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NCT Number: NCT07424170

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preoperative physical activity level

Behavioral

Before the surgery, the activity levels of the participants over the past week were assessed using the Physical Activity Scale for the Elderly (PASE).

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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