Clinical trial NCT06339268: Cognitive and Physical Optimization in Prevention of Postoperative Cognitive Deficit in Elderly With Lung Resection
Official title: Effects of Preoperative Cognitive and Physical Optimization in the Prevention of Postoperative Cognitive Deficit in Elderly Patients With Lung Resection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prehabilitation
Lead sponsor: Military Medical Academy, Belgrade, Serbia
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Postoperative cognitive dysfunction
timeFrame: From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day
measure: Perioperative depression and anxiety
timeFrame: From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day
measure: Postoperative delirium
timeFrame: First postoperative day
measure: Functional status and postoperative recovery
timeFrame: From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day
measure: Functional status and postoperative recovery
timeFrame: From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day
measure: Postoperative recovery
timeFrame: From 1st til 5th postoperative day
measure: Functional status and postoperative recovery
timeFrame: From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day
Secondary outcomes:
measure: Overall outcome: Complication rate
timeFrame: From surgery until 30th postoperative day
measure: Overall outcome: Morbidity
timeFrame: From surgery until 30th postoperative day
measure: Overall outcome: Mortality
timeFrame: From surgery until 30th postoperative day
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Military Medical Academy
Study officials:
affiliation: Military Medical Academy, Bulgaria
name: Vojislava Neskovic, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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