NCT07424170

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Mar 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Mar 2026Dec 2026

First Submitted

Initial submission to the registry

February 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2026

Expected
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 10, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

February 15, 2026

Last Update Submit

March 7, 2026

Conditions

Keywords

exerciseirisinPost Operative Delirium

Outcome Measures

Primary Outcomes (1)

  • 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).

    five days after surgery

Study Arms (2)

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

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

Interventions

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

Insufficient Daily ExerciseRegular Daily Exercise

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Emergence DeliriumMotor Activity

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental DisordersBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of Department of Anesthesiology

Study Record Dates

First Submitted

February 15, 2026

First Posted

February 20, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

December 26, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 10, 2026

Record last verified: 2026-02