Post Operative DeliriumNCT07424170
The Effect of Exercise-Induced Irisin on Brain Function and Postoperative Delirium in Older Adults
An observational study of Post Operative Delirium, run by Peking University People's Hospital at 1 site in China.
Trial summary
The goal of this observational study is to learn how exercise-induced irisin protects the brain. It also explores irisin's effect on postoperative delirium (POD) in older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Operative Delirium
- What is being tested?
- Preoperative physical activity level
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 30 Jun 2027
- Phase
- Observational
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients scheduled for elective surgery at Peking University People's Hospital.
Who may be able to join
- Aged ≥ 65 years;
- Classified as ASA physical status I to III;
- Scheduled for non-cardiovascular surgery under spinal anesthesia or combined spinal-epidural anesthesia;
- Expected surgical duration of at least 2 hours;
- Voluntarily provide written informed consent and agree to participate in this study.
Who cannot join
- Significant change in exercise status within the past 7 days due to injury or other reasons;
- Contraindications to neuraxial anesthesia;
- Unable to assess cognitive function or Montreal Cognitive Assessment (MoCA) score < 23;
- Preoperative diagnosis of delirium;
- History of traumatic brain injury or neurosurgery;
- Long-term opioid use or history of alcohol abuse;
- Planned surgery cancelled or changed (including intraoperative events that significantly alter the procedure or duration);
- Change in anesthesia method.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Bailin Jiang, +86 138-1098-6114, 2511210366@bjmu.edu.cn
About this study
Official title: Association of the Exercise-Irisin-EEG Cascade With Intrinsic Brain Vulnerability and Its Impact on Postoperative Delirium in Elderly Patients: A Prospective Cohort Study
The goal of this observational study is to learn how exercise-induced irisin protects the brain. It also explores irisin's effect on postoperative delirium (POD) in older adults. The main questions it aims to answer are:
Does daily activity link to POD? Does irisin play a mediating role in this process? Researchers will enroll active and inactive adults aged 65 and older. All will have surgery under spinal anesthesia. The researchers will measure irisin levels in spinal fluid. They will track POD and other complications for five days after surgery.
- Conditions
- Post Operative Delirium
- Being tested
- Preoperative physical activity level
- Keywords
- exercise, irisin, Post Operative Delirium
- Medical subject headings
- Emergence Delirium, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative physical activity levelBehavioural
Before the surgery, the activity levels of the participants over the past week were assessed using the Physical Activity Scale for the Elderly (PASE).
| Study group | Role | What they receive |
|---|---|---|
| Insufficient Daily Exercise | The participants with a PASE score less than 104 were classified as the group with insufficient daily physical activity. Receives: Behavioral: Preoperative physical activity level | |
| Regular Daily Exercise | The participants with a PASE score of 104 or above are classified as the group with regular daily physical activity Receives: Behavioral: Preoperative physical activity level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Delirium
Delirium will be assessed using the CAM or CAM-ICU (for patients in the ICU) by researchers twice daily. For patients who develop POD, the severity of POD will be evaluated using the Delirium Rating Scale-Revised-98 (DRS-R-98).
Measured: five days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Jul 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative DeliriumStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424170
- Sponsor's protocol ID
- 2026PHB056-001
- Status last verified
- Sep 2026
- First submitted
- 15 Feb 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of the Exercise-Irisin-EEG Cascade With Intrinsic Brain Vulnerability and Its Impact on Postoperative Delirium in Elderly Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07424170
- Acronym / sponsor ID
- 2026PHB056-001
- Conditions
- Post Operative Delirium
- Keywords
- exercise, irisin, Post Operative Delirium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 Feb 2026 (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.
The goal of this observational study is to learn how exercise-induced irisin protects the brain. It also explores irisin's effect on postoperative delirium (POD) in older adults. The main questions it aims to answer are:
Does daily activity link to POD? Does irisin play a mediating role in this process? Researchers will enroll active and inactive adults aged 65 and older. All will have surgery under spinal anesthesia. The researchers will measure irisin levels in spinal fluid. They will track POD and other complications for five days after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insufficient Daily Exercise | – | Behavioral: Preoperative physical activity levelThe participants with a PASE score less than 104 were classified as the group with insufficient daily physical activity. |
| Regular Daily Exercise | – | Behavioral: Preoperative physical activity levelThe participants with a PASE score of 104 or above are classified as the group with regular daily physical activity |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients scheduled for elective surgery at Peking University People's Hospital.
Key inclusion criteria (5 listed)
- Aged ≥ 65 years;
- Classified as ASA physical status I to III;
- Scheduled for non-cardiovascular surgery under spinal anesthesia or combined spinal-epidural anesthesia;
- Expected surgical duration of at least 2 hours;
- Voluntarily provide written informed consent and agree to participate in this study.
Key exclusion criteria (8 listed)
- Significant change in exercise status within the past 7 days due to injury or other reasons;
- Contraindications to neuraxial anesthesia;
- Unable to assess cognitive function or Montreal Cognitive Assessment (MoCA) score < 23;
- Preoperative diagnosis of delirium;
- History of traumatic brain injury or neurosurgery;
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 |
|---|---|---|
| Preoperative physical activity levelBefore the surgery, the activity levels of the participants over the past week were assessed using the Physical Activity Scale for the Elderly (PASE). | Behavioural | Insufficient Daily Exercise, Regular Daily Exercise |
Primary outcome
Postoperative Delirium
Time frame: five days after surgery
Delirium will be assessed using the CAM or CAM-ICU (for patients in the ICU) by researchers twice daily. For patients who develop POD, the severity of POD will be evaluated using the Delirium Rating Scale-Revised-98 (DRS-R-98).
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 10 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative Delirium, run by Peking University People's Hospital at 1 site in China.
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 5 inclusion and 8 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 10 Sep 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Delirium (time frame: five days after surgery). 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 10 Sep 2026.