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IRCT2017022132704N1 IRCT 2017-10-28 Cognitive Sciences and Technologies Council Efficacy of neurocognitive rehabilitation after CABG surgery in improving quality of life CABG; CCRT; RCR; QoL Efficacy of neurocognitive rehabilitation after coronary artery bypass graft surgery in improving quality of life: A randomized controlled trial 2017-10-17 anticipated 75 Complete https://irct.ir/trial/25408 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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), Blinding description: 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. N/A cognitive deficit. Intervention 1: 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. Intervention 2: 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. Intervention 3: Control Group:Patients in this group is going to receive RCR without any cognitive intervention for 2 months. Yes - There is a plan to make this available What will be shared: 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. When: data will be available before publishing results To whom: no limitation Conditions: publishing any result based on this research data is not allowed Where to obtain: 1. send request to s.ajtahed@gmail.com 2. search on OSF.io website How to obtain: data is accessible in the mentioned website. Comments:
public Simin Sadat Ajtahed
6 Cheshmeh Alley., 18 Sialk Alley., Amirkabir Ave
kashan Iran (Islamic Republic of) 8716900000 +98 31 5534 1046 s.ajtahed@gmail.com College of Farabi, University of Tehran scientific Hamed Ekhtiari
4th Phase of Pardis, Edalat square, Cognitive Science Blvd
Tehran Iran (Islamic Republic of) 3718117469 +98 21 7629 1130 H.ekhtiari@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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. 40 years 80 years Both 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. R41.84 Other specified cognitive deficit Rehabilitation Placebo N/A 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. 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. Control Group:Patients in this group is going to receive RCR without any cognitive intervention for 2 months. Selective attention. Timepoint: pre-intervention, post-intervention, 6-month follow-up. Method of measurement: Flanker test. Sustained attention. Timepoint: pre-intervention, post-intervention, 6-month follow-up. Method of measurement: Continuous Performance test. Divided attention. Timepoint: pre-intervention, post-intervention, 6-month follow-up. Method of measurement: Useful Field of View. Working memory. Timepoint: pre-intervention, post-intervention, 6-month follow-up. Method of measurement: Digit Span test (Forward and Backward ). Quality of life. Timepoint: pre-intervention, post-intervention, 6-month follow-up. Method of measurement: Quality of Life Short Form (SF-36) questionnaire. Tehran Heart Center Approved 2017-10-16 Ethics committee of Tehran University of Medical Sciences 16 Azar Ave., Enqelab Square- Tehran Tehran Iran (Islamic Republic of)