Protocol summary
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Study aim
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The aim of this study is to assess the efficacy of Computerized Cognitive Rehabilitation Therapy (CCRT) as a supplementary treatment to Routine Cardiac Rehabilitation (RCR) after Coronary Artery Bypass Graft (CABG) surgery in improving Quality of Life (QoL).
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Design
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The study is a randomized, single blind and parallel-group controlled trial with CCRT, active control and control groups in which 75 outpatients are going to be randomized by enrollment date.
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Settings and conduct
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This study will be carried out in Tehran Heart Center. At the beginning, general assessment of patients (demographic and clinical data) will be recorded and subjects complete the QoL questionnaire (SF-36), then baseline assessment of cognitive functions will be done.The computerized cognitive training program applied in this study is Maghzineh®.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Male or female outpatients. Aged between 40 and 80. Capable of perception of the research nature. Able to give informed consent before any study is written. Capable to speak in Persian with study personnel. Able to read and write and work with computer. Participation in concurrent standard routine rehabilitation during the trial; Exclusion Criteria:Dependency on alcohol or drugs. Has any mental disorders that might interfere with the exact assessment or accuracy of treatment. Has any clinical conditions that cause the usage of prescribed drugs that could have any effect on the Attention.
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Intervention groups
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Patients in CCRT group will receive CCRT plus RCR. CCRT is going to be conducted individually in 24, 20-minute sessions within 8 weeks; Patients in the active control group will receive a sham version of CCRT plus RCR; Patients in the control group will receive RCR without any cognitive intervention for 2 months.
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Main outcome variables
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cognitive functions; Quality o Life
General information
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Reason for update
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Acronym
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CABG; CCRT; RCR; QoL
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IRCT registration information
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IRCT registration number:
IRCT2017022132704N1
Registration date:
2017-10-28, 1396/08/06
Registration timing:
registered_while_recruiting
Last update:
2018-11-23, 1397/09/02
Update count:
2
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Registration date
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2017-10-28, 1396/08/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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This study was founded by personal financial sources by researcher and Cognitive Sciences and Technologies Council.
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Expected recruitment start date
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2017-10-17, 1396/07/25
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Expected recruitment end date
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2018-01-15, 1396/10/25
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Actual recruitment start date
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2017-10-21, 1396/07/29
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Actual recruitment end date
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2018-01-20, 1396/10/30
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Trial completion date
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2018-09-15, 1397/06/24
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Scientific title
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Efficacy of neurocognitive rehabilitation after coronary artery bypass graft surgery in improving quality of life: A randomized controlled trial
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Public title
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Efficacy of neurocognitive rehabilitation after CABG surgery in improving quality of life
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Male or female outpatients.
Aged between 40 and 80.
Capable of perception of the research nature.
Able to give informed consent before any study is written.
Capable to speak in Persian with study personnel.
Able to read and write and work with computer.
Participation in concurrent standard routine rehabilitation during the trial.
Exclusion criteria:
Dependency on alcohol or drugs.
Has any mental disorders that might interfere with the exact assessment or accuracy of treatment.
Has any clinical conditions that cause the usage of prescribed drugs that could have any effect on the Attention.
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Age
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From 40 years old to 80 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
75
Actual sample size reached:
72
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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This is a randomized controlled trial with pre-, post- and follow-up assessments that is going to be conducted in CCRT, active control and control groups. 75 outpatients will be selected by convenience sampling among patients after CABG surgery. Randomization will be carried out by the patients enrollment date in Tehran Heart Center(first month= CCRT group, second month= active control group, third month= control group).
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The randomization of volunteer patients for participation in the study will be carried out by the patients enrollment date in Tehran Heart Center (first month= CCRT group, second month= active control group, third month= control group).
clinical personnel are not aware of randomization according to enrollment date.
Scores of computerized training are going to be recorded online and after the accomplishment of intervention, the data will be received from related corporation.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-10-16, 1396/07/24
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Ethics committee reference number
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IR.ut.Rec.1395029
Health conditions studied
1
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Description of health condition studied
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cognitive deficit
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ICD-10 code
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R41.84
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ICD-10 code description
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Other specified cognitive deficit
Primary outcomes
1
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Description
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Selective attention
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Timepoint
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pre-intervention, post-intervention, 6-month follow-up.
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Method of measurement
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Flanker test
2
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Description
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Sustained attention
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Timepoint
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pre-intervention, post-intervention, 6-month follow-up.
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Method of measurement
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Continuous Performance test
3
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Description
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Divided attention
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Timepoint
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pre-intervention, post-intervention, 6-month follow-up.
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Method of measurement
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Useful Field of View
4
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Description
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Working memory
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Timepoint
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pre-intervention, post-intervention, 6-month follow-up.
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Method of measurement
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Digit Span test (Forward and Backward )
Secondary outcomes
1
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Description
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Quality of life
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Timepoint
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pre-intervention, post-intervention, 6-month follow-up.
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Method of measurement
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Quality of Life Short Form (SF-36) questionnaire
Intervention groups
1
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Description
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CCRT Group:This group of patients is going to receive CCRT plus RCR to activate different cognitive functions including attention, working memory and inhibition.The computerized cognitive training program applied in this study is Maghzineh®. This package has 24 exercise steps that the difficulty of exercises gradually increases according to the subject's performance. CCRT will be conducted individually in 24, 20-minute sessions within 8 weeks.
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Category
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Rehabilitation
2
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Description
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Active cotrol Group: This group patients is going to receive a sham version of CCRT plus RCR. The sham version involves the same training program without adaptivity and the difficulty level remains constant across the entire intervention. Sham version of CCRT will be conducted individually in 24, 20-minute sessions within 8 weeks.
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Category
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Placebo
3
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Description
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Control Group:Patients in this group is going to receive RCR without any cognitive intervention for 2 months.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Tehran Heart Center
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Proportion provided by this source
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1
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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all data can be shared after removing the possibility of knowing individuals including:
1. demographic data; 2. data of cognitive performance and quality of life in pre-, post- and follow-up assessments.
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When the data will become available and for how long
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data will be available before publishing results
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To whom data/document is available
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no limitation
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Under which criteria data/document could be used
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publishing any result based on this research data is not allowed
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From where data/document is obtainable
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1. send request to s.ajtahed@gmail.com
2. search on OSF.io website
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What processes are involved for a request to access data/document
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data is accessible in the mentioned website.
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Comments
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