Postoperative Cognitive DeclineINCORENCT04493996
Increasing Preoperative Cognitive Reserve to Prevent Postoperative Cognitive Dysfunction in Cardiac Surgical Patients
A study testing Cognitive training in people with Postoperative Cognitive Decline and Postoperative Delirium, run by Heart and Brain Research Group, Germany at 1 site in Germany.
Trial summary
Postoperative delirium (POD) and postoperative cognitive decline (POCD) can be observed after cardiosurgical interventions. Taken together, these postoperative neurocognitive dysfunctions contribute to increased morbidity and mortality and higher economic costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Cognitive Decline, Postoperative Delirium, Postoperative Cognitive Dysfunction
- What is being tested?
- Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 14 Aug 2020to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective cardiac surgery (coronary artery bypass surgery, aortic or mitral valve replacement/reconstruction, or combination surgery) with standardized extracorporeal circulation
- A sufficiently good knowledge of German is necessary as cognitive training and neuropsychological tests are language-dependent
Who cannot join
- History of stroke and preexisting psychiatric or neurological disorders that may impair the neuropsychological performance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Cardiac Surgery, Kerckhoff-Klinik GmbH
Bad Nauheim, 61231
Marius Butz, +496032 996 5812, m.butz@kerckhoff-klinik.de
About this study
Official title: Increasing Preoperative Cognitive Reserve to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients. A Randomized Controlled Trial on Cognitive Training
Postoperative delirium (POD) and postoperative cognitive decline (POCD) can be observed after cardiosurgical interventions. Taken together, these postoperative neurocognitive dysfunctions contribute to increased morbidity and mortality and higher economic costs. Preoperative risk factors of postoperative neurocognitive dysfunctions, such as decreased neuropsychometric performance or decreased cognitive daily activities, can be interpreted as reduced cognitive reserve. The aim of this study is to build up cognitive reserves to protect against the development of POD and POCD through preoperative, home-based, cognitive training.
Read the detailed description
The planned research project is a monocentric, 2-arm randomized controlled intervention study involving 100 patients undergoing elective cardiac surgery with extracorporeal circulation. Patients will be assigned to a training group or control group. The intervention involves a standardized, paper-and-pencil-based cognitive training that will be performed by the patients at home for approximately 40 minutes per day over a preoperative period of 2-3 weeks. The control group will receive neither cognitive training nor a placebo intervention. A detailed assessment of psychological functions will be performed approximately 2-3 weeks before the start of training, at the end of the training, during hospitalization, at discharge from the acute clinic, and 3 months after surgery. The primary objective of this study is to investigate the interventional effect of preoperative cognitive training on the incidence of POD during the stay in the acute clinic, the incidence of POCD at the time of discharge from the acute clinic, and 3 months after surgery. Secondary objectives are to determine the training effect on objective cognitive functions before the surgery and subjective cognitive functions, as well as health-related quality of life 3 months after surgery.
- Conditions
- Postoperative Cognitive Decline, Postoperative Delirium, Postoperative Cognitive Dysfunction
- Being tested
- Cognitive training
- Keywords
- Cardiac Surgery, Postoperative Cognitive Decline, Postoperative Delirium, Cognitive Training, Cognitive Reserve, Postoperative Cognitive Dysfunction
- Medical subject headings
- Postoperative Cognitive Complications, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingBehavioural
The cognitive training involves a standardized, paper-and-pencil-based cognitive training that will be performed by the patients at home for approximately 40 minutes per day over a preoperative period of 2-3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cognitive training group | Experimental | Not described Receives: Behavioral: Cognitive training |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with postoperative cognitive decline at 3 months after surgery, defined as a decrease between pre- and postoperative examinations of one standard deviation in at least 20% of all objective neuropsychological parameters
The objective neuropsychological parameters measure cognitive domains like Immediate memory span, free recall, recognition memory, selective attention, working memory, inhibition and word fluency. These cognitive domains will be measured with the following instruments: "Verbaler Lern- und Merkfähigkeitstest" (VLMT), "Brief Visuospatial Memory Test-Revised" (BVMT-R), "Trail Making Test A/B" (TMT), "Letter Number Span Test" (LNS), "Regensburger Wortflüssigkeits-Test" (RWT), and "Syndrom-Kurz Test" (SKT-7).
