The effect of long-term combination training (rehabilitation-yoga) on some of the pre-inflammatory factors and depression levels in coronary artery disease patients after surgery.
The effect of long-term combination therapy (rehabilitation-yoga) on some of the pre-inflammatory factors and depression levels in coronary artery disease patients after surgery.
Design
Samples were randomly selected from male patients who underwent coronary artery bypass graft surgery at the Shahid Rajaie Cardiology Center and were in Phase 2 discharge. Patients are randomly assigned into two groups of rehab and yoga-rehabilitation.In order to randomize at this stage, the names of people in the envelope and the codes defined on them by one person (other than the administrators) in two groups of control (rehearsal practice) and experimental group (combined practice) randomly Are divided
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 per week.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 with coronary artery bypass grafts and male gender.Use of the same drugs at the time of the study.No history of heart surgery - no motor and orthopedic problems -Not having distance more than 100 km from the rehab center - ejection fraction no less than 35%.
Intervention groups
Control group (cardiac rehabilitation) Combined practice group (yoga and rehabilitation)
Main outcome variables
pre-inflammatory factors(ptx-3, IL-6,CRP) and depression levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181224042084N1
Registration date:2019-01-15, 1397/10/25
Registration timing:registered_while_recruiting
Last update:2019-01-15, 1397/10/25
Update count:0
Registration date
2019-01-15, 1397/10/25
Registrant information
Name
Zahra Fathollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4407 4244
Email address
mahsafathollahi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-01, 1397/04/10
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of long-term combination training (rehabilitation-yoga) on some of the pre-inflammatory factors and depression levels in coronary artery disease patients after surgery.
Public title
The effect of yoga combinations and cardiac rehabilitation in CABG patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
CABG surgery patients
Between 45 to 75 years old
Discharge phase
Sex:male
Up to 35% ejection fraction
Use of the same drugs at the time of the study
Exclusion criteria:
Not having more than 100 km distance from the Rehab center
No history of heart surgery
No motor and orthopedic problems
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
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 (other than the administrators) in two groups of control (rehearsal practice) and experimental group (combined practice) 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 Unit, Islamic Azad University
Street address
Islamic Azad University, Science and Research Branch,Hesarak, End of Ashrafi Isfahani, Tehran,Iran.
City
Tehran
Province
Tehran
Postal code
1477893855
Approval date
2018-03-04, 1396/12/13
Ethics committee reference number
IR.IAU.SRB.REC.1396.98
Health conditions studied
1
Description of health condition studied
CABG surgery patients
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
change in pre inflammatory factors
Timepoint
24 hours before the intervention begins and 24 hours after the end of the
Method of measurement
collecting 10 CC of Blood samples during rest in the fasting state
2
Description
Depression levels
Timepoint
24 hours before the intervention begins and 24 hours after the end of the training period
Method of measurement
Completing SCL-90 questionnaire
Secondary outcomes
1
Description
PTX-3-Blood Pre -inflammatory factors
Timepoint
24 hours before the intervention begins and 24 hours after the end of the training period
Method of measurement
10 CC of Blood samples are collected at rest in the fasting state
2
Description
(CRP)Blood Pre -inflammatory factors
Timepoint
24 hours before the intervention begins and 24 hours after the end of the training period
Method of measurement
10 CC of Blood samples are collected at rest in the fasting state
3
Description
IL-6(Blood Pre -inflammatory factors)
Timepoint
24 hours before the intervention begins and 24 hours after the end of the training period
Method of measurement
10 CC of Blood samples are collected at rest in the fasting state
Intervention groups
1
Description
Control group:8 weeks/ per weeks three tines about 1 hour Routine Cardiac rehabilitation program Includes 30 minutes walking on treadmill, 20-30 minutes working with foot and hand bicycle With an intensity equal to 65-80% of maximum heart rate depends on patients tolerance.
Category
Rehabilitation
2
Description
Intervention group: Yoga Combined Practice and Cardiac Rehabilitation, In the middle of a meeting, 8 weeks/ per weeks three tines about 1 hour (A yoga practice session and a routine rehearsal exercise session)
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Shahid Rajaee Heart Hospital
Full name of responsible person
Zahra Fathollahi
Street address
End of Hashemi Rafsanjani Highway
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 23921
Email
fakhari2013fatemeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Rajaee Hospital
Full name of responsible person
Sara Lotfian
Street address
End of Hashemi Rafsanjani High way
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 23921
Email
lotfiansara@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 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
Zahra Fathollahi
Position
Ph.D. Student, Azad University of Science and Research, Tehran, Iran
Latest degree
Master
Other areas of specialty/work
Sport Physiology of cardiovascular and respiration
Street address
Ferdous Boulivar
City
Tehran
Province
Tehran
Postal code
1481637453
Phone
+98 21 2217 4327
Email
mahsafathollahi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Fathollahi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Sport physiology of cardiovascular and inspiration
Street address
Ferdoys Boulivar
City
Tehran
Province
Tehran
Postal code
1481637453
Phone
+98 21 2217 4327
Email
mahsafathollahi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Fathollahi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Sport physiology of cardiovascular and inspiration
Street address
Ferdous Boulivar
City
Tehtan
Province
Tehran
Postal code
1481637453
Phone
+98 21 2217 4327
Email
mahsafathollahi@yahoo.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