PrehabilitationCOGNITIONNCT06339268
Cognitive and Physical Optimization in Prevention of Postoperative Cognitive Deficit in Elderly With Lung Resection
A study testing Cognitive training, CogniFit App in people with Prehabilitation, run by Military Medical Academy, Belgrade, Serbia at 1 site in Serbia.
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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Prehabilitation
- What is being tested?
- Cognitive training, CogniFit App
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Nov 2023to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Serbia1 site, 1 recruiting
- Recruiting
Military Medical Academy
Belgrade, 11000
Vojislava Neskovic, PhD, +381 64 1775 320, vojkan43@gmail.com
Marija Markovic, MD, +381 62 666653, markovicmarija@hotmail.com
About this study
Official title: 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.
Read the 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:
- The first group (intervention) where the patient will receive preoperative cognitive stimulation and physical therapy for one month before surgical treatment.
- 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
- Being tested
- Cognitive training, CogniFit App
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive training, CogniFit AppBehavioural
Also called Physical therapy
A patient will receive preoperative cognitive stimulation and physical therapy for one month before surgical treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Behavioral: Cognitive training, CogniFit App |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day
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
Measured: From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day
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
Measured: First postoperative day
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
Measured: From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day
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.
Measured: From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day
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.
Measured: From 1st til 5th postoperative day
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
Measured: From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day
Secondary outcomes (3)
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
Measured: From surgery until 30th postoperative day
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
Measured: From surgery until 30th postoperative day
Overall outcome: Mortality
Mortality will be presented as overall and % of deaths in the study population and both groups
Measured: From surgery until 30th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Nov 2023
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PrehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military Medical Academy, Belgrade, Serbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Associate Professor Vojislava Neskovic, Military Medical Academy, Belgrade, Serbia
- Investigators
- Vojislava Neskovic, PhD, Principal investigator, Military Medical Academy, Bulgaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339268
- Sponsor's protocol ID
- MMABelgrade
- Acronym
- COGNITION
- Status last verified
- Apr 2025
- First submitted
- 11 Mar 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data that are collected during the trial, after identification will be shared.
Publications
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.
PubMed 13243706Strom 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.
PubMed 24303859Needham 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.
PubMed 29161395Carli F. Prehabilitation for the Anesthesiologist. Anesthesiology. 2020 Sep;133(3):645-652. doi: 10.1097/ALN.0000000000003331. No abstract available.
PubMed 32358253Daiello 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.
PubMed 31166241Wang 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.
PubMed 25306127Sugimoto 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.
PubMed 34882939Gracie 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.
PubMed 34257192Durrand J, Singh SJ, Danjoux G. Prehabilitation. Clin Med (Lond). 2019 Nov;19(6):458-464. doi: 10.7861/clinmed.2019-0257.
PubMed 31732585Neskovic V, Markovic M, Maric N, Kostic S. Effect of preoperative cognitive and physical optimization in the prevention of postoperative cognitive deficit in elderly patients with lung resection - cognition trial. Trials. 2025 Dec 12;27(1):44. doi: 10.1186/s13063-025-08894-8.
PubMed 41387902
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Cognitive and Physical Optimization in the Prevention of Postoperative Cognitive Deficit in Elderly Patients With Lung Resection
- ClinicalTrials.gov ID
- NCT06339268
- Acronym / sponsor ID
- COGNITION / MMABelgrade
- Conditions
- Prehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Military Medical Academy, Belgrade, SerbiaUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The first group (intervention) where the patient will receive preoperative cognitive stimulation and physical therapy for one month before surgical treatment.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Cognitive training, CogniFit AppPatients 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. |
| Control group | No intervention | –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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive training, CogniFit AppAlso: Physical therapyA patient will receive preoperative cognitive stimulation and physical therapy for one month before surgical treatment. | Behavioural | Intervention group |
Primary outcome
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
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
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
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
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.
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.
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
3 secondary outcomes
Overall outcome: Complication rate
Time frame: From surgery until 30th postoperative day
Overall outcome: Morbidity
Time frame: From surgery until 30th postoperative day
Overall outcome: Mortality
Time frame: From surgery until 30th postoperative day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Background: PubMed 13243706BEDFORD 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.
- Background: PubMed 24303859Strom 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.
- Background: PubMed 29161395Needham 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.
- Background: PubMed 32358253Carli F. Prehabilitation for the Anesthesiologist. Anesthesiology. 2020 Sep;133(3):645-652. doi: 10.1097/ALN.0000000000003331. No abstract available.
- Background: PubMed 31166241Daiello 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.
- Background: PubMed 25306127Wang 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.
- Background: PubMed 34882939Sugimoto 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.
- Background: PubMed 34257192Gracie 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.
- Background: PubMed 31732585Durrand J, Singh SJ, Danjoux G. Prehabilitation. Clin Med (Lond). 2019 Nov;19(6):458-464. doi: 10.7861/clinmed.2019-0257.
- Derived from this study: PubMed 41387902Neskovic V, Markovic M, Maric N, Kostic S. Effect of preoperative cognitive and physical optimization in the prevention of postoperative cognitive deficit in elderly patients with lung resection - cognition trial. Trials. 2025 Dec 12;27(1):44. doi: 10.1186/s13063-025-08894-8.
- Individual participant dataSharing planned: Yes. All of the individual participant data that are collected during the trial, after identification will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vojislava Neskovic, PhD principal investigator
Military Medical Academy, Bulgaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training, CogniFit App in people with Prehabilitation, run by Military Medical Academy, Belgrade, Serbia at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vojislava Neskovic, PhD (+381641775320, vojkan43@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative cognitive dysfunction (time frame: From 1 month preoperatively (schedulling patient for surgery) until 30th postoperative day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06339268, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.