Decreasing postoperative cognitive deficits after heart surgery: protocol for a randomized controlled trial on cognitive training

• Published in: Current controlled trials in cardiovascular medicine 2019-12, Vol.20 (1), p.733-733, Article 733
• Main Authors: Butz, Marius, El Shazly, Jasmin, Sammer, Gebhard, Tschernatsch, Marlene, Kastaun, Sabrina, Yenigün, Mesut, Braun, Tobias, Kaps, Manfred, Böning, Andreas, Puvogel, Ulrike, Bachmann, Georg, Mengden, Thomas, Schönburg, Markus, Gerriets, Tibo, Juenemann, Martin
• Format: Article
• Language: English
• Subjects: Brain; Cardiac patients; Cerebral ischemia; Clinical trials; Cognitive ability; Cognitive training; Delirium; Depression (Mood disorder); Elderly; Elderly patients; Embolization; Heart surgery; Hospitals; Ischemia; Magnetic resonance imaging; Neuropsychology; Older people; Patients; Postoperative cerebral microinfarcts; Postoperative cognitive deficits; Quality of life; Questionnaires; Rehabilitation; Stroke; Study Protocol
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-019-3799-0

The occurrence of postoperative cognitive deficits, especially after heart surgery, has been demonstrated in several studies. These deficits can clearly be noticed by the patients and by their close relatives in daily life. Furthermore, postoperative cognitive deficits can decrease quality of life in social functioning and earning capacity. The aim of this study is to investigate whether early postoperative cognitive training can reduce subjective and objective postoperative cognitive deficits. The proposed study is a multicenter, two-arm, randomized controlled trial involving 144 elderly patients undergoing elective heart-valve surgery with extracorporeal circulation. Patients will be assigned to either a training group or a control group. The intervention involves paper-and-pencil-based cognitive training, which is conducted for 36 min over a period of 18 days. The training starts about 1 week after surgery and is carried out during the hospitalized rehabilitation phase. The control group will not receive cognitive training or a placebo intervention. A detailed assessment of psychological functions and health-related quality of life prior to surgery at discharge from rehabilitation and 3 and 12 months after discharge will be performed. The primary outcome of this trial is the training effect on objective cognitive functions at discharge from rehabilitation. Secondary outcomes are the training effect on objective and subjective cognitive functions (3 and 12 months after discharge), depression, health-related quality of life, and the impact of perioperative cerebral ischemia on the training effect. Perioperative cerebral ischemia will be measured with postoperative magnetic resonance imaging including diffusion-weighted sequences. Should it be shown that our cognitive training can improve postoperative cognitive deficits and quality of life, one possibility could be to integrate this intervention into early rehabilitation. Furthermore, we hope that the investigation of perioperative ischemia by diffusion-weighted magnetic resonance imaging will improve our understanding of neurobiological factors influencing the course of postoperative cognitive plasticity. German Clinical Trials Register (DRKS), DRKS00015512. Retrospectively registered on 21 September 2018.