Protocol summary

Study aim
Investigating new HIIT training methods on reverse cholesterol transfer in CABG patients
Design
In this study, patients who are referred to the rehabilitation center of Farshchian Heart Hospital in Hamedan two months after the CABG operation with the recommendation letter of the surgeon and specialist doctor are selected for the second phase of rehabilitation. 30 people are selected and randomly divided into three continuous, 20-second and 60-second intermittent groups. Among the people who do not participate in the exercises, 10 people are randomly selected
Settings and conduct
This study is carried out in the rehabilitation department of Farshchian Heart Hospital in Hamedan under the supervision of a rehabilitation doctor, sports physiologist, physiotherapist, nurse and psychologist. Except the researcher, no one knows about the possible effect of training methods.
Participants/Inclusion and exclusion criteria
Coronary artery bypass surgery patients with an injection fraction higher than 30% and also an initial methadone higher than 5 were the conditions to enter this study.
Intervention groups
1. Control group 2. moderate-intensity continuous training (MIT) 3. high-intensity interval training 20sec (HIIT20sec) 4. high-intensity interval training 60sec(HIIT60sec)
Main outcome variables
The main variables of this study include: ABCA1, ABCG1, apoA, apoB, HDL, which are involved in the reverse transport of castrol.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230529058327N1
Registration date: 2023-08-03, 1402/05/12
Registration timing: retrospective

Last update: 2023-08-03, 1402/05/12
Update count: 0
Registration date
2023-08-03, 1402/05/12
Registrant information
Name
AliReza Ahmadvand
Name of organization / entity
The University of Bu Ali Sina
Country
Iran (Islamic Republic of)
Phone
+98 81 3825 4825
Email address
alireza.led@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
2022-04-21, 1401/02/01
Actual recruitment end date
2022-06-22, 1401/04/01
Trial completion date
2022-08-23, 1401/06/01
Scientific title
Effect of two high intensity interval training and one moderate continuous training methods on apo B/apo A ratio and ABCA1, ABCG1 expression in CABG patients.
Public title
Effect of two high intensity interval training and one moderate continuous training methods on apo B/apo A ratio and ABCA1, ABCG1 expression in CABG patients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Coronary artery bypass grafting patient male At least two months have passed since their surgery.
Exclusion criteria:
Met less than 5 Injection fraction less than 30 blood pressure Arthritis
Age
From 45 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization The names of 40 CABG patients who referred to the heart hospital for the second stage of rehabilitation after the operation were written on paper and each person was randomly assigned to one of the four control groups, MIT, HIIT20 and HIIT60.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient was explained the exercise program, the duration of the exercise, and how to do the activity. Also, the rehabilitation doctor, physiotherapist, nurse and psychologist were aware of the type and method of exercise, but they did not know what exercise method could have a specific effect.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Bu Ali Sina University
Street address
Mahdieh
City
Hamedan
Province
Hamadan
Postal code
۳۸۶۹۵-۶۵۱۷۸
Approval date
2021-02-28, 1399/12/10
Ethics committee reference number
IR.BASU.REC.1400.004

Health conditions studied

1

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

Primary outcomes

1

Description
ATP-binding cassette transporter A1 (ABCA1)
Timepoint
before the start of the first training session and 48 hours after the last training session (Week 8)
Method of measurement
Blood sampling from patients

2

Description
ATP-binding cassette transporter B1 (ABCG1)
Timepoint
before the start of the first training session and 48 hours after the last training session (Week 8)
Method of measurement
Blood sampling from patients

3

Description
Apolipoprotein A-1 (apoA-1)
Timepoint
before the start of the first training session and 48 hours after the last training session (Week 8)
Method of measurement
Blood sampling from patients

4

Description
high-density lipoprotein (HDL)
Timepoint
before the start of the first training session and 48 hours after the last training session (Week 8)
Method of measurement
Blood sampling from patients

5

Description
Apolipoprotein B (apoB-1)
Timepoint
before the start of the first training session and 48 hours after the last training session (Week 8)
Method of measurement
Blood sampling from patients

Secondary outcomes

empty

Intervention groups

1

Description
Control group: They did not receive any special training.
Category
Rehabilitation

2

Description
Intervention group 1: moderate-intensity continuous training (MIT). They received continuous aerobic exercises of 60%-80% maximum aerobic powe for three sessions a week with three devices: 1. Treadmill 2. Hand ergometer 3. Foot ergometer.
Category
Rehabilitation

3

Description
Intervention group 2: high-intensity interval training (HIIT20 sec).
Category
Rehabilitation

4

Description
Intervention group 3: high-intensity interval training (HIIT60 sec)
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Farshchian Heart Hospital
Full name of responsible person
Lobat Majidi
Street address
Ghaem Square
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۹۱۳۱
Phone
+98 81 3838 1741
Fax
+98 81 3838 1686
Email
alireza.led@gmail.com
Web page address
https://scanteb.com/listing/%D8%A8%DB%8C%D9%85%D8%A7%D8%B1%D8%B3%D8%AA%D8%A7%D9%86-%D9%81%D8%B1%D8%B4%DA%86%DB%8C%D8%A7%D9%86-%D9%87%D9%85%D8%AF%D8%A7%D9%86/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Ali Heidarianpour
Street address
Chaharbagh Ahmadi Roshan
City
Hamedan
Province
Hamadan
Postal code
65178-38695
Phone
+98 81 3838 1601
Email
alireza.led@gmail.com
Web page address
https://basu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bu Ali Sina University
Proportion provided by this source
30
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Bu Ali Sina
Full name of responsible person
AliReza Ahmadvand
Position
PHD Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Mahdieh Ave., Jafari Street.
City
Hamedan
Province
Hamadan
Postal code
6517733968
Phone
+98 81 3825 4825
Fax
Email
alireza.led@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Ali Heidarianpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Shariati Street, Pajohesh Square, Hamedan, Iran.
City
Hamedan
Province
Hamadan
Postal code
65178-38695
Phone
+98 81 3838 1422
Fax
+98 81 3838 1421
Email
Heidarian317@gmail.com
Web page address
https://basu.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Ali Heidarianpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Shariati Street, Pajohesh Square, Hamedan, Iran.
City
Hamedan
Province
Hamadan
Postal code
65178-38695
Phone
+98 81 3838 1422
Fax
+98 81 3838 1421
Email
Heidarian317@gmail.com
Web page address
https://basu.ac.ir/

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
Not applicable
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
TC,ABCA1, ABCG1,apoA,apoB, HDL, LDL,TG
When the data will become available and for how long
2023
To whom data/document is available
researchers
Under which criteria data/document could be used
The average data of the groups is available.
From where data/document is obtainable
Ali heidarianpour: Heidarian317@gmail.com Ali Reza Ahmadvand: Alireza.led@gmail.com
What processes are involved for a request to access data/document
About a month
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