evaluation of acupuncture on the effectiveness of cardiac rehabilitation in blood pressure and heart rate of patients after coronary artery bypass graft(CABG)
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General information
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34
34
2017-12-21, 1396/09/30
2019-07-23, 1398/05/01
20172019-1207-2123 00:00:00
2019-06-20, 1398/03/30
2020-03-20, 1399/01/01
20192020-0603-20 00:00:00
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2019-07-23, 1398/05/01
2019-07-23 00:00:00
empty
2020-03-20, 1399/01/01
2020-03-20 00:00:00
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2020-03-20, 1399/01/01
2020-03-20 00:00:00
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Error in recording the start date of sample collection
Error in recording the start date of sample collection
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خطا در ثبت تاریخ شروع جمع آوری نمونه
خطا در ثبت تاریخ شروع جمع آوری نمونه
Protocol summary
Study aim
Evaluation of acupuncture on the effect of cardiac rehabilitation on blood pressure, heart rate, exercise tolerance in patients after open heart surgery
Design
In this research, 40 eligible patients referring to cardiac rehabilitation Clinic were chosen and were randomly divided into two groups of control and intervention. Group allocation was concealed by assigning a unique code to each participants.
Settings and conduct
Cardiopulmonary rehabilitation Unit of Shahid Faghihi hospital. Researcher is blind about control group.
Participants/Inclusion and exclusion criteria
Patients who underwent Coronary Artery Bypass Graft surgery 6 weeks ago; uncontrolled heart failure
Intervention groups
First group، Acupuncture treatment after cardiac rehabilitation
Second group، just cardiac rehabilitation
Main outcome variables
Blood pressure, Heart rate, Borg scale
General information
Reason for update
Error in recording the start date of sample collection
Acronym
توانبخشی قلبی
IRCT registration information
IRCT registration number:IRCT20171208037793N1
Registration date:2019-06-18, 1398/03/28
Registration timing:prospective
Last update:2022-11-02, 1401/08/11
Update count:1
Registration date
2019-06-18, 1398/03/28
Registrant information
Name
Mohadese zakeri baghestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3375 5845
Email address
m_zakeri@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
2019-07-23, 1398/05/01
Actual recruitment end date
2020-03-20, 1399/01/01
Trial completion date
2020-03-20, 1399/01/01
Scientific title
evaluation of acupuncture on the effectiveness of cardiac rehabilitation in blood pressure and heart rate of patients after coronary artery bypass graft(CABG)
Public title
effect of acupuncture on effectiveness of cardiac rehabilitation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who underwent Coronary Artery Bypass Graft since 6 weeks to 3 month ago
Exclusion criteria:
Systolic blood pressure greater than 200
Diastolic blood pressure greater than 110
Acute illness
Uncontroled Aarrythmia
Uncompensated Heart failure
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
40
Actual sample size reached:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Choosing patients as a case or control with the help of the site: randomization.com
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher does not have any role in choosing patients as a case or control group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shiraz university of medical sciences
Street address
Zand Avenue, opposite Palestine Street, Central Building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Approval date
2018-02-16, 1396/11/27
Ethics committee reference number
IR.SUMS.MED.REC.1396.100
Health conditions studied
1
Description of health condition studied
Coronary Artery Disease
ICD-10 code
I21.0
ICD-10 code description
Ischemic Heart Disease
Primary outcomes
1
Description
Blood pressure
Timepoint
Before the intervention and three weeks after intervention
Method of measurement
Sphygmomanometer
Secondary outcomes
1
Description
Exercise tolerance
Timepoint
Before the intervention and three weeks after intervention
Method of measurement
Borg questionnaire
Intervention groups
1
Description
Intervention group: patients with Coronary Artery Bypass Graft that underwent acupuncture after cardiac rehabilitation(10 sessions, 3 days in week, on determined acupoints with acupuncture needles size 25*25 bong bang factory for 20 minutes)
Category
Rehabilitation
2
Description
Control group: 10 sessions cardiac rehabilitation with treadmill and arm ergometer, 3 days in week
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid faghihi hospital
Full name of responsible person
Sharareh roshanzamir
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۴۱۱۹
Phone
+98 71 3235 1090
Email
Faghihihsp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr seed Basir Hashemi
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3235 7282
Email
Hashemib@sums.ac.ir
Grant name
Shiraz University of Medical Science
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sharareh roshanzamir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 323572820710098
Email
Sharareh.roshanzamir@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sharareh Roshanzamir
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Zand avenu
City
Shiraz
Province
Fars
Postal code
7194685791
Phone
+98 71 3231 9040
Email
m_zakeri@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohadese Zakeri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Zand
City
Shiraz
Province
Fars
Postal code
3358746987
Phone
+98 76 3375 5845
Email
m_zakeri@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available