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

ABSTRACT: BACKGROUND: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. METHODS: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. DISCUSSION: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. TRIAL REGISTRATION:German Clinical Trials Register (DRKS), DRKS00015512. Retrospectively registered on 21 September 2018.

SUBMITTER: Butz M

PROVIDER: S-EPMC6916013 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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

Butz Marius M El Shazly Jasmin J Sammer Gebhard G Tschernatsch Marlene M Kastaun Sabrina S Yenigün Mesut M Braun Tobias T Kaps Manfred M Böning Andreas A Puvogel Ulrike U Bachmann Georg G Mengden Thomas T Schönburg Markus M Gerriets Tibo T Juenemann Martin M

Trials 20191216 1

<h4>Background</h4>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 c ...[more]

PMID: 31842959

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Project description:A majority of stroke survivors present with cognitive impairments. Attention disturbance, which leads to impaired concentration and overall reduced cognitive functions, is strongly associated with stroke. The clinical efficacy of acupuncture with Baihui (GV20) and Shenting (GV24) as well as computer-assisted cognitive training in stroke and post-stroke cognitive impairment have both been demonstrated in previous studies. To date, no systematic comparison of these exists and the potential beneficial effects of a combined application are yet to be examined. The main objective of this pilot study is to evaluate the effects of computer-assisted cognitive training compared to acupuncture on the outcomes of attention assessments. The second objective is to test the effects of a combined cognitive intervention that incorporates computer-assisted cognitive training and acupuncture (ACoTrain).An international multicentre, single-blinded, randomised controlled pilot trial will be conducted. In a 1:1:1 ratio, 60 inpatients with post-stroke cognitive dysfunction will be randomly allocated into either the acupuncture group, the computer-assisted cognitive training group, or the ACoTrain group in addition to their individual rehabilitation programme. The intervention period of this pilot trial will last 4 weeks (30 minutes per day, 5 days per week, Monday to Friday). The primary outcome is the test battery for attentional performance. The secondary outcomes include the Trail Making Test, Test des Deux Barrages, National Institute of Health Stroke Scale, and Modified Barthel Index for assessment of daily life competence, and the EuroQol Questionnaire for health-related quality of life.This trial mainly focuses on evaluating the effects of computer-assisted cognitive training compared to acupuncture on the outcomes of attention assessments. The results of this pilot trial are expected to provide new insights on how Eastern and Western medicine can complement one another and improve the treatment of cognitive impairments in early stroke rehabilitation. Including patients with different cultural backgrounds allows a more generalisable interpretation of the results but also poses risks of performance bias. Using standardised and well-described assessments, validated for each region, is pivotal to allow pooling of the data.Clinical Trails.gov ID: NCT02324959 (8 December 2014).

Project description:BACKGROUND:Postoperative delirium and postoperative cognitive dysfunction (POCD) are common after cardiac surgery and contribute to an increased risk of postoperative complications, longer length of stay, and increased hospital mortality. Cognitive training (CT) may be able to durably improve cognitive reserve in areas deficient in delirium and POCD and, therefore, may potentially reduce the risk of these conditions. We sought to determine the feasibility and potential efficacy of a perioperative CT program to reduce the incidence of postoperative delirium and POCD in older cardiac surgery patients. METHODS:Randomized controlled trial at a single tertiary care center. Participants included 45 older adults age 60-90 undergoing cardiac surgery at least 10 days from enrollment. Participants were randomly assigned in a 1:1 fashion to either perioperative CT via a mobile device or a usual care control. The primary outcome of feasibility was evaluated by enrollment patterns and adherence to protocol. Secondary outcomes of postoperative delirium and POCD were assessed using the Confusion Assessment Method and the Montreal Cognitive Assessment, respectively. Patient satisfaction was assessed via a postoperative survey. RESULTS:Sixty-five percent of eligible patients were enrolled. Median (interquartile range [IQR]) adherence (as a percentage of prescribed minutes played) was 39% (20%-68%), 6% (0%-37%), and 19% (0%-56%) for the preoperative, immediate postoperative, and postdischarge periods, respectively. Median (IQR) training times were 245 (136-536), 18 (0-40), and 122 (0-281) minutes for each period, respectively. The incidence of postoperative delirium (CT group 5/20 [25%] versus control 3/20 [15%]; P = .69) and POCD (CT group 53% versus control 37%; P = .33) was not significantly different between groups for either outcome in this limited sample. CT participants reported a high level of agreement (on a scale of 0-100) with statements that the program was easy to use (median [IQR], 87 [75-97]) and enjoyable (85 [79-91]). CT participants agreed significantly more than controls that their memory (median [IQR], 75 [54-82] vs 51 [49-54]; P = .01) and thinking ability (median [IQR], 78 [64-83] vs 50 [41-68]; P = .01) improved as a result of their participation in the study. CONCLUSIONS:A CT program designed for use in the preoperative period is an attractive target for future investigations of cognitive prehabilitation in older cardiac surgery patients. Changes in the functionality of the program and enrichment techniques may improve adherence in future trials. Further investigation is necessary to determine the potential efficacy of cognitive prehabilitation to reduce the risk of postoperative delirium and POCD.

Project description:BackgroundPostoperative cognitive dysfunction (POCD) refers to a neurological dysfunction after a major surgery and anesthesia. It is common in elderly patients and is characterized by impairment in consciousness, orientation, thinking, memory, and executive function after surgical anesthesia. However, at present, there is no definite preventive or treatable strategy for it. Previous animal experiments showed that giving probiotics to mice before operation can prevent POCD, but there is a lack of clinical evidence. This study aims to intervene with the intestinal flora imbalance using probiotics during the perioperative period to reduce the incidence of POCD in elderly patients after orthopedic surgery and to provide new ideas and methods for the clinical prevention and treatment of POCD.MethodsA multicenter, double-blind, placebo-controlled clinical trial will be performed to evaluate the efficacy of probiotics in elderly patients undergoing orthopedic surgery. Participants (n = 220) will receive probiotics (Peifeikang, Live Combined Bifidobacterium, 210 mg per capsule, twice a day, four capsules each time, which contains Bifidobacterium longum, Lactobacillus acidophilus and Streptococcus faecalis no less than 1.0 × 107 CFU viable bacteria respectively) or placebo from 1 day before surgery to 6 days after surgery. Neuropsychological tests will be performed 1 day before surgery and 1 week and 1 month after surgery. The main outcome of this study is the incidence of POCD 7 days after surgery. Our secondary objective is to assess the incidence of POCD 1 month after surgery; the cognitive status will be determined based on a telephone interview and will be evaluated via TICS-m; postoperative delirium will be assessed 7 days after surgery using the Confusion Assessment Method (CAM).DiscussionDiscovering the correlation between the intestinal microbiota and POCD is an important breakthrough. Based on the key role of the intestinal microbiota in other cognitive disorders, we hope that probiotics can reduce its incidence in elderly orthopedic patients.Trial registrationClinicalTrials.gov NCT04017403. Registered on August 15, 2019.

Project description:IntroductionPostoperative delirium (POD) and postoperative cognitive decline (POCD) can be observed after cardiosurgical interventions. Taken together, these postoperative neurocognitive disorders (PNCDs) contribute to increased morbidity and mortality. Preoperative risk factors of PNCD, such as decreased neuropsychometric performance or decreased cognitive daily activities, can be interpreted as reduced cognitive reserve. This study aims to build up cognitive reserves to protect against the development of PNCD through preoperative, home-based, cognitive training.MethodsThe planned research project is a monocentric, two-arm randomized controlled intervention study involving 100 patients undergoing elective cardiac surgery with extracorporeal circulation. Patients will be assigned to a training group or control group. The intervention involves a standardized, paper-and-pencil-based cognitive training that will be performed by the patients at home for ~40 min per day over a preoperative period of 2-3 weeks. The control group will receive neither cognitive training nor a placebo intervention. A detailed assessment of psychological functions will be performed ~2-3 weeks before the start of training, at the end of the training, during hospitalization, at discharge from the acute clinic, and 3 months after surgery. The primary objective of this study is to investigate the interventional effect of preoperative cognitive training on the incidence of POD during the stay in the acute clinic, the incidence of POCD at the time of discharge from the acute clinic, and 3 months after surgery. Secondary objectives are to determine the training effect on objective cognitive functions before the surgery and subjective cognitive functions, as well as health-related quality of life 3 months after surgery.DiscussionShould it become evident that the use of our cognitive training can both reduce the incidence of POCD and POD and improve health-related quality of life, this intervention may be integrated into a standardized prehabilitation program.

Project description:BackgroundRehabilitation strategies after abdominal surgery enhance recovery and improve outcome. A cornerstone of rehabilitation is respiratory physiotherapy with inspiratory muscle training to enhance pulmonary function. Pre-habilitation is the process of enhancing functional capacity before surgery in order to compensate for the stress of surgery and postoperative recovery. There is growing interest in deploying pre-habilitation interventions prior to surgery. The aim of this study is to assess the impact of preoperative inspiratory muscle training on postoperative overall morbidity. The question is, whether inspiratory muscle training prior to elective abdominal surgery reduces the number of postoperative complications and their severity grade.MethodsWe describe a prospective randomized-controlled single-centre trial in a tertiary referral centre. The primary outcome is the Comprehensive Complication Index (CCI) at 90 days after surgery. The CCI expresses morbidity on a continuous numeric scale from 0 (no complication) to 100 (death) by weighing all postoperative complications according to the Clavien-Dindo classification for their respective severity. In the intervention group, patients will be instructed by physiotherapists to perform inspiratory muscle training containing of 30 breaths twice a day for at least 2 weeks before surgery using Power®Breathe KHP2. Depending on the surgical schedule, training can be extended up to 6 weeks. In the control group, no preoperative inspiratory muscle training will be performed. After the operation, both groups receive the same physiotherapeutic support.DiscussionExisting data about preoperative inspiratory muscle training on postoperative complications are ambiguous and study protocols are often lacking a clear design and a clearly defined endpoint. Most studies consist of multi-stage concepts, comprehensively supervised and long-term interventions, whose implementation in clinical practice is hardly possible. There is a clear need for randomized-controlled studies with a simple protocol that can be easily transferred into clinical practice. This study examines the effortless adjustment of the common respiratory physiotherapy from currently postoperative to preoperative. The external measurement by the device eliminates the diary listing of patients' performances and allows the exercise adherence and thus the effect to be objectively recorded.Trial registrationClinicalTrials.gov NCT04558151 . Registered on September 15, 2020.

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

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

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