Protocol summary

Summary
The present study investigated the effect of resistance exercise on lipid profil in coronary artery disease patients.inclusion criteria included coronary arteries’ involvement diagnosed by angiography ; two months after myocardial infarction (MI);10 days after coronary artery angioplasty; three months after coronary by- pass surgery. Exclusion criteria were playing an athletic sport; being absent for more than three sequential sessions in the rehabilitation program; incidence of severe health problems. amongst patients referred to cardiac rehabilitation unit of Isfahan Cardiovascular Research Center, forty eligible patients selected and assigned randomly to either intervention or control groups .The intervention period last 8 weeks included two exercise sessions 45 -60 min per week.In the intervention group, in addition to aerobic exercise, resistance exercise was performed. Study subjects in the control group participated only in aerobic exercise.Blood Fasting sample was taken for measurement of lipid profile at before, after and 4 weeks after the end of the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014121012551N2
Registration date: 2015-01-02, 1393/10/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-02, 1393/10/12
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
Isfahan University of Medical Sciences
Expected recruitment start date
2013-04-08, 1392/01/19
Expected recruitment end date
2014-02-18, 1392/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of resistance exercise on lipid profile in coronary artery disease patients:a clinical randomized trial
Public title
The effect of resistance exercise on lipid profile
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria : Having coronary arteries’ involvement diagnosed by angiography ; two months after myocardial infarction (MI);10 days after coronary artery angioplasty; three months after coronary by- pass surgery. Exclusion criteria : Playing an athletic sport; being absent for more than three sequential sessions in the rehabilitation program; incidence of severe health problems
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenuse, Isfahan
City
Isfahan
Postal code
Approval date
2013-03-02, 1391/12/12
Ethics committee reference number
392058

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
Lipid Profile
Timepoint
Before, After and 4 weeks after the end of the intervention
Method of measurement
Mg. Laboratory test

Secondary outcomes

1

Description
Blood Sugar
Timepoint
Before, After and 4 weeks after the end of the intervention
Method of measurement
Mg,Laboratory test

Intervention groups

1

Description
Intervention was conducted in the form of 45-–60 minute sessions, twice a week[12] (8-–12 AM) for eight 8 weeks in the rehabilitation unit of the cardiovascular research center.In the study group, in addition to aerobic exercises, resistance exercise was also administrated performed. In the first session, to determine the weight, the target weight was determined based on the heaviest weight each subject could lift for 12-–15 times in the expected range of motion. In all sessions, there were warm warm-up, exercise, and cool cool-down stages. Warm Warm-up and cool cool-down stages were conducted by with stretching exercises for 10-–15 min. The exercise included resistance exercise that was administrated performed for 20-–25 min, in addition to aerobic exercise. Resistance exercise was administrated performed by use of light weights in the range of motion of the elbow, shoulder, and knee joints. The number of repetitions in the range of motion was initially considered 10, and then, was gradually increased to 15. After the end of each set with 15 repetitions, the weight was increased by 3-–5% . In the second session, each subject held his/ her target weight in hand and administrated performed one set of side lateral, front, and overhead raise, overhead triceps extensions, alternating biceps curls and shoulder press, and weight squad with 10 repetitions. In the sessions 3-–7, a set of the above – -mentioned exercises were was repeated for 11 - 15 repetitions, respectively. In the 8th session, both the number of the sets and the weight were increased (by 3-–5% of the previous weight) in such a way that two sets of the above – -mentioned exercises were administrated performed by with 10 repetitions, with a rest period of one min between the sets. In sessions 9-–13, two sets of the above resistance exercises were administrated performed with 11 and 15 repetitions in each session, respectively, and a one minute rest period between the sets. In session 14, the number of the sets and the weight were increased again, . and in sessions 15-–16, three sets with repetitions of 11-–12 times were administrate dperformed.
Category
Rehabilitation

2

Description
Control group was conducted in the form of 45-–60 minute sessions, twice a week (8-–12 AM) for eight 8 weeks in the rehabilitation unit of the cardiovascular research center. Subjects in the control group just attended in a routine exercise session of in the rehabilitation unit in of the cardiovascular research center, which included running or treadmill with an average speed of 4four km/hr and cycling on a stationary bicycle for 15 min
Category
Rehabilitation

Recruitment centers

1

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

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Peyman Adibi
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenuse , Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
MS Student
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenuse, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2935
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
MS Student
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenuse, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2935
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
Full name of responsible person
Zahra Salehi
Position
MS Student
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences. Hezar Jerib Avenuse. Isfahan
City
Isfahan
Postal code
Phone
00
Fax
Email
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
Loading...