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

Prehabilitation Clinical Trial

— COGNITION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06339268
• Other study ID #: MMABelgrade
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: March 2024
• Source: Military Medical Academy, Belgrade, Serbia
• Contact: Vojislava Neskovic, PhD
• Phone: +381641775320
• Email: vojkan43[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 1, 2026
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Dysfunction
• Prehabilitation

Intervention

Behavioral:
• Cognitive training, CogniFit App
A patient will receive preoperative cognitive stimulation and physical therapy for one month before surgical treatment.

Locations

Country	Name	City	State
Serbia	Military Medical Academy	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
Military Medical Academy, Belgrade, Serbia

Country where clinical trial is conducted

Serbia, 

References & Publications (9)

BEDFORD PD. Adverse cerebral effects of anaesthesia on old people. Lancet. 1955 Aug 6;269(6884):259-63. doi: 10.1016/s0140-6736(55)92689-1. No abstract available. — View Citation

Carli F. Prehabilitation for the Anesthesiologist. Anesthesiology. 2020 Sep;133(3):645-652. doi: 10.1097/ALN.0000000000003331. No abstract available. — View Citation

Daiello LA, Racine AM, Yun Gou R, Marcantonio ER, Xie Z, Kunze LJ, Vlassakov KV, Inouye SK, Jones RN, Alsop D, Travison T, Arnold S, Cooper Z, Dickerson B, Fong T, Metzger E, Pascual-Leone A, Schmitt EM, Shafi M, Cavallari M, Dai W, Dillon ST, McElhaney J, Guttmann C, Hshieh T, Kuchel G, Libermann T, Ngo L, Press D, Saczynski J, Vasunilashorn S, O'Connor M, Kimchi E, Strauss J, Wong B, Belkin M, Ayres D, Callery M, Pomposelli F, Wright J, Schermerhorn M, Abrantes T, Albuquerque A, Bertrand S, Brown A, Callahan A, D'Aquila M, Dowal S, Fox M, Gallagher J, Anna Gersten R, Hodara A, Helfand B, Inloes J, Kettell J, Kuczmarska A, Nee J, Nemeth E, Ochsner L, Palihnich K, Parisi K, Puelle M, Rastegar S, Vella M, Xu G, Bryan M, Guess J, Enghorn D, Gross A, Gou Y, Habtemariam D, Isaza I, Kosar C, Rockett C, Tommet D, Gruen T, Ross M, Tasker K, Gee J, Kolanowski A, Pisani M, de Rooij S, Rogers S, Studenski S, Stern Y, Whittemore A, Gottlieb G, Orav J, Sperling R; SAGES Study Group*. Postoperative Delirium and Postoperative Cognitive Dysfunction: Overlap and Divergence. Anesthesiology. 2019 Sep;131(3):477-491. doi: 10.1097/ALN.0000000000002729. — View Citation

Durrand J, Singh SJ, Danjoux G. Prehabilitation. Clin Med (Lond). 2019 Nov;19(6):458-464. doi: 10.7861/clinmed.2019-0257. — View Citation

Gracie TJ, Caufield-Noll C, Wang NY, Sieber FE. The Association of Preoperative Frailty and Postoperative Delirium: A Meta-analysis. Anesth Analg. 2021 Aug 1;133(2):314-323. doi: 10.1213/ANE.0000000000005609. — View Citation

Needham MJ, Webb CE, Bryden DC. Postoperative cognitive dysfunction and dementia: what we need to know and do. Br J Anaesth. 2017 Dec 1;119(suppl_1):i115-i125. doi: 10.1093/bja/aex354. — View Citation

Strom C, Rasmussen LS, Sieber FE. Should general anaesthesia be avoided in the elderly? Anaesthesia. 2014 Jan;69 Suppl 1(Suppl 1):35-44. doi: 10.1111/anae.12493. — View Citation

Sugimoto T, Arai H, Sakurai T. An update on cognitive frailty: Its definition, impact, associated factors and underlying mechanisms, and interventions. Geriatr Gerontol Int. 2022 Feb;22(2):99-109. doi: 10.1111/ggi.14322. Epub 2021 Dec 9. — View Citation

Wang W, Wang Y, Wu H, Lei L, Xu S, Shen X, Guo X, Shen R, Xia X, Liu Y, Wang F. Postoperative cognitive dysfunction: current developments in mechanism and prevention. Med Sci Monit. 2014 Oct 12;20:1908-12. doi: 10.12659/MSM.892485. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative cognitive dysfunction	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
Primary	Perioperative depression and anxiety	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
Primary	Postoperative delirium	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
Primary	Functional status and postoperative recovery	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
Primary	Functional status and postoperative recovery	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
Primary	Postoperative recovery	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
Primary	Functional status and postoperative recovery	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: Stand up from the chair.; Walk to the line on the floor at a normal pace.; Turn.; Walk back to the chair at a normal pace.; 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	Overall outcome: Complication rate	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
Secondary	Overall outcome: Morbidity	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
Secondary	Overall outcome: Mortality	Mortality will be presented as overall and % of deaths in the study population and both groups	From surgery until 30th postoperative day