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Feasibility Study of Preoperative Cognitive Training in Cardiac Surgical Patients

NCT ID: NCT02053207

Last Updated: 2017-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Postoperative Cognitive Dysfunction

Keywords

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Cognitive training Brain training Plasticity-based training Cardiac surgery Preoperative Cognitive function

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cog-Train Intervention

Group Type EXPERIMENTAL

Cog-Train Intervention

Intervention Type BEHAVIORAL

Twenty-one days prior to surgery, patients will begin self-administering the intervention using an iPad tablet. This intervention will consist with daily sessions of at least 20 minutes of the Cog-Train task (the task and regimen used to obtain robust effects in previous studies by members of our group). Cog-Train is an n-back task - an adaptive working memory computer game that extends players' working memory capacity by getting progressively more difficult as the player's performance increases.

Interventions

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Cog-Train Intervention

Twenty-one days prior to surgery, patients will begin self-administering the intervention using an iPad tablet. This intervention will consist with daily sessions of at least 20 minutes of the Cog-Train task (the task and regimen used to obtain robust effects in previous studies by members of our group). Cog-Train is an n-back task - an adaptive working memory computer game that extends players' working memory capacity by getting progressively more difficult as the player's performance increases.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Research Council Cognition and Brain Sciences Unit

OTHER_GOV

Sponsor Role collaborator

Papworth Hospital NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alain Vuylsteke, MD

Role: PRINCIPAL_INVESTIGATOR

Papworth Hospital NHS Foundation Trust

Locations

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Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Kimberly Giraud, PhD

Role: CONTACT

Phone: 01480 830541

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 21949712 (View on PubMed)

Other Identifiers

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P01907

Identifier Type: -

Identifier Source: org_study_id