Protocol summary

Summary
The aim of present study is investigation the effect of resistance exercise on mean blood pressure in the cardiovascular patients. 40 eligible patients admitted to the rehabilitation unit of Cardiovascular Research center who had hypertension, Coronary artery disease or history of coronary artery bypass graft surgery assigned randomly to intervention and control groups. In every group, one day before the beginning of the intervention, Demographic data was collected. Blood pressure was measured and recorded. Blood sampling was taken for fasting blood sugar and lipid profile measurement. One day after the end of the intervention blood pressure , fasting blood sugar and lipid profile was controlled. During the study period of 8 weeks, all the study subjects participated two exercise sessions last 45-60 minutes, per week. The control group followed routine rehabilitation unit protocol that was aerobic exercise and in the intervention group, in addition to routine exercise, resistance exercise was performed too: at the first session of the intervention, the weight was determined. At the start, the numbers of repetitions in the range of motion were considered 10 repetitions that increased gradually to 15 repetitions. After the each set of 15 repetitions, the amount of weight( 3-5 percent) and number of sets raised

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013022112551N1
Registration date: 2014-01-15, 1392/10/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-01-15, 1392/10/25
Registrant information
Name
Zahra Salehi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 3081
Email address
z_salehi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahahan University of medical Sciences , Dr Peyman Adibi
Expected recruitment start date
2013-04-09, 1392/01/20
Expected recruitment end date
2014-01-10, 1392/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of resistance exercise on coronary artery disease risk factorsin the patients referred to Isfahan Cardiovascular Research center
Public title
effect of Exercise on coronary artery disease risk factors
Purpose
Supportive
Inclusion/Exclusion criteria
Iinclusion criteria: Patients referring to the Isfahan Cardiovascular Research center; being pre-hypertensive;stage1 hypertensive ; taking lowering blood pressure drugs; history of myocardial infarction prior 2 months, ten days after coronary angioplasty;3 months after heart bypass surgery Exclusion criteria: Smoking; professional in exercise; participation in an exercise program during the last 3 months; absence for more than three consecutive meetings rehabilitation program; the incidence of acute conditions associated with health; limitations to exercise
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
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
Isfahahan University of Medical Sciences
Street address
Isfahahan University of Medical Sciences,Hezar Jerib Avenue ,
City
Isfahahan
Postal code
Approval date
2013-04-30, 1392/02/10
Ethics committee reference number
392058

Health conditions studied

1

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

Primary outcomes

1

Description
Mean blood pressure
Timepoint
The bigining and the end of the intervention
Method of measurement
Mmhg- Sphygmomanometer

Secondary outcomes

1

Description
fasting blood sugar
Timepoint
The bigining and the end of the intervention
Method of measurement
Mg/ dl. Iaboratory measuerments

2

Description
lipid profile
Timepoint
The bigining and the end of the intervention
Method of measurement
Mg/ dl. Iaboratory measuerments

Intervention groups

1

Description
20 eligible subjects assigned randomly to intervention group. In the intervention group, one day before the beginning of the intervention, Demographic data was collected. Blood pressure was measured and recorded. Blood sampling was taken for fasting blood sugar and lipid profile measurement. One day after the end of the intervention blood pressure , fasting blood sugar and lipid profile was controlled. During the study period of 8 weeks, all the study subjects participated two exercise sessions last 45-60 minutes, per week. in the intervention group, in addition to routine exercise, resistance exercise was performed too: at the first session of the intervention, the weight was determined. At the start, the numbers of repetitions in the range of motion were considered 10 repetitions that increased gradually to 15 repetitions. After the each set of 15 repetitions, the amount of weight( 3-5 percent) and number of sets raised
Category
Rehabilitation

2

Description
20 eligible subjects assigned randomly to control group. In the control group, one day before the beginning of the intervention, Demographic data was collected. Blood pressure was measured and recorded. Blood sampling was taken for fasting blood sugar and lipid profile measurement. One day after the end of the intervention blood pressure , fasting blood sugar and lipid profile was controlled. During the study period of 8 weeks, all the study subjects participated two exercise sessions last 45-60 minutes, per week. The control group followed routine rehabilitation unit protocol that was aerobic exercise
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Cardiovascular Research Center
Full name of responsible person
Zahra Salehi
Street address
City
Isfahahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahahan University of Medical Sciences
Full name of responsible person
Vice chancellor for research,Dr Peyman Adibi
Street address
Isfahahan University of Medical Sciences,Hezar Jerib Avenue ,
City
Isfahahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Zahra Salehi
Position
msc student
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences,Hezar Jerib Ave
City
Isfahan
Postal code
Phone
+98 33 4243 2929
Fax
Email
z_salehi@nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Zahra Salehi
Position
msc student
Other areas of specialty/work
Street address
Isfahahan University of Medical Sciences,Hezar Jerib Avenue
City
Isfahahan
Postal code
Phone
+98 33 4243 2929
Fax
Email
z_salehi@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences, Isfahan, Iran
Full name of responsible person
Zahra Salehi
Position
msc student
Other areas of specialty/work
Street address
Isfahahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Postal code
Phone
+98 33 4243 2929
Fax
Email
z_salehi@nm.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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