Measured: Immediately pre-training to 3 month post-surgery
Number of participants with postoperative cognitive decline at the time of discharge from the acute clinic, defined as a decrease between the pre- and postoperative examinations of one standard deviation measured with the "Montreal Cognitive Assessment"
The "Montreal Cognitive Assessment" (MOCA) is a screening procedure for general cognitive function.
Measured: Immediately pre-training to approximately 1 week post-surgery
Number of participants with postoperative delirium during the stay in the intensive care unit as assessed using the "Intensive Care Delirium Screening Checklist" (ICDSC)
Postoperative delirium is defined as the occurrence of at least one delirious episode during a stay in the intensive care unit. The "Intensive Care Delirium Screening Checklist" (ICDSC) record the clinical symptoms of consciousness, attention, orientation, hallucinations, psychomotor retardation or agitation, speech, and changing symptoms by observing behavior and asking concrete questions to the patient.
Measured: Immediately post-surgery to approximately 1-2 days post-surgery
Number of participants with postoperative delirium during the stay on normal ward as assessed using the "Confusion Assessment Method" (3D-CAM)
Postoperative delirium is defined as the occurrence of at least one delirious episode during a stay in an intensive care unit or normal ward. The "Confusion Assessment Method" (3D-CAM) record the clinical symptoms of consciousness, attention, orientation, hallucinations, psychomotor retardation or agitation, speech, and changing symptoms by observing behavior and asking concrete questions to the patient.
Measured: Approximately 1 week (Immediately post-intensive care unit to approximately 1 week post-intensive care unit)
Secondary outcomes (13)
Change from baseline cognitive failures in everyday life at 3 months after surgery as assessed using the "Cognitive Failures Questionnaire" (CFQ)
The "Cognitive Failures Questionnaire" (CFQ) measure the frequency of failures in daily living in terms of memory, attention, action, and perception.
Measured: Immediately pre-training to 3 month post-surgery
Change from baseline health-related quality of life at 3 months after surgery as assessed using the "36-Item Short Form Health Survey" (SF36)
The "36-Item Short Form Health Survey" (SF36) includes 36 questions covering 8 health-related factors: vitality, physical functioning, bodily pain, general health perception, physical role function, emotional role function, social role functioning, and mental health.
Measured: Immediately pre-training to 3 month post-surgery
Change from baseline visual immediate memory span at the end of cognitive training as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)
In the "Brief Visuospatial Memory Test-Revised" (BVMT-R), the patient is shown six geometric figures for 10 seconds on a DIN A4 sheet of paper, which are to be drawn directly afterward. This procedure is repeated with the same figures in a total of three learning trials. The figures are to be freely replicated in a time-delayed episode with following recognition help.
Measured: Immediately pre-training to approximately 2-3 weeks post-training
Change from baseline visual free recall at the end of cognitive training as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)
In the "Brief Visuospatial Memory Test-Revised" (BVMT-R), the patient is shown six geometric figures for 10 seconds on a DIN A4 sheet of paper, which are to be drawn directly afterward. This procedure is repeated with the same figures in a total of three learning trials. The figures are to be freely replicated in a time-delayed episode with following recognition help.
Measured: Immediately pre-training to approximately 2-3 weeks post-training
Change from baseline visual recognition memory at the end of cognitive training as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)
In the "Brief Visuospatial Memory Test-Revised" (BVMT-R), the patient is shown six geometric figures for 10 seconds on a DIN A4 sheet of paper, which are to be drawn directly afterward. This procedure is repeated with the same figures in a total of three learning trials. The figures are to be freely replicated in a time-delayed episode with following recognition help.
