Protocol summary

Study aim
This study was designed to evaluate the effect of one bout of continuous aerobic training versus intravenous exercise on plasma ICAM-1 and VCAM-1 levels in coronary artery disease patients.
Design
Nine women with coronary artery disease who had at least 3 regular exercise sessions per week for the past 6 months were selected. Following confirmation of the disease, they underwent cardiac rehabilitation exercise programs for clinical trials, exercise testing, and angiography.
Settings and conduct
After selecting the subjects, a full explanation of the goals, benefits of the exercise and completion of the written consent form, medical history and physical activity readiness questionnaire (PAR_Q) will be completed. In order to eliminate possible differences between the study groups, the study is cross-sectional and voluntary. This experimental design is carried out in the summer of 1998 at the laboratory of Payame Noor University.
Participants/Inclusion and exclusion criteria
women with coronary artery disease
Intervention groups
There is one group in the study and exercise interventions twice. The first stage consisted of running or walking for 30 minutes at 60% of the plateau heart rate intensity. The second phase also included intermittent activity consisting of 30 minutes of walking or running at a variable intensity between 50% (2 minutes) and 80% (1 minute) of the plateau heart rate.
Main outcome variables
ICAM-1 (Intercellular Adhesion Molecule 1)؛ VCAM-1 (Vascular cell adhesion molecule-1)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190831044649N1
Registration date: 2019-09-13, 1398/06/22
Registration timing: registered_while_recruiting

Last update: 2019-09-13, 1398/06/22
Update count: 0
Registration date
2019-09-13, 1398/06/22
Registrant information
Name
Ali Barzegari
Name of organization / entity
Payame noor university
Country
Iran (Islamic Republic of)
Phone
+98 11 3225 0048
Email address
ali_barzegari@pnu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-07, 1398/06/16
Expected recruitment end date
2019-09-14, 1398/06/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of One Bout of Continuous Aerobic Exercise against Interval on ICAM-1 and VCAM-1 Plasma Levels in Patients with Coronary Artery Disease
Public title
The Effect of One Bout of Continuous Aerobic Exercise against Interval on ICAM-1 and VCAM-1 Plasma Levels in Patients with Coronary Artery Disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Known coronary artery disease (based on medical records) Having over 60 years old Failure to exercise test History of angiography History of CCU admission No record of regular physical activity during the three months prior to the intervention
Exclusion criteria:
healthy people Patients with a history of using pacemaker stabilized blood failure Head injury history in the last six months Myocardial infarction history of other diseases
Age
From 61 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 9
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of payame noor university
Street address
Department of physical education and sport, Payame Noor University, PO BOX 19395-3697, Tehran, IRAN
City
تهران
Province
Alborz
Postal code
4697-19395
Approval date
2018-12-29, 1397/10/08
Ethics committee reference number
IR.PNU.REC.1397.069

Health conditions studied

1

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

Primary outcomes

1

Description
New indices ICAM-1 (Intercellular Adhesion Molecule 1)
Timepoint
Before and after the training protocols
Method of measurement
Enzyme-linked Immunosorbent Assay

2

Description
VCAM-1 (Vascular cell adhesion molecule-1)
Timepoint
Before and after the training protocols
Method of measurement
Enzyme-linked Immunosorbent Assay

Secondary outcomes

empty

Intervention groups

1

Description
After selecting the subjects, a full explanation of the goals, benefits of the exercise, and a written consent form, medical history and physical activity readiness questionnaire (PAR_Q) were completed. In order to eliminate the possible differences of the study group, the study was cross-sectional and voluntary. The first session of the program introduced the equipment and training methods. Subjects were asked to avoid physical activity and any physical stimuli (eg caffeine, tobacco, and alcohol) 48 hours prior to exercise. They were also asked not to eat for 2 hours before exercise (drinking water was allowed). The exercise test was performed according to the modified Bruce protocol and performed on a treadmill and electrocardiogram of COSMED 200 (COSMED), Italy. The test was stopped by observing one of the symptoms of abnormal electrocardiography, the Borg 17 pressure scale, and the plateau heart rate. After 72 hours, the subjects were randomly assigned to a single-week aerobic interval training protocol. Continuous activity was performed by running or walking for 30 minutes at 60% intensity of the plateau heart rate. Periodic activity also included 30 minutes of walking or running with varying intensities between 50% (2 minutes) and 80% (1 minute) of the plateau heart rate and with a mean workload of 60% of the reserve heart rate.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rajaie heart hospital
Full name of responsible person
Habibollah Rezayi
Street address
Next to Mellat Park, Shahid Rajaee Cardiovascular Training, Research and Therapeutic Center, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
Diplomat@rhc.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Payame noor university
Full name of responsible person
Hasan Alizadeh
Street address
Nakhl St, Lashkarak Highway, Tehran
City
Tehran
Province
Tehran
Postal code
4697-19395
Phone
+98 21 2332 0000
Email
ali_barzegari@pnu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Payame noor university
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
Payame noor university
Full name of responsible person
Ali Barzegari
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
Nakhl St, Lashkarak Highway, Tehran
City
Tehran
Province
Tehran
Postal code
469719395
Phone
+98 21 2332 0000
Email
ali_barzegari@pnu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Payame noor university
Full name of responsible person
Ali Barzegari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
Nakhl St, Lashkarak Highway, Tehran
City
Tehran
Province
Tehran
Postal code
4697-19395
Phone
+98 21 2332 0000
Email
ali_barzegari@pnu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Payame noor university
Full name of responsible person
Ali Barzegari
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
Nakhl St, Lashkarak Highway, Tehran
City
Tehran
Province
Tehran
Postal code
4697-19395
Phone
+98 21 2332 0000
Email
ali_barzegari@pnu.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
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
Title and more details about the data/document
The results of the study are provided to the samples.
When the data will become available and for how long
3 months after the article was published
To whom data/document is available
Subjects
Under which criteria data/document could be used
For further research
From where data/document is obtainable
Researcher -Payame noor university
What processes are involved for a request to access data/document
It takes about 2 weeks.
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