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Effect of cardiac rehabilitation on endothelial function and HbA1c in diabetic patients with Ischemic Heart disease

Protocol summary

Summary
Objective: To evaluate the effect of cardiac rehabilitation on endothelial function and HbA1c in patients with diabetes and ischemic heart disease. Study Design: Non-randomized study. Inclusion criteria; patients with type 2 diabetes have proved that diabetes treated with oral diabetes medications, PCI or CABG with recent history for rehabilitation are introduced. Exclusion criteria; patients who smoke and those who have been smoking during the past 5 years are excluded. Cardiovascular disorders and complications that require close care specialist such as severe ventricular arrhythmias and other serious complications. Intervention: Cardiac rehabilitation. Sample: A total of 53 intervention. Groups: One month after CABG, and two weeks after PCI. Primary outcome: Change in ABI and HBA1C. Secondary outcomes: Changes in GFR, FBS, lipid profile, BMI and METS. This study with a control group of 25 people, including the rehabilitation of diabetic patients with Ischemic Heart Disease is not done for them, all testing groups, including CBC, FBS , BUN, Cr, TG, CHOL, LDL, HDL and HbA1C in the control group and ABI asking twice, beginning and after two months out. And compared the results with the experimental group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015091924089N1
Registration date: 2015-12-02, 1394/09/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-12-02, 1394/09/11
Registrant information
Name
Masoumeh Mohammadirad
Name of organization / entity
Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 4352 9921
Email address
mohammadirad.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz University of Medical Sciences
Expected recruitment start date
2015-09-20, 1394/06/29
Expected recruitment end date
2015-11-20, 1394/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of cardiac rehabilitation on endothelial function and HbA1c in diabetic patients with Ischemic Heart disease
Public title
Effect of cardiac rehabilitation on vascular function and glycemic condition in diabetic patients with Ischemic Heart disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Diabetic patients treated with oral blood glucose lowering drugs, with history of CABG or PCI, they refer for Cardiac Rehabilitation Center of Imam Khomeini Hospital. Exclusion criteria: Smokers and those who have been smoking during the past 5 years are excluded؛ The reluctance of patients to participate in the study and not personal consent by the patient؛ Recurrent infarct during the study؛ Cardiovascular disorders and complications that require close care specialist such as severe ventricular arrhythmias and other serious complications؛ Treatment of diabetes with insulin؛
Age
No age limit
Gender
Both
Phase
2-3
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 Ahvaz University of Medical Sciences
Street address
Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz
City
Ahvaz
Postal code
61357-15794
Approval date
2015-05-23, 1394/03/02
Ethics committee reference number
IR.AJUMS.REC.1394.89

Health conditions studied

1

Description of health condition studied
Ischemic Heart Disease
ICD-10 code
I20, I21,
ICD-10 code description
Ischaemic heart diseases

Primary outcomes

1

Description
Ankle Brachial Index
Timepoint
Before and after intervention
Method of measurement
By Vascular Screening Device VaSeraVS-1500N model

2

Description
HbA1C
Timepoint
Before and after intervention
Method of measurement
HbA1c blood and laboratory use

Secondary outcomes

1

Description
METS
Timepoint
Before and after study
Method of measurement
The Duke questionnaire

2

Description
Fasting Blood Suger
Timepoint
Before and after study
Method of measurement
Blood Sample

3

Description
Blood Pressure
Timepoint
Before and after study
Method of measurement
By Manometer

4

Description
Glomerular filtration rate
Timepoint
Before and after study
Method of measurement
Cockcroft-Gault Equation

5

Description
Body Mass Index
Timepoint
Before and after study
Method of measurement
The ratio of height to weight

6

Description
Lipid Profil
Timepoint
Before and after study
Method of measurement
Blood Sample

Intervention groups

1

Description
Intervention: cardiac rehabilitation, which includes a period of 1 hour exercise, including warm-up period of about 10 minutes, then 40 minutes of exercise with a treadmill, stationary bike or exercising arm (according to the protocol outlined monitoring each patient) and finally cooling period is for about 10 minutes. Cardiac monitoring is done during exercise. Total cardiac rehabilitation program is 24 sessions.
Category
Rehabilitation

2

Description
The control group included patients with a history of Cardiovascular disease who are treated with anti- ischemic drugs.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Cardiovascular Rehabilitation Center, Imam Khomeini Hospital, Azadegan Street, Ahvaz, Khoozestan Pro
Full name of responsible person
M. Mohammadi Rad Resident of Cardiology
Street address
Cardiovascular Rehabilitation Center, Imam Khomeini Hospital, Azadegan Street, Ahvaz, Khoozestan Province, Iran
City
Ramhormoz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research univercity of ahvaz
Full name of responsible person
Dr.Nader Saki
Street address
Vice chancellor for research, Ahvaz Univercity of Medical Science, Golestan Blvd, Ahvaz, Khoozestan Province, Iran
City
Ahvaz
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 univercity of ahvaz
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
Ahvaz University of Medical Sciences
Full name of responsible person
Masoumeh Mohammadirad
Position
Assistant Professor of Cardiology
Other areas of specialty/work
Street address
No. 69, Zidane alley, Salman Farsi, Ramhormoz
City
Ramhormoz
Postal code
Phone
+98 61 4352 9921
Fax
Email
masoumemohammadirad@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ahmad Reza Assareh
Position
Professor of Cardiology / Assistant
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Azadegan Street, Ahvaz, Khoozestan, Iran
City
Ahvaz
Postal code
Phone
+98 61 3222 8037
Fax
Email
assareh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Masoumeh Mohammadirad
Position
Assistant Professor of Cardiology
Other areas of specialty/work
Street address
No. 69, Zidane alley, Salman Farsi, Ramhormoz, Khoozestan, Iran
City
Ramhormoz
Postal code
Phone
+98 61 4352 9921
Fax
Email
masoumemohammadirad@yahoo.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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