Measured: Immediately pre-training to approximately 2-3 weeks post-training
Change from baseline verbal immediate memory span at the end of cognitive training as assessed using the "Verbaler Lern- und Merkfähigkeitstest" (VLMT)
In the "Verbaler Lern- und Merkfähigkeitstest" (VLMT), a list of words is learned over five learning trials, which, after a interference word list, is to be remembered directly and with a delay of about 20 minutes. With subsequent recognition help, the verbal discrimination ability is measured.
Measured: Immediately pre-training to approximately 2-3 weeks post-training
Change from baseline verbal free recall at the end of cognitive training as assessed using the "Verbaler Lern- und Merkfähigkeitstest" (VLMT)
In the "Verbaler Lern- und Merkfähigkeitstest" (VLMT), a list of words is learned over five learning trials, which, after a interference word list, is to be remembered directly and with a delay of about 20 minutes. With subsequent recognition help, the verbal discrimination ability is measured.
Measured: Immediately pre-training to approximately 2-3 weeks post-training
Change from baseline verbal recognition memory at the end of cognitive training as assessed using the "Verbaler Lern- und Merkfähigkeitstest" (VLMT)
In the "Verbaler Lern- und Merkfähigkeitstest" (VLMT), a list of words is learned over five learning trials, which, after a interference word list, is to be remembered directly and with a delay of about 20 minutes. With subsequent recognition help, the verbal discrimination ability is measured.
Measured: Immediately pre-training to approximately 2-3 weeks post-training
Change from baseline selective attention at the end of cognitive training as assessed using the "Trail Making Test A" (TMT)
In the "Trail Making Test A" (TMT-A), the patient has to connect numbers in ascending order on a test sheet as fast as possible.
Measured: Immediately pre-training to approximately 2-3 weeks post-training
Change from baseline verbal working memory at the end of cognitive training as assessed using the "Letter Number Span Test" (LNS)
In the "Letter Number Span Test" (LNS), the patient is supposed to rearrange a mixed sequence of letters and numbers through mental reorganization in such a way that first all numbers and then all letters are to be named in ascending order.
Measured: Immediately pre-training to approximately 2-3 weeks post-training
Change from baseline cognitive flexibility at the end of cognitive training as assessed using the "Trail Making Test B" (TMT)
With the "Trail Making Test B" (TMT-B), the patient's task is to connect numbers and letters alternately in ascending order.
Measured: Immediately pre-training to approximately 2-3 weeks post-training
Change from baseline inhibition at the end of cognitive training as assessed using the "Syndrom-Kurz Test" (SKT-7)
In the "Syndrom-Kurz Test" (SKT-7), the patient has to rename a series of letters (e.g., "A" instead of "B," and vice versa).
Measured: Immediately pre-training to approximately 2-3 weeks post-training
Change from baseline word fluency at the end of cognitive training as assessed using the "Regensburger Wortflüssigkeits-Test" (RWT)
In the "Regensburger Wortflüssigkeits-Test" (RWT), the patient has to name in one minute as many words as possible from a certain category.
Measured: Immediately pre-training to approximately 2-3 weeks post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start14 Aug 2020
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DeclineStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart and Brain Research Group, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marius Butz, Dipl.-Psych., Principal investigator, Department of Cardiac Surgery, Kerckhoff Clinic Bad NauheimMartin Jünemann, Dr.med,M.Sc., Principal investigator, Clinic for Neurology, University Hospital GießenTibo Gerriets, Prof.Dr.med., Principal investigator, Department of Neurology, Gesundheitszentrum WetterauMarkus Schönburg, Prof.Dr.med., Principal investigator, Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493996
- Sponsor's protocol ID
- 48/20
- Acronym
- INCORE
- Status last verified
- Feb 2026
- First submitted
- 21 Jul 2020
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Preoperative Cognitive Reserve to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients. A Randomized Controlled Trial on Cognitive Training
- ClinicalTrials.gov ID
- NCT04493996
- Acronym / sponsor ID
- INCORE / 48/20
- Conditions
- Postoperative Cognitive Decline, Postoperative Delirium, Postoperative Cognitive Dysfunction
- Keywords
- Cardiac Surgery, Postoperative Cognitive Decline, Postoperative Delirium, Cognitive Training, Cognitive Reserve, Postoperative Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Heart and Brain Research Group, GermanyUniversity, hospital or other
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 31 Jul 2020 (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 delirium (POD) and postoperative cognitive decline (POCD) can be observed after cardiosurgical interventions. Taken together, these postoperative neurocognitive dysfunctions contribute to increased morbidity and mortality and higher economic costs. Preoperative risk factors of postoperative neurocognitive dysfunctions, such as decreased neuropsychometric performance or decreased cognitive daily activities, can be interpreted as reduced cognitive reserve. The aim of this study is to build up cognitive reserves to protect against the development of POD and POCD through preoperative, home-based, cognitive training.
