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Comparison of home-based exercise rehabilitation with centre-based cardiac rehabilitation on lipid parameters, hematology and some behavioral indicators with coronary artery disease

Protocol summary

Summary
In this study, the Comparison of home-based exercise rehabilitation with centre-based cardiac rehabilitation on lipid parameters, hematology and some behavioral indicators with coronary artery disease is studied. Forty male and female patients with CABG or PCI (mean age 59 year) were divided into 3 groups: 1- home-based exercise rehabilitation, 2- centre –based CR and 3- control. Subjects of both home and centre based of cardiac rehabilitation started their activity for 8 weeks, 3 sessions per week about 60-90 minutes, while the control group was only followed-up and during this period they did not experience any exercise. Triglycerides, total cholesterol, high-density lipoprotein and low-density Lipoprotein, Fasting blood sugar, white blood cell, red blood cell, Platelets, Aspartate Aminotransferase, alanine aminotransferase, creatine phosphokinase, alkaline phosphatase, lactate dehydrogenase were measured at baseline and after 2 months of cardiac rehabilitation. The type A behavior, anger, pessimism, anxiety, depression and quality of life variables of patients were measured by standard questionnaires in the beginning and end of eight week exercise rehabilitation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014092319272N1
Registration date: 2015-03-24, 1394/01/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-03-24, 1394/01/04
Registrant information
Name
Azam Moosavi Sohroforouzani
Name of organization / entity
University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 5263 8240
Email address
azamsadat_moosavi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Faculty of Physical Education & Sport Science, Isfahan University
Expected recruitment start date
2013-11-21, 1392/08/30
Expected recruitment end date
2014-04-19, 1393/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of home-based exercise rehabilitation with centre-based cardiac rehabilitation on lipid parameters, hematology and some behavioral indicators with coronary artery disease
Public title
Home-based exercise rehabilitation and centre-based cardiac rehabilitation
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: patients with coronary artery disease after coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI); 3 months after coronary artery bypass surgery or coronary angioplasty; Surgical repair in patients. Exclusion criteria: Any adverse conditions or obstacles that interfere exercise intervention and assess the effectiveness of the training program is difficult; Diseases such as uncontrolled hypertension, arthritis, respiratory diseases, acute orthopedic problems and musculoskeletal pain were included; regular exercise Before entering the study.
Age
From 45 years old to 68 years old
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 Cardiovascular Research Institute
Street address
Isfahan Cardiovascular Research Institute, Khoram Avenue
City
Isfahan
Postal code
Approval date
2013-11-22, 1392/09/01
Ethics committee reference number
92117

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
LDH
Timepoint
The bigining and the end of the intervention
Method of measurement
U/L, Laboratory measurements

2

Description
SGOT
Timepoint
The bigining and the end of the intervention
Method of measurement
U/L, Laboratory measurements

3

Description
SGPT
Timepoint
The bigining and the end of the intervention
Method of measurement
U/L, Laboratory measurements

4

Description
ALK
Timepoint
The bigining and the end of the intervention
Method of measurement
U/L, Laboratory measurements

5

Description
HDL
Timepoint
The bigining and the end of the intervention
Method of measurement
Mg/dl, Laboratory measurements

6

Description
FBS
Timepoint
The bigining and the end of the intervention
Method of measurement
Mg/dl, Laboratory measurements

7

Description
CBC
Timepoint
The bigining and the end of the intervention
Method of measurement
Laboratory measurements

8

Description
LDL
Timepoint
The bigining and the end of the intervention
Method of measurement
Mg/dl, Laboratory measurements

9

Description
Cholesterol
Timepoint
The bigining and the end of the intervention
Method of measurement
Mg/dl, Laboratory measurements

10

Description
triglyceride
Timepoint
The bigining and the end of the intervention
Method of measurement
Mg/dl, Laboratory measurements

11

Description
Quality of life
Timepoint
The bigining and the end of the intervention
Method of measurement
Questionnaire SF36

12

Description
Anxiety
Timepoint
The bigining and the end of the intervention
Method of measurement
Questionnaire S.A.S

13

Description
Depretion
Timepoint
The bigining and the end of the intervention
Method of measurement
Questionnaire Beck

14

Description
Type A behavior
Timepoint
The bigining and the end of the intervention
Method of measurement
Questionnaire TAB

15

Description
Systolic blood pressure
Timepoint
The bigining and the end of the intervention
Method of measurement
Mercury sphygmomanometer, mmHg

16

Description
Diastolic blood pressure
Timepoint
The bigining and the end of the intervention
Method of measurement
Mercury sphygmomanometer, mmHg

Secondary outcomes

empty

Intervention groups

1

Description
Home-based exercise rehabilitation group: The subjects in this group participated in aerobic and resistance exercise at home for 8 weeks, 3 sessions per week about 60-90 minutes. The Home-based exercise program includes 10 min warm up, 5 min aerobic exercise, 5 min resistance exercise, 25–60 min brisk walking or jogging at an intensity of 11–13 on the Borg scale and 10 min cool down.
Category
Rehabilitation

2

Description
Centre-based cardiac rehabilitation group: During the study period of 8 weeks, all the study subjects participated 3 exercise sessions last 60-90 minutes, per week. The subjects in this group followed routine rehabilitation unit protocol that was 20 min warm up, 25–60 min aerobic, resistance and flexibility exercise on machines (e.g., treadmill, stationary bike, stepper, AB King Pro) at an intensity of 11–13 on the Borg scale and 10 min cool down.
Category
Rehabilitation

3

Description
control group: the control group was only followed-up and during this period they did not experience any exercise
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Cardiovascular Research Institute
Full name of responsible person
Azam Moosavi Sohroforouzani
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Isfahan, Faculty of Physical Education & Sport Science
Full name of responsible person
Dr. Fahimeh Esfarjani
Street address
Faculty of Physical Education & Sport Science, University of Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Isfahan, Faculty of Physical Education & Sport Science
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
University of Isfahan
Full name of responsible person
Azam Moosavi Sohroforouzani
Position
msc student
Other areas of specialty/work
Street address
Faculty of Physical Education & Sport Science, University of Isfahan
City
Isfahan
Postal code
Phone
+98 31 5263 8240
Fax
Email
azamsadat_moosavi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Azam Moosavi Sohroforouzani
Position
msc student
Other areas of specialty/work
Street address
Faculty of Physical Education & Sport Science, University of Isfahan
City
Isfahan
Postal code
Phone
+98 31 5263 8240
Fax
Email
azamsadat_moosavi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Azam Moosavi Sohroforouzani
Position
msc student
Other areas of specialty/work
Street address
Faculty of Physical Education & Sport Science, University of Isfahan
City
Isfahan
Postal code
Phone
Fax
Email
azamsadat_moosavi@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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