Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339268
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-11
Brief Title:
Cognitive and Physical Optimization in Prevention of Postoperative Cognitive Deficit in Elderly With Lung Resection
Sponsor:
Military Medical Academy Belgrade Serbia
Organization:
Military Medical Academy Belgrade Serbia
Study Overview
Official Title:
Effects of Preoperative Cognitive and Physical Optimization in the Prevention of Postoperative Cognitive Deficit in Elderly Patients With Lung Resection
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COGNITION
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None