Detailed description
The planned research project is a monocentric, 2-arm randomized controlled intervention study involving 100 patients undergoing elective cardiac surgery with extracorporeal circulation. Patients will be assigned to a training group or control group. The intervention involves a standardized, paper-and-pencil-based cognitive training that will be performed by the patients at home for approximately 40 minutes per day over a preoperative period of 2-3 weeks. The control group will receive neither cognitive training nor a placebo intervention. A detailed assessment of psychological functions will be performed approximately 2-3 weeks before the start of training, at the end of the training, during hospitalization, at discharge from the acute clinic, and 3 months after surgery. The primary objective of this study is to investigate the interventional effect of preoperative cognitive training on the incidence of POD during the stay in the acute clinic, the incidence of POCD at the time of discharge from the acute clinic, and 3 months after surgery. Secondary objectives are to determine the training effect on objective cognitive functions before the surgery and subjective cognitive functions, as well as health-related quality of life 3 months after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive training group | Experimental | Behavioral: Cognitive training |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective cardiac surgery (coronary artery bypass surgery, aortic or mitral valve replacement/reconstruction, or combination surgery) with standardized extracorporeal circulation
- A sufficiently good knowledge of German is necessary as cognitive training and neuropsychological tests are language-dependent
Key exclusion criteria (1 listed)
- History of stroke and preexisting psychiatric or neurological disorders that may impair the neuropsychological performance
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 trainingThe cognitive training involves a standardized, paper-and-pencil-based cognitive training that will be performed by the patients at home for approximately 40 minutes per day over a preoperative period of 2-3 weeks | Behavioural | Cognitive training group |
Primary outcome
Number of participants with postoperative cognitive decline at 3 months after surgery, defined as a decrease between pre- and postoperative examinations of one standard deviation in at least 20% of all objective neuropsychological parameters
Time frame: Immediately pre-training to 3 month post-surgery
The objective neuropsychological parameters measure cognitive domains like Immediate memory span, free recall, recognition memory, selective attention, working memory, inhibition and word fluency. These cognitive domains will be measured with the following instruments: "Verbaler Lern- und Merkfähigkeitstest" (VLMT), "Brief Visuospatial Memory Test-Revised" (BVMT-R), "Trail Making Test A/B" (TMT), "Letter Number Span Test" (LNS), "Regensburger Wortflüssigkeits-Test" (RWT), and "Syndrom-Kurz Test" (SKT-7).
Number of participants with postoperative cognitive decline at the time of discharge from the acute clinic, defined as a decrease between the pre- and postoperative examinations of one standard deviation measured with the "Montreal Cognitive Assessment"
Time frame: Immediately pre-training to approximately 1 week post-surgery
The "Montreal Cognitive Assessment" (MOCA) is a screening procedure for general cognitive function.
Number of participants with postoperative delirium during the stay in the intensive care unit as assessed using the "Intensive Care Delirium Screening Checklist" (ICDSC)
Time frame: Immediately post-surgery to approximately 1-2 days post-surgery
Postoperative delirium is defined as the occurrence of at least one delirious episode during a stay in the intensive care unit. The "Intensive Care Delirium Screening Checklist" (ICDSC) record the clinical symptoms of consciousness, attention, orientation, hallucinations, psychomotor retardation or agitation, speech, and changing symptoms by observing behavior and asking concrete questions to the patient.
