The Effect and Mechanism of Computerized Cognition Training on the Incidence of Postoperative Cognitive Dysfunction After Cardiac Surgery

NCT05523258 | Unknown

• 1 other identifier: 2022-156
• Study Type: interventional
• Target: 174
• Locations: 0 countries
• Sites: N/A

Brief Summary

Whether enough time and high-quality cognitive training will reduce the incidence of postoperative cognitive dysfunction after cardiac surgery.

Conditions

Postoperative Cognitive Dysfunction(POCD)

Keywords

POCD; cardiac surgery; cognitive training

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative 7-day cognitive dysfunction

  The 7th day after operation

Secondary Outcomes (6)

• Postoperative 7-day changes of cognitive scores

  The 7th day after operation

• Postoperative 7-day changes of cortical network connectivity function

  The 7th day after operation

• Postoperative 7-day changes of sleep quality

  The 7th day after operation

• Incidence of postoperative delirium within 7 days

  Within 7 days after operation

• Incidence of postoperative 30-day cognitive dysfunction

  The 30th day after operation

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients in this group will receive computerized cognition training, including processing speed, attention, perception, long-term memory, working memory, calculation, executive control, reasoning and problem solving. The training program and its difficulty are constantly adjusted with the patients' training performance.

Behavioral: Computerized cognition training

Control group

SHAM COMPARATOR

Patients in this group will receive basic training based on tablet computer, and the subjects will receive five training tasks of processing speed and attention, which are fixed in difficulty and scheme. The training methods and intensity are similar to the intervention group.

Behavioral: Basic training based on tablet computer

Interventions

Computerized cognition training BEHAVIORAL

The researchers distribute tablet computers for the patients. The patients in this group receive cognitive function training under the guidance of a full-time cognitive function trainer. The training time is about 45-60 minutes every time, and the frequency is twice a day until the operation. After the operation, cognitive function training should be started as soon as possible when the patient meets the following conditions including Glasgow score ≥ 12, no mechanical ventilation and no sedative drugs. The training intensity is the same as that before operation, generally starting from the 2nd to 3rd day after operation and continuing to discharge or the 7th day after operation.

Intervention Group

Basic training based on tablet computer BEHAVIORAL

The researchers distribute the same tablet computer to the patients. The patients in this group receive basic training under the guidance of a full-time cognitive function trainer. The training duration is the same as that of the test group.

Control group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agree to participate in this study voluntarily;
• Age ≥ 60 years old；
• Patients who intend to accept elective coronary artery bypass grafting or valve replacement；
• The preoperative hospital stay is expected to be 5 days or more.

You may not qualify if:

• Definite diagnosis of senile dementia and Montreal Cognitive Assessment(MoCA) score ≤ 18;
• Patients with severe visual or hearing impairment who cannot complete the cognitive function assessment;
• Patients with limb movement disorder who cannot complete the cognitive function assessment;
• Patients with claustrophobia who cannot complete functional magnetic resonance imaging(fMRI) examination;
• The expected survival time is less than 1 month;
• Patients within 3 months or participating in other clinical trials.

Sponsors & Collaborators

• Mu Dong Liang: lead

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Dongliang Mu, Associate professor

CONTACT

13810702725; mudongliang@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy chief physician

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: August 31, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: September 2, 2022

Record last verified: 2022-08