Purpose:
The effect of exercise-based cardiac rehabilitation on blood pressure, lipid profiles, renal function, blood sugar, BMI, ABI and patient MET'S.
Study design: Randomized clinical trial.
Study population: Smokers with ischemic heart disease.
Inclusion criteria: Patients with a history of ischemic heart disease who currently smoke or quit smoking less than 5 years since the last of them.
Exclusion criteria:
Patients with Diabetes (type 1,2).
The reluctance of patients to participate in the study and not personal consent by the patient.
Re infarction during the study.
Cardiovascular disorders and complications that require close care specialist such as severe ventricular arrhythmias and other serious complications.
Sample volume: 53
Case study: the role of cardiac rehabilitation on vascular endothelial function.
Intervention time: One month after cardiac surgery(CABG) and two weeks after stenting(PCI).
Primary outcomes of the study:
The effect of rehabilitation on the ABI.
Secondary outcomes:
The effect of rehabilitation on blood pressure, blood sugar, lipid profile, renal function, MET'S and BMI.
Rehabilitation for 3 sessions per week, each session of one hour for 8 week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092224146N1
Registration date:2015-10-20, 1394/07/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-20, 1394/07/28
Registrant information
Name
Mrzieh Jafarpoor
Name of organization / entity
Ahwaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 4222 4739
Email address
jafarpor.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Univercity of Medical Research Resources
Expected recruitment start date
2015-09-26, 1394/07/04
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of cardiac rehabilitation on endothelial function in smoker patients with ischemic heart disease
Public title
Effect of cardiac rehabilitation on endothelial function in smoker patients with athero sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a history of ischemic heart disease who currently smoke or have quit less than 5 years.
Exclusion criteria:
Patients with Diabetes (type 1,2)
The reluctance of patients to participate in the study and not personal consent by the patient.
Re infarction during the study.
Cardiovascular disorders and complications that require close care specialist such as severe ventricular arrhythmias and other serious complications.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
53
Randomization (investigator's opinion)
Not 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
Ethics Committee of the University of Medical Sciences Jundi Shapur Ahwaz
Street address
Golestan Blvd., University Town, near the center of Ahwaz Jundi Shapur University of Medical Sciences and Health Services, Department of Research and Technology, PO Box 45. Ahwaz
City
Ahwaz
Postal code
15794 - 61357
Approval date
2015-05-23, 1394/03/02
Ethics committee reference number
IR.AJUMS.REC.1394.81
Health conditions studied
1
Description of health condition studied
Ischemic heart disease
ICD-10 code
120-125
ICD-10 code description
Ischaemic heart diseases
Primary outcomes
1
Description
Measurement of ankle-brachial pressure
Timepoint
Before the start of rehabilitation and completion after 24 sessions
Method of measurement
Ankle blood pressure devided by brachial blood pressure by manometer
Secondary outcomes
1
Description
The effect of rehabilitation on MET'S (metabolic equivalents [of oxygen consumption])
Timepoint
Before the start of rehabilitation and after 24 sessions
Method of measurement
By questionnaire Duke Activity Status Index
2
Description
The effect of rehabilitation on blood suger
Timepoint
Before the start of rehabilitation and after 24 sessions
Method of measurement
By measuring fasting blood glucos
3
Description
The effect of rehabilitation on renal function
Timepoint
Before the start of rehabilitation and after 24 sessions
Method of measurement
By measuring of GFR
4
Description
The effect of rehabilitation on blood pressure
Timepoint
Before the start of rehabilitation and after 24 sessions
Method of measurement
Blood pressure measurement by manometer
5
Description
The effect of rehabilitation on body mass index
Timepoint
Before the start of rehabilitation and after 24 sessions
Method of measurement
Through height and weight (the weight in kilograms by height in meters squared)
6
Description
The effect of rehabilitation on lipid profile
Timepoint
Before the start of rehabilitation and after 24 sessions
Method of measurement
By measuring triglyceride, cholesterol, HDL, LDL
Intervention groups
1
Description
Control group:
The control group did not rehabilitation. All tests are intended for groups such as blood sugar, lipid profile, renal function and pressure ratio of ankle to brachial at baseline and then measured after two months .
Category
N/A
2
Description
Intervention Groups:
Rehabilitation that patients exercise protocol consists of a one-hour period early on soft, about 10 minutes, and then a treadmill or stationary bike for forty minutes and finally for 10 minutes is the final exercise period.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Rehabilitation Center in Ahwaz
Full name of responsible person
Marzieh Jafarpoor- Resident of Cardiology
Street address
Azadegan Street,Ahwaz
City
Dezful
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Ahwaz Jondi Shapoor University of Medical Sciences
Full name of responsible person
Dr. Nader saki
Street address
Ahwaz Jondi Shapoor University of Medical Sciences, Vice Chancellor for research ,Golestan Blvd,
City
Ahwaz
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 of Ahwaz Jondi Shapoor 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
Department of Cardiology, Ahwaz Jundi Shapur University of Medical Sciences
Full name of responsible person
Marzieh Jafarpoor
Position
Resident of Cardiology
Other areas of specialty/work
Street address
Imam Khomeini Hospital,Azadegan Street,, Ahwaz
City
Ahwaz
Postal code
6193673166
Phone
+98 61 3221 6504
Fax
+98 61 3221 6504
Email
himam@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Cardiology, Ahwaz Jundi Shapur University of Medical Sciences
Full name of responsible person
Ahmad Reza Assareh
Position
Cardiovascular Fellowship
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Azadegan Street,
City
Ahwaz
Postal code
6193673166
Phone
+98 61 3221 6504
Fax
+98 61 3221 6504
Email
himam@ajums.ac.ir ;assareh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jundi Shapur University of Medical Sciences, Department of Cardiology
Full name of responsible person
Marzieh Jafarpoor
Position
Resident of Cardiology
Other areas of specialty/work
Street address
, Imam Khomeini Hospital, Azadegan Street ,Ahwaz
City
Ahwaz
Postal code
6193673166
Phone
+98 61 3221 6504
Fax
+98 61 3221 6504
Email
himam@ajums.ac.ir ; Ma.jafarpor@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)