Number of participants with postoperative delirium during the stay on normal ward as assessed using the "Confusion Assessment Method" (3D-CAM)
Time frame: Approximately 1 week (Immediately post-intensive care unit to approximately 1 week post-intensive care unit)
Postoperative delirium is defined as the occurrence of at least one delirious episode during a stay in an intensive care unit or normal ward. The "Confusion Assessment Method" (3D-CAM) record the clinical symptoms of consciousness, attention, orientation, hallucinations, psychomotor retardation or agitation, speech, and changing symptoms by observing behavior and asking concrete questions to the patient.
13 secondary outcomes
Change from baseline cognitive failures in everyday life at 3 months after surgery as assessed using the "Cognitive Failures Questionnaire" (CFQ)
Time frame: Immediately pre-training to 3 month post-surgery
Change from baseline health-related quality of life at 3 months after surgery as assessed using the "36-Item Short Form Health Survey" (SF36)
Time frame: Immediately pre-training to 3 month post-surgery
Change from baseline visual immediate memory span at the end of cognitive training as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)
Time frame: Immediately pre-training to approximately 2-3 weeks post-training
Change from baseline visual free recall at the end of cognitive training as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)
Time frame: Immediately pre-training to approximately 2-3 weeks post-training
Change from baseline visual recognition memory at the end of cognitive training as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)
Time frame: Immediately pre-training to approximately 2-3 weeks post-training
Change from baseline verbal immediate memory span at the end of cognitive training as assessed using the "Verbaler Lern- und Merkfähigkeitstest" (VLMT)
Time frame: Immediately pre-training to approximately 2-3 weeks post-training
Change from baseline verbal free recall at the end of cognitive training as assessed using the "Verbaler Lern- und Merkfähigkeitstest" (VLMT)
Time frame: Immediately pre-training to approximately 2-3 weeks post-training
Change from baseline verbal recognition memory at the end of cognitive training as assessed using the "Verbaler Lern- und Merkfähigkeitstest" (VLMT)
Time frame: Immediately pre-training to approximately 2-3 weeks post-training
Change from baseline selective attention at the end of cognitive training as assessed using the "Trail Making Test A" (TMT)
Time frame: Immediately pre-training to approximately 2-3 weeks post-training
Change from baseline verbal working memory at the end of cognitive training as assessed using the "Letter Number Span Test" (LNS)
Time frame: Immediately pre-training to approximately 2-3 weeks post-training
Change from baseline cognitive flexibility at the end of cognitive training as assessed using the "Trail Making Test B" (TMT)
Time frame: Immediately pre-training to approximately 2-3 weeks post-training
Change from baseline inhibition at the end of cognitive training as assessed using the "Syndrom-Kurz Test" (SKT-7)
Time frame: Immediately pre-training to approximately 2-3 weeks post-training
Change from baseline word fluency at the end of cognitive training as assessed using the "Regensburger Wortflüssigkeits-Test" (RWT)
Time frame: Immediately pre-training to approximately 2-3 weeks post-training
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 17 Feb 2026.
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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.
Marius Butz, Dipl.-Psych. principal investigator
Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim
Martin Jünemann, Dr.med,M.Sc. principal investigator
Clinic for Neurology, University Hospital Gießen
Tibo Gerriets, Prof.Dr.med. principal investigator
Department of Neurology, Gesundheitszentrum Wetterau
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 in people with Postoperative Cognitive Decline and Postoperative Delirium, run by Heart and Brain Research Group, Germany at 1 site in Germany.
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 2 inclusion and 1 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 17 Feb 2026. 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 Germany. 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 Marius Butz, Dipl.-Psych. (+496032 996 5812, m.butz@kerckhoff-klinik.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with postoperative cognitive decline at 3 months after surgery, defined as a decrease between pre- and postoperative examinations of one standard deviation in at least 20% of all objective neuropsychological parameters (time frame: Immediately pre-training to 3 month post-surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.