Protocol summary
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Study aim
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Evaluation of acupuncture on the effect of cardiac rehabilitation on blood pressure, heart rate, exercise tolerance in patients after open heart surgery
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Design
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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.
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Settings and conduct
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Cardiopulmonary rehabilitation Unit of Shahid Faghihi hospital. Researcher is blind about control group.
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Participants/Inclusion and exclusion criteria
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Patients who underwent Coronary Artery Bypass Graft surgery 6 weeks ago; uncontrolled heart failure
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Intervention groups
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First group، Acupuncture treatment after cardiac rehabilitation
Second group، just cardiac rehabilitation
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Main outcome variables
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Blood pressure, Heart rate, Borg scale
General information
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Reason for update
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Error in recording the start date of sample collection
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Acronym
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توانبخشی قلبی
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IRCT registration information
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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
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Registration date
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2019-06-18, 1398/03/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-07-23, 1398/05/01
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Expected recruitment end date
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2020-03-20, 1399/01/01
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Actual recruitment start date
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2019-07-23, 1398/05/01
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Actual recruitment end date
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2020-03-20, 1399/01/01
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Trial completion date
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2020-03-20, 1399/01/01
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Scientific title
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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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Public title
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effect of acupuncture on effectiveness of cardiac rehabilitation
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
40
Actual sample size reached:
34
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Choosing patients as a case or control with the help of the site: randomization.com
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The researcher does not have any role in choosing patients as a case or control group
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-02-16, 1396/11/27
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Ethics committee reference number
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IR.SUMS.MED.REC.1396.100
Health conditions studied
1
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Description of health condition studied
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Coronary Artery Disease
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ICD-10 code
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I21.0
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ICD-10 code description
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Ischemic Heart Disease
Primary outcomes
1
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Description
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Blood pressure
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Timepoint
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Before the intervention and three weeks after intervention
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Method of measurement
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Sphygmomanometer
Secondary outcomes
1
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Description
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Exercise tolerance
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Timepoint
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Before the intervention and three weeks after intervention
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Method of measurement
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Borg questionnaire
Intervention groups
1
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Description
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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)
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Category
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Rehabilitation
2
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Description
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Control group: 10 sessions cardiac rehabilitation with treadmill and arm ergometer, 3 days in week
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Shiraz University of Medical Science
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available