Cognitive and Physical Optimization in Prevention of Postoperative Cognitive Deficit in Elderly With Lung Resection

NCT ID: NCT06339268

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2026-03-01

Brief Summary

Postoperative cognitive deficit and its connection with surgery and general anesthesia were first mentioned in the literature in 1955 by Bradford. Cognitive disorders in the postoperative period are postoperative delirium (POD) and postoperative cognitive dysfunction (POCD). POD is an acute dysfunction in cognition, which did not exist preoperatively. Attention deficit disorder is the main symptom of POD and refers to the inability to direct, focus, maintain, or shift attention. Memory impairment, disorientation, or perceptual disturbances may also be present. Cognitive capacity changes in POD patients develop and fluctuate in the first few days after surgery. Unlike POD, there is no formal definition for POCD. Based on data from the existing literature, it is defined as newly diagnosed cognitive deterioration that occurs after surgery. The diagnosis of POCD should be based on pre- and postoperative screening with appropriate psychometric tests. Risk factors for the development of POCD include those related to the surgical procedure, anesthesia, or the patient himself. Compared to less invasive and shorter operations, there is a higher risk of developing POCD after major, invasive, and long-term operations. Additional risk factors are intraoperative (intraoperative bleeding, perioperative transfusion treatment, hypotension) and postoperative complications (respiratory insufficiency, pneumonia, atelectasis, bronchospasm, bronchopleural fistula, and pulmonary edema). Presurgical optimization (Prehabilitation) is a widespread concept that aims to improve the general condition of the patient or optimize comorbidities before major surgery. Prehabilitation is primarily focused on improving physical ability and nutritional status, but it is developing in the direction of a multimodal approach that includes measures to reduce stress and anxiety. Psychological factors are increasingly recognized as an essential element of prehabilitation and are often added to prehabilitation programs.

Older patients, who meet the diagnostic criteria for frailty and are at risk of developing postoperative complications such as cognitive function disorders are increasingly

undergoing lung resection. These complications can affect the outcome and speed of postoperative recovery.

Detailed Description

After setting the indication for operative treatment, patients who meet the criteria for inclusion in the study, after signing the informed consent, will be randomized into two groups:

1. The first group (intervention) where the patient will receive preoperative cognitive stimulation and physical therapy for one month before surgical treatment.

2. The second group (control) where patients receive standard treatment. Randomization will be performed using computer randomization by doctors who do not participate in the testing and preoperative preparation of the patient.

Patients included in the first group will be subjected to psychological testing and preoperative training to receive tasks to improve cognitive functions. This technique, known as presurgical cognitive optimization, involves several standardized tests of cognitive stimulation through the cognitive training application (Cognifit) on a phone or tablet that patients use three times a week for 20 minutes for a month (from inclusion in the study to scheduled surgery). Also, after consultation with a physiatrist and testing for the presence of weakness syndrome as well as other tests related to the mobility and physical condition of patients, preoperative physical therapy (breathing exercises, walking, climbing stairs) will be carried out in this group of patients. Patients from this group, in addition to the exercise program they carry out for physical preparation before surgery, receive preoperative education on techniques and exercises that they will do immediately postoperatively in bed. Patients will keep a diary of preoperative activities that will be controlled by researchers.

Patients from the second group will be tested perioperatively with cognitive and weakness syndrome tests and other physiatry tests, but without cognitive intervention and physical therapy, they will be referred for surgery.

Conditions

Prehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention group

Patients included in the first group will be subjected to psychological testing and preoperative training with the aim of receiving tasks to improve cognitive functions. This technique involves several standardized tests of cognitive stimulation through the Cognifit application on a phone or tablet that patients use three times a week for 20 minutes for a month (from inclusion in the study to scheduled surgery). Also, after consultation with a physiatrist and testing for the presence of weakness syndrome as well as other tests related to the mobility and physical condition of patients, preoperative physical therapy (breathing exercises, walking, climbing stairs) will be carried out in this group of patients. Patients from this group, receive preoperative education on techniques and exercises that they will do immediately postoperatively in bed. Patients will keep a diary of preoperative activities that will be controlled by researchers.

Group Type: EXPERIMENTAL

Cognitive training, CogniFit App

Intervention Type: BEHAVIORAL

A patient will receive preoperative cognitive stimulation and physical therapy for one month before surgical treatment.

Control group

Patients from the second group will be tested perioperatively with cognitive and weakness syndrome tests and other physiatry tests, but without cognitive intervention and physical therapy, they will be referred for surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive training, CogniFit App

A patient will receive preoperative cognitive stimulation and physical therapy for one month before surgical treatment.

Intervention Type: BEHAVIORAL

Other Intervention Names

Physical therapy

Eligibility Criteria

Inclusion Criteria

• Older than 60 years
• Elective lung resection operations
• Patients who can use a phone or tablet
• Patients who agreed to participate in the study
• Clinical scale of weakness less than 6
• The American Society of Anesthesiologists (ASA) status I, II, III, IV

Exclusion Criteria

• Under 60 years of age
• Significant psychiatric comorbidity (schizophrenia, depression, alcoholism)
• Significant neurological comorbidity (dementia, cerebrovascular insult in the last 6 months, parkinsonism)
• Patient's refusal to participate in the study
• The inability of the patient to use a tablet or phone
• The American Society of Anesthesiologists (ASA) status V and VI
• Clinical weakness scale 6 and above

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Military Medical Academy, Belgrade, Serbia

OTHER

Sponsor Role: lead

Responsible Party

Associate Professor Vojislava Neskovic

Associated Professor of Anesthesia and Intensive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vojislava Neskovic, PhD

Role: PRINCIPAL_INVESTIGATOR

Military Medical Academy, Bulgaria

Locations

Military Medical Academy

Belgrade, , Serbia

Site Status: RECRUITING

Countries

Serbia

Central Contacts

Vojislava Neskovic, PhD

Role: CONTACT

vojkan43@gmail.com

+381641775320

Marija Markovic, MD

Role: CONTACT

markovicmarija@hotmail.com

+38162666653

Facility Contacts

Vojislava Neskovic, PhD

Role: primary

vojkan43@gmail.com

+381 64 1775 320

Marija Markovic, MD

Role: backup

markovicmarija@hotmail.com

+381 62 666653

References

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Reference Type: BACKGROUND

PMID: 31166241 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

MMABelgrade

Identifier Type: -

Identifier Source: org_study_id