Clinical trial NCT02053207: Feasibility Study of Preoperative Cognitive Training in Cardiac Surgical Patients
Official title: The Cog-Train Feasibility Study: a Single-arm Trial Investigating the Feasibility of a Preoperative Cognitive Training Intervention (Cog-Train) in Cardiac Surgical Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Cognitive Dysfunction
Keywords: Cognitive training
Brain training
Plasticity-based training
Cardiac surgery
Preoperative
Cognitive function
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Medical Research Council Cognition and Brain Sciences Unit
First posted: 2014-02-03
Enrollment: 10
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the feasibility of administering a 20-day preoperative cognitive training intervention (Cog-Train) to a widely inclusive sample of cardiac surgical patients.

Detailed description: Cognitive outcomes remain poor after cardiac surgery. Data from the field of cognitive neuroscience suggests that cognitive training, which harnesses the brain's adaptive plasticity to improve, maintain, or restore function in a target area, can be used to strengthen brain resilience and improve cognitive outcomes following challenge. While its effectiveness has been demonstrated in older adults as well as in other (nonsurgical) patient populations, no training intervention like this has ever before been used in any surgical patient in the preoperative period. The purpose of this study is to evaluate the feasibility of administering a 20-day cognitive training intervention (Cog-Train) to a widely inclusive sample of cardiac surgical patients before their surgery. Data obtained will be used to design a full-scale randomised controlled trial (RCT) on Cog-Train's effectiveness in improving postoperative cognitive outcomes.

Eligibility criteria: Inclusion Criteria:

* Scheduled for elective cardiac surgery with cardiopulmonary bypass at Papworth Hospital
* Aged 60+ years

Exclusion Criteria:

* Surgery scheduled for sooner than 21 days
* 'Off-pump' surgery being considered
* Inability to obtain informed consent
* Sensory or motor impairments impeding use of task
* Communication barriers impeding administration of study procedures
* Inability to demonstrate understanding of task and/or study procedures
* Inability to make time commitment

Primary outcomes:
measure: Training performance gain
timeFrame: From 21 days prior to scheduled surgery to 1 day prior to scheduled surgery
measure: Adherence to training regimen
timeFrame: From 21 days prior to scheduled surgery to 1 day prior to scheduled surgery
Secondary outcomes:
measure: Recruitment and retention
timeFrame: 10 weeks
measure: Satisfaction and acceptability
timeFrame: At 1 day prior to scheduled surgery
measure: Side-effects
timeFrame: From 21 days prior to scheduled surgery to up to 14 days after surgery
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS Foundation Trust
state: Cambridgeshire
Study officials:
affiliation: Papworth Hospital NHS Foundation Trust
name: Alain Vuylsteke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schweizer S, Hampshire A, Dalgleish T. Extending brain-training to the affective domain: increasing cognitive and affective executive control through emotional working memory training. PLoS One. 2011;6(9):e24372. doi: 10.1371/journal.pone.0024372. Epub 2011 Sep 19.