The efficacy of neurocognitive rehabilitation for patients undergoing coronary artery bypass graft surgery: from attention training to improving the quality of life
Introduction: Coronary artery disease is the most important disorder of the cardiovascular. Coronary artery bypass graft surgery (CABG) is a common and successful method of treatment of coronary artery disease. Brain injury occurs after cardiac surgery. A more common form of brain injury is cognitive deficits such as deterioration in memory, attention, (psycho)motor speed, and visuo-spatial ability. In fact, memory and attention deficits are frequent after (CABG) surgery. Furthermore, cognitive deficits are associated with decreased of quality of life. In broad terms, rehabilitation principally focuses on the enhancement of human functioning and quality of life. Cognitive rehabilitation includes remediation and training and is used to rehabilitate thinking skills (e.g., attention, memory) impaired.
Objectives: The aim of this study was to enhance the quality of life in patients undergoing CABG by using a computerized attention training program to improve cognitive deficits.
Method: In this semi experimental study, a randomized controlled trial with pre-test, post-test, and follow-up assessments along with placebo and control groups was conducted. In this clinical trial, 75 patients undergoing coronary artery bypass graft surgery selected by convenience sampling among patients who are undergoing rehabilitation at Tehran Heart Center. They randomly assigned to experimental, placebo and control groups. The participants complete assessments including the test of Continuous Performance, by the test of Flanker, the test of useful Field Of view, the test of Digit Span and a Quality of Life questionnaire (SF-36) at three time points: pre and post intervention as well as on-month follow-up.
General information
Acronym
CABG
IRCT registration information
IRCT registration number:IRCT2017022132704N1
Registration date:2017-10-28, 1396/08/06
Registration timing:registered_while_recruiting
Last update:
Update count:2
Registration date
2017-10-28, 1396/08/06
Registrant information
Name
Simin Sadat Ajtahed
Name of organization / entity
Shahidbeheshti medical university
Country
Iran (Islamic Republic of)
Phone
+98 31 5533 9289
Email address
s.ajtahed@gmail.com
Recruitment status
Recruitment complete
Funding source
This study was founded by personal financial sources by researcher and Cognitive Sciences and Technologies Council.
Expected recruitment start date
2017-10-17, 1396/07/25
Expected recruitment end date
2017-12-16, 1396/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of neurocognitive rehabilitation for patients undergoing coronary artery bypass graft surgery: from attention training to improving the quality of life
Public title
Cognitive rehabilitation for patients undergoing coronary artery bypass graft surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
1.Male or female outpatients.
2.Aged between 40 and 80.
3.Capable of perception of the research nature.
4.Able to give informed consent before any study is written.
5.Capable to speak in Persian with study personnel.
6.Able to read and write and work with computer.
7.Has a severe coronary heart disease (CHD) and has undergone a Coronary Artery Bypass Graft (CABG) Surgery.
8.Participation in concurrent standard routine rehabilitation during the trial.
Exclusion Criteria:
9.Has any clinical conditions that cause the usage of prescribed drugs that could have any effect on the Attention.
10.Dependency on alcohol or drugs.
11.Has any mental disorders that might interfere with the exact assessment or accuracy of treatment which is diagnosed and reported by official Tehran Heart Center experts.
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In the double blind study the participants in two groups and statistical analyst did not aware of study assignment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University
Street address
Enqelab Square-16 Azar Avenue
City
Tehran
Postal code
Approval date
2017-10-16, 1396/07/24
Ethics committee reference number
IR.ut.Rec.1395029
Health conditions studied
1
Description of health condition studied
Mild cognitive disorder
ICD-10 code
F06.7
ICD-10 code description
Mild cognitive disorder
Primary outcomes
1
Description
Selective attention
Timepoint
Before and after intervention, 1 month following intervention.
Method of measurement
Flanker test
2
Description
Sustained attention
Timepoint
Before and after intervention, 1 month following intervention.
Method of measurement
Continuous Performance test
3
Description
Divided attention
Timepoint
Before and after intervention, 1 month following intervention.
Method of measurement
Useful Field of View
4
Description
Working memory
Timepoint
Before and after intervention, 1 month following intervention.
Method of measurement
Digit Span test
Secondary outcomes
1
Description
Quality of life
Timepoint
Before and after intervention, 1 month following intervention.
Method of measurement
Quality of Life questionnaire (SF-36)
Intervention groups
1
Description
Experimental: cognitive intervention
This group of patients will be under intervention by computerized trainings of the Maghzineh Package to increase brain activation. This package has 24 exercise steps that the difficulty of exercises gradually increases in each step. These steps are carried out during the three months (two days a week) for each patient.
Category
Rehabilitation
2
Description
Sham comparator:
This group of patients will do some fake computerized trainings of the Maghzineh Package. This package has 24 exercise steps.These steps are carried out during the two months (three days a week) for each patient.
Category
Placebo
3
Description
control group:any intervention is not done on this group of patients
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center Hospital
Full name of responsible person
Dr. Soraya Etemadi
Street address
North Kargar Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Cognitive Sciences and Technologies Council
Full name of responsible person
Committee of Technology Research and Infrastructure
Street address
Argentine Square - St Alvand - No. 35
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?