Investigating the effect of acupuncture and cardiac rehabilitation on patients after percutaneous coronary intervention in comparison to cardiac rehabilitation alone
The aim of this study is to assess the possible improvements in the symptoms of patients with percutaneous coronary intervention after cardiac rehabilitation combined with acupuncture in comparison with cardiac rehabilitation alone, on blood pressure (systolic and diastolic) and heart pulse rate.
Design
The study population consisted of 50 patients with a history of (PCI) who are referred to Shaheed Faghihi hospital in Shiraz and will be randomly divided into two groups: A and B (25 People in each group). Demographic characteristics of both groups in terms of age and sex are similar. To randomize the study, a randomized block method is used.
Settings and conduct
This is a randomized clinical trial that will be conducted on referrals to physicians and rehabilitation clinics of Shaheed Faghihi Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: completing informed consent; patients with cardiac diseases 6 weeks to 3 months after stent insertion. Exclusion criteria: diabetes with uncontrolled blood sugar; rheumatic diseases and collagen and vascular disease; bleeding disorder; inability to communicate and complete questionnaires; history of significant liver and kidney disorders; systolic blood pressure ≥ 200 mm Hg or diastolic blood pressure ≥ 110 mm Hg; uncontrolled arrhythmia; uncontrolled congestive heart failure and acute pericarditis or myocarditis.
Intervention groups
Treatment in group A includes acupuncture interventions on area related to heart meridian for 30 minutes and 10 courses before starting the cardiac rehabilitation process. Group B treatment includes only cardiac rehabilitation process for 10 courses.
Main outcome variables
More possible improvements in the cardiac function of patients with percutaneous coronary intervention after cardiac rehabilitation combined with acupuncture in comparison with cardiac rehabilitation alone.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140126016372N3
Registration date:2019-02-02, 1397/11/13
Registration timing:retrospective
Last update:2019-02-02, 1397/11/13
Update count:0
Registration date
2019-02-02, 1397/11/13
Registrant information
Name
Farzad Nikaein
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1726 2850
Email address
nikaeinf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-01, 1397/05/10
Expected recruitment end date
2018-10-01, 1397/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of acupuncture and cardiac rehabilitation on patients after percutaneous coronary intervention in comparison to cardiac rehabilitation alone
Public title
Investigating the effect of acupuncture and cardiac rehabilitation on patients after percutaneous coronary intervention
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Completing informed consent
Patients with cardiac diseases 6 weeks to 3 months after stent insertion
Exclusion criteria:
Diabetes with uncontrolled blood sugar, rheumatic diseases and collagen and vascular disease
Bleeding disorder, inability to communicate and complete questionnaires
History of significant liver and kidney disorders
Systolic blood pressure ≥ 200 mm Hg.
Diastolic blood pressure ≥ 110 mm Hg.
Uncontrolled Arrhythmia, Uncontrolled congestive heart failure, Acute pericarditis or myocarditis
Age
From 45 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In the randomization process, the envelopes containing letters A and B are used so that the letters inside the envelopes are not recognizable from the outside, as well as the manner in which the envelopes are placed randomly in succession and the person present at the time The randomization of content and the ordering of information in envelopes is not known.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and investigators do not know which patient is in the treatment group and only the patients are known under the names of groups A and B.
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
Central Building of Shiraz University of Medical Sciences, opposite Palestine Street, Zand Ave., Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2018-07-24, 1397/05/02
Ethics committee reference number
IR.SUMS.MED.REC.1397.135
Health conditions studied
1
Description of health condition studied
Ischemic heart diseases
ICD-10 code
Z98.61
ICD-10 code description
Coronary angioplasty status
Primary outcomes
1
Description
Blood Pressure (systolic and diastolic)
Timepoint
In both groups before and after each course of cardiac rehabilitation with or without acupuncture for 10 courses.
Method of measurement
Beurer upper arm digital blood pressure monitor
2
Description
Heart pulse rate
Timepoint
In both groups before and after each course of cardiac rehabilitation with or without acupuncture for 10 courses.
Method of measurement
Beurer digital pulse rate monitor device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before starting the cardiac rehabilitation process, acupuncture intervention will be done on area related to heart meridian with needle vertically (CUN 0.3 -1) for 30 minutes and 10 courses.
Category
Rehabilitation
2
Description
Control group: Only cardiac rehabilitation process.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Faghihi Hospital
Full name of responsible person
Farzam Ahmadipoor
Street address
Shaheed Faghihi Hospital, Zand Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3212 7001
Email
faghihi@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sharareh Roshanzamir
Street address
Shaheed Faghihi Hospital, Zand Avenue
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3231 9040
Email
crc@sums.ac.ir
Grant name
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
Rehabilitation management
Street address
Shiraz-Zand St.-Shaheed Faghihi Hospital, Department of Rehabilitation
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3231 9040
Email
nikaeinf@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzam Ahmadipoor
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Department of Rehabilitation, Shahid Faghihi Hospital, Zand St.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3231 9040
Email
nikaeinf@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzam Ahmadipoor
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Department of Rehabilitation, Shahid Faghihi Hospital, Zand St.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3231 9040
Email
nikaeinf@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD