Protocol summary

Study aim
The purpose of this study is to investigate the effects of eight weeks aerobic training and the usage of vitamins E and C on the plasma levels of matrix metalloproteinases (MMPS) 3, 2, 1 and 9 as well as their tissue inhibitor 1 (TIM1)) in patients with coronary artery disease(CAD).
Design
This experimental study is conducted on four groups, including three experimental groups with parallel interventions and a control group. 60 subjects are selected non-randomly and available mode and randomly assigned in these four groups.
Settings and conduct
This study is carried out in the field of improving the quality of health during the recovery period. supplements in cardiovascular patients. The research design is pre-test, post-test with the implementation of independent variables, which will be implemented in the Cardiac Rehabilitation Center of Bahman Hospital in Zanjan.
Participants/Inclusion and exclusion criteria
Patients with coronary artery disease (CAD) who their diagnosis of CAD (with the condition of at least 50% narrowing of at least two main coronary arteries) by cardiologists to be confirmed.
Intervention groups
The first group: They will perform aerobic training for eight weeks. The second group: they will take E and C supplements for eight weeks. The third group: Eight weeks of aerobic training will be performed along with taking supplements of vitamins E and C. The control group, during the eight-week experimental period, will only take the drugs prescribed by the physician and will not use any intervention of antioxidant drugs and exercise training
Main outcome variables
Investigating the effectiveness of long-term aerobic training on coronary artery remodeling indicators. Investigating the effectiveness of supplementing with antioxidant vitamins on coronary artery remodeling indicators.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240418061518N1
Registration date: 2024-05-25, 1403/03/05
Registration timing: registered_while_recruiting

Last update: 2024-05-25, 1403/03/05
Update count: 0
Registration date
2024-05-25, 1403/03/05
Registrant information
Name
Mahdi Reza ghlizadeh
Name of organization / entity
Islamic Azad university- zanjan branch
Country
Iran (Islamic Republic of)
Phone
+98 24 3345 5969
Email address
mahdi.reza@iau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-06-20, 1403/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of eight weeks aerobic training and vitamin E & C prescription on plasma levels of MMPS and their tissue inhibitor(TIM1) in patients with CAD
Public title
The effect of endurance training and consumption of antioxidant vitamins on disease progression in patients with CVD
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects have coronary artery disease (with the condition of at least 50% narrowing of at least two main coronary arteries), which has been confirmed by cardiologists based on examinations, complete blood tests, echocardiography, exercise stress test and angiography.
Exclusion criteria:
using of drugs or other antioxidant supplements other than the supplements considered in this research
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects will be selected with non-probability sampling method (Convenience sampling) and will be randomly assigned to four groups based on the functional capacity obtained from the initial exercise stress test.
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 islamic azad university. zanjan branvh
Street address
Daneshjoo Blvd., Paiin Kouh Road, Islamic Azad University of Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515658145
Approval date
2024-04-17, 1403/01/29
Ethics committee reference number
IR.IAU.Z.REC.1403.005

Health conditions studied

1

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

Primary outcomes

1

Description
Matrix Metalloproteinases 1، 2، 3 and 9
Timepoint
beginning and end of the eight-week experimental period
Method of measurement
Sampling of venous blood

2

Description
tissue inhibitor of Matrix Metalloproteinases 1
Timepoint
beginning and end of the eight-week experimental period
Method of measurement
Sampling of venous blood

Secondary outcomes

1

Description
Heart rate of subjects during exercise training
Timepoint
At the beginning, during and at the end of each exercise training session
Method of measurement
Using the cardiac monitoring device with the subjects

2

Description
Systolic and diastolic blood pressure of subjects during exercise
Timepoint
At the beginning and at the end of each exercise training session
Method of measurement
Using an analog blood pressure monitor

Intervention groups

1

Description
Intervention group: First group: eight weeks of aerobic training, second group: eight weeks of vitamin E and C supplements(1000 mg of D-Alpha Tocopherol Tablets by Life Plan Company per day and 1000 mg of Vitamin C Borrow made by Omid Persian Damavand Company per day), third group: eight weeks of aerobic training along with vitamin E and C supplements(1000 mg of D-Alpha Tocopherol Tablets by Life Plan Company per day and 1000 mg of Vitamin C Borrow made by Omid Persian Damavand Company per day).
Category
Rehabilitation

2

Description
Control group: During eight weeks, they will not experience any intervention of antioxidant drugs and training.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Bahman hospital
Full name of responsible person
Mahdi Rezagholizadeh
Street address
Behind Rozbeh University, Poonak town, 22 Bahman Highway
City
Zanjan
Province
Zanjan
Postal code
4515653346
Phone
+98 24 3303 9999
Fax
+98 24 3303 9237
Email
info@zbh.ir
Web page address
https://zbh.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Rasht Branch
Full name of responsible person
Ramin Shabani
Street address
Lacan Gate, Islamic Azad University, Rasht Branch
City
Rasht
Province
Guilan
Postal code
Phone
+98 13 3342 3308
Fax
+98 13 3344 7060
Email
iaurasht.ac@gmail.com
Web page address
https://rasht.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Rasht Branch
Proportion provided by this source
10
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
Islamic Azad University, Zanjan Branch
Full name of responsible person
Mahdi Rezagholizadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
۰Unit 10, Block 640, 5thwest street, Karmandan town
City
Zanjan
Province
Zanjan
Postal code
4513984363
Phone
+98 24 3345 5969
Email
mahdi.reza@iau.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University Zanjan Branch
Full name of responsible person
Mahdi Rezagholizadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Unit 10, Block 640, 5th west street,Karmandan town
City
zanjan
Province
Zanjan
Postal code
4513984363
Phone
+98 24 3345 5969
Email
mahdi.reza@iau.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University Zanjan Branch
Full name of responsible person
Mahdi Rezagholizadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Unit 10, Block 640, 5thwest street, Karmandan town
City
Zanjan
Province
Zanjan
Postal code
4513984363
Phone
+98 24 3345 5969
Email
mahdi.reza@iau.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
consult with other project colleagues
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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