The purpose of this study was to investigate the effects of 8 weeks of aerobic exercise on serum concentrations of Brain Natriuretic Peptide and C - reactive protein in patients with cardiovascular disease. Patients were divided randomly into two groups: control and experimental aerobic group. This study was done with two - stage blood sampling: at the beginning and at the end of the treatment phase. All subjects were requested to refrain any exercise at least 48 hours before blood sampling. To study Brain Natriuretic Peptide and C - reactive protein changes, 5 ml of blood was taken from patient’s brachial vein. Blood samples for subsequent measurement were frozen immediately and transported to the Hormone Laboratory for serum separation. The experimental group did the aerobic exercise programs for 8 weeks for 3 sessions per week and the control group did not receive any training. After completion of training, the final blood sampling was performed. Exercise intensity according to the heart rate remained stable in until last week. Brain Natriuretic Peptide and C - reactive protein levels were measured by ELISA test. All statistical analysis were done using SPSS software (version 16) and at the significance level of p≤ 0/05.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014011316209N1
Registration date:2015-05-20, 1394/02/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-20, 1394/02/30
Registrant information
Name
Mohammadali Ostovan
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 5609
Email address
ostovanm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science
Expected recruitment start date
2013-07-21, 1392/04/30
Expected recruitment end date
2014-07-20, 1393/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The influence of aerobic exercise on serum Brain Natriuretic Peptide and C- Reactive Protein in cardiovascular disease
Public title
Aerobic exercise in cardiovascular disease
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:In this trial patients with coronary artery disease more than 70 percent at least in one coronary vessel with Ejection Fraction more than 40 percent in recent Echo cardiograph without acute evidence of ischemia or congestive heart failure symptoms were selected and are divide randomly into two groups.
exclusion criteria:patients with acute evidence of ischemia or congestive heart failure symptoms are excluded.
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Science, Zand street, Shiraz, Fars, Iran
City
Shiraz
Postal code
71348-14336
Approval date
2014-01-04, 1392/10/14
Ethics committee reference number
CT-P-92-6517
Health conditions studied
1
Description of health condition studied
Cardiovascular
ICD-10 code
I51.6
ICD-10 code description
Disease, diseased - cardiovascular
Primary outcomes
1
Description
Brain Natriuretic Peptide
Timepoint
Before intervention and 2 months after intervention
Method of measurement
ELISA
2
Description
C- Reactive Protein
Timepoint
Before intervention and 2 months after intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
Heart rate
Timepoint
At the beginning and at the end of 8 weeks
Method of measurement
Electrocardiogram
2
Description
Blood pressure
Timepoint
At the beginning and at the end of 8 weeks
Method of measurement
Sphygmomanometer
Intervention groups
1
Description
Aerobic exercise
instruments: ergo meter bicycle
60-55% of their target heart rate
3 sessions per week
Category
Prevention
2
Description
In this group, no intervention is done.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital, Cardiac Rehabilitation Department
Full name of responsible person
Najmeh Sheykhiyan
Street address
Shiraz University of Medical Science, Zand street, Shiraz, Fars, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr.Ali Poostforoosh
Street address
Shiraz University of Medical Science, Zand street, Shiraz, Fars, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Najmeh Sheykhiyan
Position
M.A of Physical Education
Other areas of specialty/work
Street address
Shiraz University of Medical Science, Zand street, Shiraz, Fars, Iran