Feasibility Study of Preoperative Cognitive Training in Cardiac Surgical Patients

Not Applicable

• Conditions: Postoperative Cognitive Dysfunction
• Interventions: Behavioral: Cog-Train Intervention

• Registration Number: NCT02053207
• Lead Sponsor: Papworth Hospital NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2014-01-20
• Study First Submitted QC: 2014-01-31
• Study First Posted: 2014-02-03
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-29
• Last Update Posted: 2017-12-02
• Study Start: 2018-01
• Primary Completion: 2018-11
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cog-Train Intervention	Cog-Train Intervention	-

Primary Outcome Measures

Name	Time	Method
Training performance gain	From 21 days prior to scheduled surgery to 1 day prior to scheduled surgery	Average increase in training task level achieved from first to last training day
Adherence to training regimen	From 21 days prior to scheduled surgery to 1 day prior to scheduled surgery	Mean number of training days completed according to instructions

Secondary Outcome Measures

Name	Time	Method
Side-effects	From 21 days prior to scheduled surgery to up to 14 days after surgery	Side effects and severity reported by patients and proportion of patients who reported side-effects
Recruitment and retention	10 weeks	Proportion of patients approached who can do the task and are willing to take part
Satisfaction and acceptability	At 1 day prior to scheduled surgery	Self report questionnaire

Trial Locations

Locations (1)

Papworth Hospital NHS Foundation Trust; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom