The Effect of Eight Weeks Aerobic Exercise and Sertraline Intake on Neurotrophic Factors, Inflammatory, Depressive, and Quality of Life of Patients after Coronary Artery Bypass Graft Surgery
Determining the effects 8 of aerobic exercise and sertraline on neurotrophic, inflammatory, depressive and quality of life factors among the patients after coronary artery bypass graft surgery
The research method is quasi-experimental with pretest-post test design.The statistical population of this study consisted of men with the age of40-60 years with coronary artery bypass graft referring to Fatemeh Zahra Hospital in Sari.The Sampling method was available.The groups were blinded by the participants in terms of participants and coded by the researcher. Finally, study hypotheses in the study groups were examined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patients who underwent CABG surgery for the first time.They ranged from 40 to 60 years in age. At least 2 to 6 months have elapsed since CABG surgery. Anxiety and depression scores are based on the HADS score of 8 or higher
Exclusion criteria: Having complicated ventricular arrhythmia, having a heart failure, having regular exercise history
Intervention groups
1- Aerobic training group, 2-Drug Intervention Group, 3-Drug-exercise group (Combined), 4- Control group
The intervention time for all 4 groups were 8 weeks.
The drug group and the drug-exercise group took 25 to 50 mg once daily for 8 weeks.
No intervention was performed on the control group and routine care was taken and placebo was given to them.
Main outcome variables
Health practitioners and physicians
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191125045496N1
Registration date:2020-04-17, 1399/01/29
Registration timing:retrospective
Last update:2020-04-17, 1399/01/29
Update count:0
Registration date
2020-04-17, 1399/01/29
Registrant information
Name
Mostafa Behzad Khamslo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3310 9230
Email address
mostafabehzadkh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-11, 1398/05/20
Expected recruitment end date
2019-10-12, 1398/07/20
Actual recruitment start date
2019-08-11, 1398/05/20
Actual recruitment end date
2019-11-16, 1398/08/25
Trial completion date
2020-01-30, 1398/11/10
Scientific title
The Effect of Eight Weeks Aerobic Exercise and Sertraline Intake on Neurotrophic Factors, Inflammatory, Depressive, and Quality of Life of Patients after Coronary Artery Bypass Graft Surgery
Public title
The effect of Aerobic Exercise with Sertraline On Patients after Coronary Artery Bypass Graft Surgery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
The patients who underwent CABG surgery for the first time.
They will range from 40 to 60 years in age.
At least 2 to 6 months have elapsed since CABG surgery.
Anxiety and depression scores based on the HADS score of 8 or higher.
Exclusion criteria:
Having unstable angina pectoris and complicated ventricular arrhythmias
Not having a heart failure
Having regular exercise history
Patient history of taking sertraline, or other antidepressant and anxiety medications
Age
From 40 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Actual sample size reached:
48
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Blind is done by the supervisor. Participants and researchers were blinded in this study.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
No. 3, Mahyar St., Maulam Blvd., Sari Town
City
Sari
Province
Mazandaran
Postal code
4817875816
Approval date
2019-12-18, 1398/09/27
Ethics committee reference number
IR.MAZUMS.REC.1398.1167
Health conditions studied
1
Description of health condition studied
Patients after coronary artery bypass surgery(CABG)
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
Depression and anxiety
Timepoint
At baseline (before intervention) and 8 weeks after intervention
Method of measurement
Hospital Anxiety and Depression Scale (HADS)
2
Description
Quality of Life
Timepoint
At baseline (before intervention) and 8 weeks after intervention
Method of measurement
Short Form Quality of Life Questionnaire (SF-36)
3
Description
Brain-derived neurotrophic factor
Timepoint
At baseline (before intervention) and 8 weeks after intervention
Method of measurement
By Eliza's research kit
4
Description
Interleukin-6
Timepoint
At baseline (before intervention) and 8 weeks after intervention
Method of measurement
By Eliza's research kit
5
Description
C-Reactive Protein
Timepoint
At baseline (before intervention) and 8 weeks after intervention
Method of measurement
By Eliza's research kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1: Aerobic training group:Aerobic exercise for eight weeks (three sessions per week) consisted of 50-70% of maximal heart rate training for 20 to 40 minutes on the treadmill, under the control of a physician.
Category
Treatment - Other
2
Description
Intervention group:Drug Intervention Group: In addition to the usual care of the intervention groups (training-drug group and the drug group), the drug was administered by Hakim Darou Co, 25- 50 mg once daily for 8 weeks, according to the order of the treating physician.
Category
Treatment - Other
3
Description
Intervention group:Drug-exercise group (Combined):The group combined aerobic exercise with the mentioned intensity for 8 weeks as well as sertraline At a rate of 25- 50 mg once daily for 8 weeks.
Category
Treatment - Other
4
Description
Control group: No intervention was performed on the control group and routine care was taken and placebo was given.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatima Zahra Sari Heart Hospital
Full name of responsible person
Mstafa Behzad Khamslo
Street address
Fatima Zahra Heart Hospital., Army Boulevard., Sari Town
City
Sari
Province
Mazandaran
Postal code
4817875816
Phone
+98 11 3336 1700
Email
mostafabehzadkh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Seyed Hamzeh Hosseini
Street address
Imam Khomeini Hospital., Amir Mazandaran St., Sari Town
City
Sari
Province
Mazandaran
Postal code
4817875816
Phone
+98 11 3336 1700
Email
hosseinish20@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
10
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
Mazandaran University of Medical Sciences
Full name of responsible person
Seyed Hamzeh Hosseini
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Imam Khomeini Hospital., Amir Mazandaran St., Sari Town
City
Sari
Province
Mazandaran
Postal code
4817875816
Phone
+98 11 3310 9231
Email
hosseinish20@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mostafa Behzad Khamslo
Position
Teaching
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
No. 3, Mahyar St., Maulam Blvd., Sari Town
City
Sari
Province
Mazandaran
Postal code
4817875816
Phone
+98 11 3310 9230
Fax
Email
mostafabehzadkh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mostafa Behzad Khamslo
Position
Teaching
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
No. 3, Mahyar St., Maulam Blvd., Sari Town
City
Sari
Province
Mazandaran
Postal code
4817875816
Phone
+98 11 3310 9230
Fax
Email
mostafabehzadkh@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
Informed Consent Form
No - There is not 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