Effect of cardiac rehabilitation on level of endostatin, SDF1 and PDGF in patients with atherosclerosis after CABG
Design
The clinical task consisted of two groups of practice and control in a simple random method with factorial group
Settings and conduct
Exercises were performed in rehabilitation ward of Mashhad Javad Alaemeh Cardiovascular Specialist Hospital in two simple randomized, non-blinded, aerobic and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 40-60 years who underwent coronary artery bypass graft surgery and had no hypertension, diabetes, and chest pain.
Exclusion criteria: Patients with hypertension, diabetes, chest pain.
Intervention groups
Intervention group: Patients aged 40-60 years who underwent coronary artery bypass graft surgery and received resistance aerobic combined exercise intervention.
Control group: Patients aged 40-60 years who underwent coronary artery bypass graft surgery and did not receive resistance aerobic combined exercise intervention.
Main outcome variables
Plasma levels of endostatin, SDF1 and PDGF
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191228045916N1
Registration date:2020-02-04, 1398/11/15
Registration timing:retrospective
Last update:2020-02-04, 1398/11/15
Update count:0
Registration date
2020-02-04, 1398/11/15
Registrant information
Name
Hadi Seyedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 1763 0790
Email address
h.seyedi@iau-neyshabur.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-07, 1398/06/16
Expected recruitment end date
2019-10-12, 1398/07/20
Actual recruitment start date
2019-09-07, 1398/06/16
Actual recruitment end date
2019-10-12, 1398/07/20
Trial completion date
2019-10-12, 1398/07/20
Scientific title
Effect of cardiac rehabilitation on level of endostatin, SDF1 and PDGF in patients with atherosclerosis after CABG
Public title
Effect of cardiac rehabilitation on level of endostatin, SDF1 and PDGF in patients with atherosclerosis after CABG
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being a man
Aged 40 to 60 years
Performing a coronary artery bypass graft in the past two months
Exclusion criteria:
Chest pain
Hypertension disorder
Diabetes
Age
From 40 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
24
Randomization (investigator's opinion)
Randomized
Randomization description
The simple and easy design method is used with the design of the numeric table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Use of Aerobic-Resistance Combined Exercise Method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Neyshabur University
Street address
Khorasan Razavi Province, Neyshabur, Abbey Road
City
neyshabur
Province
Razavi Khorasan
Postal code
9319975853
Approval date
2019-09-05, 1398/06/14
Ethics committee reference number
IR.IAU.NEYSHABUR.REC.1398.018
Health conditions studied
1
Description of health condition studied
Patients aged 60-40 years who underwent coronary artery bypass graft surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
endostatin
Timepoint
Blood sampling in the pre-test phase 24 hours before the first training session and 48 hours after the last training session
Method of measurement
Blood sampling from brachial vein and testing by Real-Time-PCR
2
Description
SDF1
Timepoint
Blood sampling in the pre-test phase 24 hours before the first training session and 48 hours after the last training session
Method of measurement
Blood sampling from brachial vein and testing by Real-Time-PCR
3
Description
PDGF
Timepoint
Blood sampling in the pre-test phase 24 hours before the first training session and 48 hours after the last training session
Method of measurement
Blood sampling from brachial vein and testing by Real-Time-PCR
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients aged 40-60 years who underwent coronary artery bypass graft surgery and received aerobic-resistance combined exercise intervention.
Category
Rehabilitation
2
Description
Control group: Control group: Patients aged 40-60 years who underwent coronary artery bypass graft surgery and did not receive aerobic resistance training.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Javad Alameh Hospital
Full name of responsible person
Dr. Emad Alavi Nia
Street address
Vakilabad Boulevard, Conservatory Road
City
mashhad
Province
Razavi Khorasan
Postal code
9178613111
Phone
+98 51 6010 3881
Fax
+98 51 8103 3883
Email
info@jhosp.org
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
rambod khajee
Street address
Khorasan Razavi Province, Neyshabur, Abbey Road
City
neyshabur
Province
Razavi Khorasan
Postal code
9319975853
Phone
+98 51 4262 1901
Fax
Email
neyshabur@iau-neyshabur.ac.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
Proportion provided by this source
1
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
Full name of responsible person
seyed hadi seyedi
Position
coach
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Adel Khomeini Street, Adel Khomeini 67, No. 33
City
mashhad
Province
Razavi Khorasan
Postal code
9174884641
Phone
+98 51 3763 0790
Email
seyedi9@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
seyed hadi seyedi
Position
coach
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Adel Khomeini Street, Adel Khomeini 67, No. 33
City
mashhad
Province
Razavi Khorasan
Postal code
9174884641
Phone
+98 51 3763 0790
Email
seyedi9@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
seyed hadi seyedi
Position
coach
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Adel Khomeini Street, Adel Khomeini 67, No. 33
City
mashhad
Province
Razavi Khorasan
Postal code
9174884641
Phone
+98 51 3763 0790
Email
seyedi9@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
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only part of the data related to the original outcome is shared
When the data will become available and for how long
1 year after publishing the results
To whom data/document is available
Researchers working in academia and people in the industry
Under which criteria data/document could be used
Certain conditions are not considered
From where data/document is obtainable
Communication with the responsible person
What processes are involved for a request to access data/document