Predicting of Frailty (PRE-FRAIL)

December 30, 2025 updated by: ali ihsan uysal

Comparison of Parameters That Can be Used to Predict Frailty in Elderly Femur Fracture Patients.

This study aims to evaluate the frailty status of elderly patients undergoing surgery for hip fractures (femur trochanteric fractures). Since frailty is a critical factor in surgical outcomes and recovery, researchers want to find simple, fast, and objective ways to measure it. This study will investigate muscle thickness measured by ultrasound, handgrip strength measured by a dynamometer, and routine blood test values can accurately predict a patient's frailty level. If these objective methods are proven effective, it will help anesthesia and surgical teams manage the perioperative process more safely for high-risk elderly patients

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

65 and over years old elderly patients admitted to the orthopedics department with a diagnosis of trochanteric femur fracture will be enrolled in this study.

Preoperative Assessment: A researcher anesthesiologist, who is not involved in the patient's perioperative clinical management, will conduct the assessments to ensure objectivity. One day prior to the scheduled surgery, the following procedures will be performed:

Frailty Evaluation: Clinical frailty status will be determined using the Clinical Frailty Scale. In conjunction with this, handgrip strength will be measured using a calibrated hand dynamometer.

Ultrasonographic Measurements: Ultrasound will be used to measure the thickness of the rectus femoris muscle and the distance from the femur to the skin. These measurements will serve as objective indicators of musculoskeletal status.

Data Collection: Demographic data (age, weight, height, comorbidities) and routine preoperative laboratory results will be recorded from the hospital's electronic medical records. Laboratory parameters to be analyzed include:

Hematological: Hemoglobin, MPV, MCV, Neutrophil, and Lymphocyte counts.

Biochemical: Albumin, Creatinine, CRP, and GFR.

The study focuses on evaluating the correlation between these objective measurements (ultrasound and dynamometry) and the established clinical frailty scores to determine their predictive value in the geriatric surgical population.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Menteşe
      • Muğla, Menteşe, Turkey (Türkiye), 48000
        • Muğla Sıtkı Koçman University Training and Research Hospital

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

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of geriatric patients aged 65 years and older who have been hospitalized at the Orthopedics and Traumatology department of Mugla Sitki Kocman University Training and Research Hospital with a diagnosis of trochanteric femur fracture. This population includes patients scheduled for elective or semi-urgent orthopedic surgery who are capable of undergoing preoperative clinical and ultrasonographic assessments.

Description

Inclusion Criteria:

  • Patients aged 65 years and older.
  • Confirmed diagnosis of trochanteric femur fracture.
  • Planned for orthopedic surgery under general or regional anesthesia.
  • Ability to provide written informed consent (either by the patient or a legal representative).

Exclusion Criteria:

  • Patients with advanced dementia or severe cognitive impairment who cannot cooperate with the handgrip strength test or Fried criteria questionnaire.
  • Patients with terminal-stage diseases or those under palliative care.
  • History of neuromuscular diseases or severe muscle-wasting conditions that affect the lower limbs (e.g., advanced muscular dystrophy).
  • Patients with active infections or skin lesions at the site of ultrasound measurement (rectus femoris area).
  • Emergency cases requiring immediate surgery where preoperative assessment cannot be completed.

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
Elderly Hip Fracture Patients
Patients aged 65 and older who have been diagnosed with a trochanteric femur fracture and are scheduled for orthopedic surgery.
Other: Clinical and Functional Assessment
Assessment of frailty status using the Clinical Frailty Scale and measurement of handgrip strength using a hand dynamometer (measured in kilograms). Ultrasonographic measurement of the rectus femoris muscle thickness (mm) and femur-skin distance (mm) conducted one day before surgery.
Other Names:
  • Clinical Frailty Scale
  • Hand Dynamometry
  • Rectus Femoris Ultrasound
  • Sarcopenia Screening via Ultrasound
Other: Rectus femoris thickness measurement
By using ultrasound linear prob the thickness of rectus femoris muscle will be measured

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between Rectus Femoris Muscle Thickness and Frailty Score
Time Frame: Preoperative (within 24 hours before surgery)
Evaluation of the relationship between clinical frailty status (measured by the Clinical Frailty Scale) and objective muscle mass (measured as rectus femoris thickness in millimeters via ultrasonography). Over 5 point indicate frailty.
Preoperative (within 24 hours before surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive Value of Handgrip Strength for Frailty
Time Frame: Preoperative
Assessment of handgrip strength using a hand dynamometer to evaluate its correlation with the Frailty Score.
Preoperative
Correlation of Laboratory Biomarkers with Frailty Status
Time Frame: 1 day before operation
Evaluation of the relationship between frailty and preoperative blood levels of Albumin, C-Reactive Protein (CRP), Glomerular Filtration Rate (GFR)
1 day before operation
Hematological Indicators of Frailty
Time Frame: 1 day before operation
Analysis of Hemoglobin levels and Neutrophil-to-Lymphocyte Ratio (NLR) in relation to the patient's frailty score.
1 day before operation

Collaborators and Investigators

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

Sponsor

ali ihsan uysal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 20, 2026

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

August 15, 2026

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

December 30, 2025

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 250066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared to protect the privacy of the participants and to maintain confidentiality in accordance with the institutional review board's (Mugla Sitki Kocman University Ethics Committee) regulations and local data protection laws.

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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