NCT07322809

Brief Summary

Frailty is a key predictor of adverse outcomes in older surgical patients, yet its longitudinal evolution and potentially reversible nature remain underexplored in perioperative settings. This study aimed to characterize postoperative frailty trajectories in older patients and to examine their association with one-year mortality, as well as factors influencing trajectory group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,417

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
Last Updated

January 9, 2026

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

December 23, 2025

Last Update Submit

January 8, 2026

Conditions

Keywords

Frailty trajectoryolder surgical patientsone-year mortalitylatent class trajectory modeling

Outcome Measures

Primary Outcomes (1)

  • The primary outcome was one-year all-cause mortality.

    The primary outcome was one-year all-cause mortality, determined through structured telephone follow-up.

    At the one-year postoperative follow-up.

Study Arms (1)

A retrospective cohort study based on prospectively collected data.

Patients' frailty was assessed using the FRAIL scale at four time points: preoperatively and at 1, 3, and 6 months postoperatively. Patients were classified into distinct frailty trajectory groups using latent class trajectory modeling. The study examined the associations between frailty trajectories and one-year mortality and further identified independent factors associated with frailty trajectory membership.

Eligibility Criteria

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

Patients' frailty was assessed using the FRAIL scale at four time points: preoperatively and at 1, 3, and 6 months postoperatively. Patients were classified into distinct frailty trajectory groups using latent class trajectory modeling. One-year all-cause mortality was ascertained through structured telephone follow-up.

You may qualify if:

  • Aged ≥65 years;
  • Underwent elective non-cardiac, non-neurosurgical procedures;
  • Completed standardized frailty assessments both preoperatively and postoperatively.

You may not qualify if:

  • Severe dementia, language disorders, significant hearing or visual impairments, or coma;
  • Cognitive function below the Mini-Mental State Examination (MMSE) thresholds (\<18 for illiterate individuals, \<21 for individuals with primary education, and \<25 for individuals with secondary education or higher);
  • Surgery performed under local anesthesia or monitored anesthesia care;
  • Surgical duration ≤30 minutes;
  • Missing data on postoperative complications or one-year mortality required for this study;
  • Incomplete frailty assessments at 1, 3, and 6 months after surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

28 Fuxing Road, Haidian District

Beijin, Beijing Municipality, 100853, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Chief of administration, Anesthesiology

Study Record Dates

First Submitted

December 23, 2025

First Posted

January 7, 2026

Study Start

April 1, 2020

Primary Completion

April 30, 2022

Study Completion

April 30, 2023

Last Updated

January 9, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations