will be controlled, and like aerobic training, the intensity of these exercises will be 60% to 80% of the training capacity, using the reserve heart rate, resting heart rate in a stationary or sitting position (HRrest). 20 to 30 beats.min-1} { or the level of perception of pressure 16-12 will be controlled on the scale of 6-20.
Category
Treatment - Devices

2

Description
Ordinary group: Subjects will train for 8 weeks, 3 sessions a week and each session will last 45 minutes. All sessions include a standard 10-minute warm-up that includes stretching (eg, upper neck mobility, shoulders, thoracic spine, hips, and ankle mobility) and an activity. Cardiovascular and neuromuscular briefs will be without resistance. Next, light static and dynamic stretching will be done. The aerobic training part of each session is rhythmic with large muscle group activities with an emphasis on increasing calorie consumption using a treadmill and bicycle. The duration of aerobic exercise will be 30 minutes and based on ACSM recommendations for people with cardiovascular disease characteristics participating in cardiac rehabilitation. The intensity of these exercises will be 60% to 80% of the training capacity, using the reserve heart rate, resting heart rate in a stationary or sitting position (HRrest)+20 to 30 beats.min-1} { or the pressure perception rate of 12-16 in the 6-20 scale will control. After completing the aerobic training part, the subjects will rest for 2 minutes. Finally, the training session will end with a 5-minute cooling down, including static and dynamic stretching movements, focusing on large joints.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan cardiovascular research institute
Full name of responsible person
Masoumeh Sadeghi
Street address
Isfahan cardiovascular research institute, Shahid Rahmani Alley,next to Shahid Chamran Heart Training Center, after Shahristan Bridge, 3rd Mushtaq St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81583-88994
Phone
+98 31 3611 5310
Fax
+98 31 3611 5303
Email
crc@mui.ac.ir
Web page address
https://icri.mui.ac.ir/fa/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Vice President of Research, Allameh Tabatabai University, Tehran
Street address
Tehran, Olympic Village, Dehkede Square, Central Campus of Allameh University Tabatabai
City
Tehran
Province
Tehran
Postal code
1489683991
Phone
+98 21 4839 2133
Fax
+98 21 4473 7562
Email
eslami.rasul@gmail.com
Web page address
https://atu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Allameh Tabataba'i University
Proportion provided by this source
15
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
Allameh Tabataba'i University
Full name of responsible person
Rasoul Eslami
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physilogy
Street address
Tehran, Olympic Village, Dehkede Square, Central Campus of Allameh University Tabatabai
City
Tehran
Province
Tehran
Postal code
1489684511
Phone
+98 21 4839 0000
Email
eslami.rasul@gmail.com
Web page address
https://atu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Arezoo Soleymani fard
Position
Master student
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
NO. 66, Arghavan impass, Shahid Hossein Sormeh alley, Tabib Isfahani avenue, Quds square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81498-67396
Phone
+98 31 3447 8046
Email
arezoo_soleymanifard@atu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Arezoo Soleymani fard
Position
Master student
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
NO.66, Arghavan impass, Shahid Hossein Sormen alley, Tabib Isfahani avenue, Quds square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81498-67396
Phone
+98 31 3447 8046
Email
arezoo_soleymanifard@atu.ac.ir

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
Due to the confidentiality of some patient information and their lack of consent to publish it.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
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