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

April 21, 2025 updated by: Associate Professor Vojislava Neskovic, Military Medical Academy, Belgrade, Serbia

Effects of Preoperative Cognitive and Physical Optimization in the Prevention of Postoperative Cognitive Deficit in Elderly Patients With Lung Resection

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: Cognitive training, CogniFit App
A patient will receive preoperative cognitive stimulation and physical therapy for one month before surgical treatment.
Other Names:
  • Physical therapy
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative cognitive dysfunction
Time Frame: From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day

Incidence of newly diagnosed or worsening of the existing postoperative cognitive decline assessed by change in score of MMSE - Mini-Mental State Examination (an 11-question measure that tests five areas of cognitive function: orientation, registration, attention, and calculation, recall, and language). On a scale from 0-30 points:

≥ 25 points normal cognitive function 19-24 points minor cognitive dysfunction 10-18 points medium cognitive dysfunction

≤ 9 points major cognitive dysfunction In this study change of 3 or more points in MMSE between two tests ( pre and postoperative) or between individual participants will be marked as significant
From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day
Perioperative depression and anxiety
Time Frame: From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day

Perioperative assessment of depression, anxiety, and stress: DAS - depression and anxiety assessment scale (42-item self-report scale measures the negative emotional states of depression, anxiety, and stress)

Scoring Guide DASS (42) Scoring Depression Anxiety Stress Normal 0-9 0-7 0-14 Mild 10-13 8-9 15-18 Moderate 14-20 10-14 19-25 Severe 21-27 15-19 26-33 Extremely Severe 28+ 20+ 34+

Results are assessed between the intervention group and control
From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day
Postoperative delirium
Time Frame: First postoperative day

Incidence of newly diagnosed postoperative delirium: CAM-ICU (Confusion Assessment Method for the ICU) using CAM-ICU Flowsheet:

Step 1. Acute Change or Fluctuating Course of Mental Status: yes (delirium positive) or no (CAM-ICU negative) Step 2. Inattention: 0 - 2 errors (CAM-ICU negative) or > 2 errors go to next step Step 3. Altered Level of Consciousness (the Richmond Agitation-Sedation Scale - RASS): from -5 (unarousable - no response to voice or physical stimulation) to +4 (combative). Anything other than 0 (alert and calm) goes to the next step.

Step 4. Disorganized thinking: 0-1 errors (not delirious) or > 1 error (delirious) Feature 1 plus 2 and either 3 or 4 present = CAM-ICU positive
First postoperative day
Functional status and postoperative recovery
Time Frame: From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day

Assessment of the functional status and speed of recovery - Clinical frailty scale: from 1 (very fit) to 9 (terminally Ill). Only patients marked as less than 6 are included in the study.

Any change in the assessment score is marked as significant
From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day
Functional status and postoperative recovery
Time Frame: From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day

Assessment of the functional status and speed of recovery - the New mobility score is a composite score of the patient's ability to perform:

  • indoor walking,
  • outdoor walking
  • shopping

providing a score between zero and three (0: not at all, 1: with help from another person, 2: with an aid, 3: no difficulty) for each function. The total score can be from 0 to 9, with 9 indicating a high functional level.
From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day
Postoperative recovery
Time Frame: From 1st til 5th postoperative day
Assessment of the speed of recovery - A test of functional recovery: 10 items for assessing basic activities by a six-level ordinal scale 0 (activity not achieved) -5 (fully independent and secure). Total scores can range from 0 to 50 (from inability to perform any activity to complete independence.) Speed of recovery will be assessed with a comparison of the scores during the first 5 postoperative days.
From 1st til 5th postoperative day
Functional status and postoperative recovery
Time Frame: From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day

Assessment of the functional status and speed of recovery Timed up and go test is performed by measuring the time for the following sequence of actions:

  1. Stand up from the chair.
  2. Walk to the line on the floor at a normal pace.
  3. Turn.
  4. Walk back to the chair at a normal pace.
  5. Sit down again.

Mobility is assessed based on time to complete the test:

< 10 seconds = normal < 20 seconds = good mobility; can walk outside alone; does not require a walking aid < 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid
From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall outcome: Complication rate
Time Frame: From surgery until 30th postoperative day

Complication rate will be presented as % of patients within the groups who develop:

  • Respiratory failure
  • Pneumonia
  • Atelectasis
  • Bronchospasm
  • Bronchopleural fistula
  • Air leak
  • Pulmonary edema
From surgery until 30th postoperative day
Overall outcome: Morbidity
Time Frame: From surgery until 30th postoperative day
Morbidity will be presented as % of patients within the groups who develop any kind of complication or illness postoperatively during the period of follow-up
From surgery until 30th postoperative day
Overall outcome: Mortality
Time Frame: From surgery until 30th postoperative day
Mortality will be presented as overall and % of deaths in the study population and both groups
From surgery until 30th postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Military Medical Academy, Belgrade, Serbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vojislava Neskovic, PhD, Military Medical Academy, Bulgaria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MMABelgrade

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data that are collected during the trial, after identification will be shared.

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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