This study investigate the effect of cardiac rehabilitation on heart rate , blood pressure , exercise capacity and quality of life in patients with ischemic heart disease .
Patients with at least 4 weeks after diagnosis of ischemic heart disease and currently, has not secondary complications including arrhythmia or heart failure and physically able to participate in a rehabilitation program.200 patients referred to the heart department of the Shahid Beheshti Hospital of Kashan from december 2010 to december 2011, randomized in two groups.Control group receive routine medical care program after ischemic heart diseases.The other receive an 8 weeks cardiac rehabilitation. Befor and after 8 weeks each patient do an exercise test to compare.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103146059N1
Registration date:2011-12-20, 1390/09/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-20, 1390/09/29
Registrant information
Name
Hassan Rajabi Moghadam
Name of organization / entity
Beheshti Hospital
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
rajabi_ha@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2011-10-23, 1390/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of the effect of cardiac rehabilitation program on clinical and paraclinical findings of patients with ischemic heart disease
Public title
Effects of cardiac rehabilitation in ischemic heart diseases
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Ischemic heart disease;Physically ability to do exercise test.
Exclusion criteria: Less than 4 weeks from ischemic heart diagnosis; Heart failure ; Sever hypertension; Arrhythmia.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
111 / 87155, Ravandi Blvd ,Kashan
City
Kashan
Postal code
Approval date
2008-09-16, 1387/06/26
Ethics committee reference number
1818/1/5/20/پ
Health conditions studied
1
Description of health condition studied
Ischaemic heart disease
ICD-10 code
I25.8
ICD-10 code description
Other forms of chronic ischaemic heart disease
Primary outcomes
1
Description
Duration of chest pain
Timepoint
Before and after cardiac rehabilitation program
Method of measurement
Questionnaire
2
Description
Systolic blood pressure at rest
Timepoint
Before and after cardiac rehabilitation program
Method of measurement
Per mm Hg using a mercury barometer
3
Description
Diastolic blood pressure at rest
Timepoint
Before and after cardiac rehabilitation program
Method of measurement
Per mm Hg using a mercury barometer
4
Description
Exercise Tolerance
Timepoint
Before and after cardiac rehabilitation program
Method of measurement
Duration of exercise Per minute
5
Description
Maximum oxygen consumption.
Timepoint
Before and after cardiac rehabilitation program
Method of measurement
exercise tolerance test per METS
6
Description
Cholesterol
Timepoint
Before and after cardiac rehabilitation program
Method of measurement
Per mg / dl
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group, in addition to routine treatment programs, also receive rehabilitation programs the results of clinical and paraclinical findings will be recorded.A cardiologist examine patients in rehabilitation sessions, and their clinical symptoms are recorded by medical student. At the same time for Para clinical studies, 10cc , fasting blood was taken with the consent of the patient and sent to the laboratory.This is done in two sessions (pre-rehabilitation program and at the end of an 8-week rehabilitation program). Rehabilitation program include, a three-week aerobic exercise session, 2 sessions of training - is consulting. Exercise sessions included 50 minutes warm-up, isometric exercises for 30 minutes, and 10 minutes cooling down. Training sessions include nutrition education, lifestyle modification, , weight loss, exercise in everyday activities, avoid heavy activity that can lead to fatigue and shortness of breath. Learning how to keep control of vital signs, including pulse, blood pressure, avoid extreme heat and cold, proper diet, limit salt and alcohol and fat consumption, To encourage consumption of fresh vegetables and fruit, and cereal fiber consumption, quit smoking and alcohol.Also investigate and resolve the problems they cause.
Category
Rehabilitation
2
Description
Control group: routine treatment programs receive.Include all control program except Exercise sessions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Heart department-Beheshti hospital
Full name of responsible person
Hassan rajabi Moghadam
Street address
City
Beheshti hospital,Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hasan Rajabi moghadam
Street address
Beheshti Hospital
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Hasasn Rajabi Moghadam
Position
Cardiologist/Assistant Professor
Other areas of specialty/work
Street address
Beheshti Hospital-Kashan
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
Email
rajabi_ha@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fariba Raygan
Position
Cardiologist
Other areas of specialty/work
Street address
Beheshti Hospital,Ravandi Blvd,Kashan
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
Email
dr.alireza_hosseini@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Alireza Hosseini
Position
MD/Resident
Other areas of specialty/work
Street address
Beheshti Hospital, Kashan
City
Kashan
Postal code
Phone
Fax
Email
dr.alireza_hosseini@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)