The Effect of Exercise-Induced Irisin on Brain Function and Postoperative Delirium in Older Adults

March 7, 2026 updated by: Yi Feng, MD, Peking University People's Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

140

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for elective surgery at Peking University People's Hospital.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Insufficient Daily Exercise
The participants with a PASE score less than 104 were classified as the group with insufficient daily physical activity.
Behavioral: Preoperative physical activity level
Before the surgery, the activity levels of the participants over the past week were assessed using the Physical Activity Scale for the Elderly (PASE).
Regular Daily Exercise
The participants with a PASE score of 104 or above are classified as the group with regular daily physical activity
Behavioral: Preoperative physical activity level
Before the surgery, the activity levels of the participants over the past week were assessed using the Physical Activity Scale for the Elderly (PASE).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
five days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

December 26, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 15, 2026

First Submitted That Met QC Criteria

February 15, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 7, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026PHB056-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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