Protocol summary

Summary
The purpose of this study was to determine the effects of physical activity on quality of life of patients after coronary artery surgery. In a randomized clinical trial the quality of life of 70 patients under CABG was compared together(35 intervention,35 control). Patients at the discharge randomly divided to two groups. Inclusive criteria included a native؛ first time CABG؛ hemodynamic signals in the normal range؛ no impairment of sensory, motor, and auditory. Exclusion criteria for this study was redo CABG؛ re hospitalization during the study؛ chest pain؛ changes electrocardiography؛ the patient's intolerance؛ severe hemodynamic changes that jeopardize the patient's life؛ and death of the patient. The intervention on the case patients was physical activity that performed in 24-32 session three time in week and compiled of 20 minutes warming,20-40minutes aerobic exercise, 5 minutes cooling and 20 minutes relaxation. Control group have not any intervention.The mean scores of quality of life in two groups was compared two time(1 month and four month after intervention) with SF36 scoring.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111258194N1
Registration date: 2012-02-01, 1390/11/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-02-01, 1390/11/12
Registrant information
Name
Asghar Sherafat
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1721 1297
Email address
as_sherafat@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Yazd University of Medical Sciences.
Expected recruitment start date
2010-07-23, 1389/05/01
Expected recruitment end date
2011-08-11, 1390/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of physical activity on quality of life of patients after coronary artery bypass graft
Public title
Effects of physical activity on quality of life of patients after coronary artery bypass graft
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusive criteria included a native؛ first time CABG؛ hemodynamic signals in the normal range؛no impairment of sensory, motor, and auditory. Exclusion criteria for this study was redo CABG؛ re hospitalization during the study؛ chest pain؛ changes electrocardiography؛ the patient's intolerance؛ severe hemodynamic changes that jeopardize the patient's life؛ and death of the patient.
Age
From 35 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Ethics in Researches of Medical Sciences of Vice Chancellor for Research of Yazd University of Medic
Street address
Vice Chancellor for Research, University of Medical Sciences, Shahid Bahonar Square, Yazd
City
Yazd
Postal code
8916978477
Approval date
2011-03-12, 1389/12/21
Ethics committee reference number
135697

Health conditions studied

1

Description of health condition studied
CABG
ICD-10 code
T 82.2,T 8
ICD-10 code description
Complications (from) (of) - coronary artery (bypass) graft - mechanical T82.2, Complications (from) (of) - coronary artery (bypass) graft - mechanical T82.2

Primary outcomes

1

Description
quality of life
Timepoint
Pre intervention and 3 months after intervention
Method of measurement
SF36 quality of life Questionnaire

Secondary outcomes

1

Description
Heart rate and rythm
Timepoint
Pre intervention and 3 months after intervention
Method of measurement
space lab monitoring

Intervention groups

1

Description
The Program include 24 to 32 sessions of physical activity three times a week for an hour to an hour and a half. Each session includes 20 minutes warm-up exercises, 20 to 40 minutes of aerobic exercise (such as bicycle and treadmill) based on the patient's condition and severity of maximum heart rate(60 to 80 percent of maximum heart rate)'5 minute cooling and 20 minutes relaxation.The patients ECG, heart rate and blood pressure monitors during physical activity.At the end of last session the quality of life scoring repeated.
Category
Rehabilitation

2

Description
No intervention in control group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Heart Clinic of Afshar Hospital
Full name of responsible person
Sherafat Asghar
Street address
Heart Clinic of Afshar Hospital, Jomhoory street, Yazd, Iran
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Yazd University of Medical Sciences.
Full name of responsible person
Motevasselian Monireh
Street address
Vice Chancellor for Research, University of Medical Sciences, Shahid Bahonar Square, Yazd
City
Yazd
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, Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Sherafat Asghar
Position
BS
Other areas of specialty/work
Street address
Afshar Hospital, Jomhoory Street, Yazd, Iran
City
Yazd
Postal code
8917156735
Phone
+98 35 1525 6012
Fax
Email
as_sherafat@ssu.ac.ir; asgharsherafat@gmail.com; as_sherafat@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Sherafat Asghar
Position
BS
Other areas of specialty/work
Street address
Afshar Hospital, Jomhoory Street, Yazd, Iran
City
Yazd
Postal code
8917156735
Phone
+98 35 1525 6012
Fax
Email
as_sherafat@ssu.ac.ir; asgharsherafat@gmail.com; as_sherafat@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Sherafat Asghar
Position
BS
Other areas of specialty/work
Street address
Afshar Hospital, Jomhoory street, Yazd, Iran
City
Yazd
Postal code
8917156735
Phone
+98 35 1525 5011
Fax
Email
as_sherafat@ssu.ac.ir; asgharsherafat@gmail.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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