Protocol summary

Summary
Objectives: To assess the effect of cardiac rehabilitation on myocardial performance index in patients undergoing coronary artery bypass surgery. Design: a before and after clinical trial. Setting and conduct: Eligible patients who are candidate for coronary artery bypass surgery and will refer to the Ekbatan Hospital during the study period will be enrolled in to the trial. Inclusion criteria: candidate for coronary artery bypass surgery. Exclusion criteria: (a) congenital musculoskeletal deformity; (b) acquired musculoskeletal deformity; (c) severe left ventricular dysfunction. Intervention: physiotherapy for 45 min for 30 sessions including 30 min walking on treadmill at a low speed, 10 min stationary cycling at a low speed, and 5 min stretching exercises. Control: comparison with the patients' condition before surgery. Primary outcome: Assessing the myocardial performance index before surgery and after cardiac rehabilitation using echocardiography. Secondary outcome: Assessing the ejection fraction before surgery and after cardiac rehabilitation using echocardiography.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201409289014N40
Registration date: 2014-10-07, 1393/07/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-10-07, 1393/07/15
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-05-20, 1392/02/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of cardiac rehabilitation on myocardial performance index in patients undergoing coronary artery bypass surgery: A before and after clinical trial
Public title
Effect of cardiac rehabilitation on myocardial performance index in patients undergoing coronary artery bypass surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: candidate for coronary artery bypass surgery. Exclusion criteria: (a) congenital musculoskeletal deformity; (b) acquired musculoskeletal deformity; (c) severe left ventricular dysfunction.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 65
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2013-05-19, 1392/02/29
Ethics committee reference number
D/P/16/35/9/711

Health conditions studied

1

Description of health condition studied
coronary artery bypass surgery
ICD-10 code
T82.2
ICD-10 code description
Mechanical complication of coronary artery bypass and valve grafts

Primary outcomes

1

Description
Assessing the myocardial performance index
Timepoint
before surgery and after cardiac rehabilitation
Method of measurement
using echocardiography

Secondary outcomes

1

Description
Assessing the ejection fraction
Timepoint
before surgery and after cardiac rehabilitation
Method of measurement
using echocardiography

Intervention groups

1

Description
physiotherapy for 45 min for 30 sessions including 30 min walking on treadmill at a low speed, 10 min stationary cycling at a low speed, and 5 min stretching exercises.
Category
Treatment - Other

2

Description
comparison with the patients' condition before surgery.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ekbatan Hospital
Full name of responsible person
Dr Hamid Reza Majidian
Street address
Ekbatan Hospital, Jahad Square
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Ekbatan Hospital
Full name of responsible person
Dr Hamid Reza Majidian
Position
Resident of Cardiology
Other areas of specialty/work
Street address
Ekbatan Hospital, Jahad Square, Hamadan
City
Hamadan
Postal code
Phone
+98 81 3825 1244
Fax
Email
mxm1356@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ekbatan Hospital
Full name of responsible person
Dr Amir Hossein Yazdi
Position
Cardiologist
Other areas of specialty/work
Street address
Ekbatan Hospital, Jahad Square, Hamadan
City
Hamadan
Postal code
Phone
+98 81 3825 1244
Fax
Email
A.yazdi@umsha.ac.ir
Web page address

Person responsible for updating data

Contact

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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