Protocol summary

Summary
The aim of this study is to evaluate the effect of 8 weeks cardiac rehabilitation on systolic, diastolic function, LV mass and functional capacity in patients with myocardial infarction. Twenty-nine post myocardial patient will be enrolled in experimental and control group. Systolic function and left ventricle mass measured by 2-dimentional echocardiography, diastolic function measured by pulsed wave doppler and functional capacity by symptom limited exercise test based on Naughton protocol on treadmill will be performed at baseline and after 8 weeks of training. The result will be compared in study groups.

General information

Acronym
Cardiac Rehabilitation
IRCT registration information
IRCT registration number: IRCT201011085136N1
Registration date: 2011-05-10, 1390/02/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-05-10, 1390/02/20
Registrant information
Name
Fatemeh Basati
Name of organization / entity
Mohaghagh Ardebili University
Country
Iran (Islamic Republic of)
Phone
+98 21 2298 9007
Email address
fatemeh.basati1987@gmail.com
Recruitment status
Recruitment complete
Funding source
Isfahan Cardiovascular Research Center
Expected recruitment start date
2010-11-06, 1389/08/15
Expected recruitment end date
2010-11-21, 1389/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a cardiac rehabilitation program on systolic, diastolic function, left ventricle mass and functional capacity in patient with myocardial infarction
Public title
Cardiac Rehabilitation in Heart Disease Patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with ST elevation myocardial infarction, history of CABG and PTCA, have ability to present in cardiac rehabilitation program, not having any physical exercise out of cardiac rehabilitation program, cardiac rehabilitation start 2 month after CABG and 1 month after PTCA Exclusion criteria: Absence more than five sessions in rehabilitation programs, re-infarction, extra physical activity.
Age
From 37 years old to 67 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
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
Cardiovascular Research Center ethics Committee
Street address
Cardiovascular Research Center, Khorram av., Jomhori Eslami Sq.,
City
Isfahan
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
1/89103

Health conditions studied

1

Description of health condition studied
Myocardial Infarction
ICD-10 code
I23
ICD-10 code description
Myocardial Infarction specified as Acute or with a stated duration of 4 weeks (28 days) or less from onset

Primary outcomes

1

Description
Left Ventricular End Diastolic Dimention
Timepoint
Before Intervention and 2 month After Intervention
Method of measurement
2 Dimentional Echocardiography

2

Description
Left Ventricular End Systolic Dimention
Timepoint
Before Intervention and 2 month After Intervention
Method of measurement
2 Dimentional Echocardiograph

3

Description
Left Ventricular End Systolic Volume
Timepoint
Before Intervention and 2 month After Intervention
Method of measurement
2 Dimentional Echocardiograph

4

Description
Left Ventricular End Diastolic Volume
Timepoint
Before Intervention and 2 month After Intervention
Method of measurement
2 Dimentional Echocardiograph

5

Description
Ejection Fraction
Timepoint
Before Intervention and 2 month After Intervention
Method of measurement
2 Dimentional Echocardiograph

6

Description
Stroke Volume
Timepoint
Before Intervention and 2 month After Intervention
Method of measurement
2 Dimentional Echocardiograph

7

Description
E velocity
Timepoint
Before Intervention and 2 month After Intervention
Method of measurement
Pulsed Wave Doppler Echocardiography

8

Description
A velocity
Timepoint
Before Intervention and 2 month After Intervention
Method of measurement
Pulsed Wave Doppler Echocardiography

9

Description
E/A ratio
Timepoint
Before Intervention and 2 month After Intervention
Method of measurement
Pulsed Wave Doppler Echocardiography

10

Description
Deceleration time
Timepoint
Before Intervention and 2 month After Intervention
Method of measurement
Pulsed Wave Doppler Echocardiography

Secondary outcomes

1

Description
Left ventricle mass
Timepoint
Before Intervention and 2 Month After Intervention
Method of measurement
2 Dimentional Echocardiography

2

Description
Blood Pressure
Timepoint
Before Intervention and 2 Month After Intervention
Method of measurement
Sphyngomanometer

3

Description
Functional Capacity
Timepoint
Before Intervention and 2 Month After Intervention
Method of measurement
Naghoutan Protocol

Intervention groups

1

Description
Rehabilitation program for 8-week course of aerobic exercise (three 60-minute sessions per week). Aerobic exercise including stretching exercises for warm-up, aerobic exercises on treadmill ergo meter, stepper and kayak equipment in 60-85% of maximum heart rate of each patient. Exercises will be prescribed for each participant individually, based on his physiological abilities.
Category
Rehabilitation

2

Description
2 month detraining for control group
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Chamran hospital
Full name of responsible person
Dr. mohamad Mehdi Hadavi
Street address
chamran H.Moshtagh2 A. Isfahan ,
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan Cardivascular Research Center
Full name of responsible person
Dr.masoumeh Sadeghi
Street address
Khoram A.Jomhori Eslami S.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 Cardivascular Research Center
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 Univercity
Full name of responsible person
Fatemeh Basati
Position
MA of physical education
Other areas of specialty/work
Street address
jahad 16 A., jahad, Isalam abad .Kermanshah
City
Islam Abad
Postal code
6761957655
Phone
+98 83 2524 1887
Fax
Email
basatifatemeh@yahoo.com: fatemeh.basati1987@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan university
Full name of responsible person
Fatemeh Basati
Position
MA of physical Education
Other areas of specialty/work
Street address
Jahad 16 A, Jahad, Islam Abad Gharb, Kermanshah
City
Islam Abad Gharb
Postal code
6761957655
Phone
+98 83 2524 1887
Fax
Email
basatifatemeh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan Univercity
Full name of responsible person
Fatemeh Basati
Position
MA of physical education
Other areas of specialty/work
Street address
Jahad 16، Islam abad ,Kermanshah
City
Islam abad
Postal code
6761957655
Phone
+98 83 2524 1887
Fax
Email
basatifatemeh@yahoo.com: fatemeh.basati1987@gmail.com
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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