Effect Of Long Term Combined Cardiac Rehabilitation And Yoga Training On Electrocardiogram Changes And Cardiac Autonomic System In Coronary Artery Patients After Surgery
The effect of long-term combined training, rehabilitation and yoga on electrocardiographic changes and cardiac autonomic system in post-operative coronary artery disease patients.
Design
Samples were performed from coronary artery bypass grafting patients in the Shahid Rajaee Cardiology Center, and they were cleared in Phase 2, were randomly selected. Patients are randomly assigned into two groups of rehab and yoga-rehabilitation. In order to blindness at this stage, the names of people in the envelope and the codes defined on them by one person (other than the anchors) in two groups of control (rehailiation exercise ( n=15)) and experimental group (combined exercise( n=15)) are randomly divided be.
Settings and conduct
The control group and the combined exercises group should be present at the rehabilitation department of Tehran's Shahid Rajaee Cardiology Hospital during the course of the project (8 weeks), weekly three sessions for 1 hour. The intensity of the rehabilitation exercises in this plan is between 60-85% of the maximum heart rate, depending on the subject's ability.
Participants/Inclusion and exclusion criteria
- Patients who have coronary artery bypass grafts and male gender.
- Do not use drugs or cigarettes.
- Non-use of unauthorized drugs and the use of similar drugs at the time of the study
- Having no history of heart attacks or heart failure
- Lack of movement disorders that prevent exercise in rehab.
- Lack of space more than 100 km from the center of rehab
- absence of ejection fraction less than 35%
- oral health control due to salivary measurements
Intervention groups
Control group (cardiac rehab)
Combined exercise training group (yoga and rehab)
Main outcome variables
Electrocardiogram changes,
Autonomic changes in the heart ( HRV, salivary cotisol & alpha amylase)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180728040615N1
Registration date:2018-12-14, 1397/09/23
Registration timing:retrospective
Last update:2018-12-14, 1397/09/23
Update count:0
Registration date
2018-12-14, 1397/09/23
Registrant information
Name
Fatemeh Fakharirad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4486 5223
Email address
phdfakhari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-30, 1397/02/10
Expected recruitment end date
2018-11-06, 1397/08/15
Actual recruitment start date
2018-06-21, 1397/03/31
Actual recruitment end date
2018-08-28, 1397/06/06
Trial completion date
2018-10-17, 1397/07/25
Scientific title
Effect Of Long Term Combined Cardiac Rehabilitation And Yoga Training On Electrocardiogram Changes And Cardiac Autonomic System In Coronary Artery Patients After Surgery
Public title
Effect of combined yoga and rehabilitation in CABG patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who underwent coronary artery bypass graft surgery in Shahid Rajai's Heart Hospital
45-75 years old.
At least one month have passed since surgery
Exclusion criteria:
Having a history of heart attacks, heart surgery or congestive heart failure
Major motor disturbances
Having more than 100 km distance from Shahid Rajaee Cardiac Rehabilitation Center in Tehran
Having ejection fraction at least 35%
Drug use and smoking
Age
From 45 years old to 75 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize at this stage, the names of people in the envelope and the codes defined on them by one person (except the administrators) in two groups of control (rehabilitation ) and experimental group (combined training) randomly Are divided.
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 Committee on Biomedical Research, Science and Research Branch, Islamic Azad University
Street address
Islamic Azad University of science & Reaserch branch, Tehran, Iran. Hesarak, Ashrafi ESfehani,
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Approval date
2018-03-04, 1396/12/13
Ethics committee reference number
IR.IAU.SRB.REC.1396.97
Health conditions studied
1
Description of health condition studied
coronary artery bypass grafting
ICD-10 code
I25.7
ICD-10 code description
Atherosclerosis of coronary artery bypass graft(s) and coronary artery of transplanted heart with angina pectoris
Primary outcomes
1
Description
Electerocardiographic changes
Timepoint
48 hours before the intervention begins and 48 hours after the end of the training period
Method of measurement
It is measured by an electrocardiogram device in the Shahid Rajaie Cardiology and Cardiology Hospital.
2
Description
cardiac autonomic changes
Timepoint
48 hours before the intervention begins and 48 hours after the end of the training period
Method of measurement
Measurement of heart rate variability with existing Holter device in Shahid Rajaee Heart Hospital, measurement of salivary alpha amylase and cortisol at rest
Secondary outcomes
1
Description
heart rate variability( HRV)
Timepoint
48 hours before the training period and 48 hours after the training period
Method of measurement
Holter monitoring 24 hours
2
Description
Salivary Cortisol
Timepoint
48 hours before and after of training period
Method of measurement
Take saliva in the form of fasting at rest in saliva special tubes
3
Description
Salivary amylase alpha
Timepoint
At the beginning of the study and 48 hours before the intervention, and 48 hours after the end of the intervention,
Method of measurement
Take saliva in the form of fasting at rest in saliva special tubes
Intervention groups
1
Description
Control group: cardiac rehabilitation training, Patients in this group have routine hospital rehab sessions that lasts eight weeks of training, three sessions per week for one hour, including aerobic exercises on a treadmill for 30 minutes, 20-30 minutes for arm and leg cycles.
Category
Rehabilitation
2
Description
Intervention group: combined training of yoga and cardiac rehabilitation, In this type of exercises, patients have three sessions each week for for eight weeks, for 1 hour per session. It performs a session of yoga practice and next session a routine rehearsal training .
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee Heart Hospital
Full name of responsible person
Fatemeh Fakhari Rad
Street address
Hashemi Rafsanjani Hwy,Shahid Rajaee Hospital
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
fakhari2013fatemeh@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Rajaee Heart Hospital
Full name of responsible person
Sara Lotfian
Street address
At The End Of Hashemi Rafsanjani High Way, Shahid Rajaee Heart Hospital
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
fakhari2013fatemeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Rajaee Heart Hospital
Proportion provided by this source
50
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
Islamic Azad University
Full name of responsible person
Fatemeh Fakhari Rad
Position
PHD Student Of Science & Reaserch Branch, Eslamic Azad University ,Tehran , Iran.
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Hesarak, Ashrafi Esfahani High Way
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5149
Email
fakhari2013fatemeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Fakhari Rad
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Hesarak, Ashrafi Esfahani High Way
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5149
Email
fakhari2013fatemeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Fakhari Rad
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Hesarak, Ashrafi Esfahani High Way
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5149
Email
fakhari2013fatemeh@gmail.com
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