Меню
Набор скоро начнётся NCT07332052

Predicting of Frailty

Наблюдательное Femur Fractures Frailty Sarcopenia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Clinical and Functional Assessment, Rectus femoris thickness measurement.
Кому может быть актуально
Состояния в реестре: Femur Fractures, Frailty, Sarcopenia. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

  • Другое 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.
  • Другое Rectus femoris thickness measurement
    By using ultrasound linear prob the thickness of rectus femoris muscle will be measured

Первичные конечные точки

  • Correlation between Rectus Femoris Muscle Thickness and Frailty Score [Срок оценки: Preoperative (within 24 hours before surgery)]
Вторичные конечные точки (3)
  • Predictive Value of Handgrip Strength for Frailty [Срок оценки: Preoperative]
  • Correlation of Laboratory Biomarkers with Frailty Status [Срок оценки: 1 day before operation]
  • Hematological Indicators of Frailty [Срок оценки: 1 day before operation]

Критерии участия

Критерии включения

  • 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).

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Muğla Sıtkı Koçman University Training and Research Hospital — Muğla

Публикации

  • Mehmet H, Yang AWH, Robinson SR. Measurement of hand grip strength in the elderly: A scoping review with recommendations. J Bodyw Mov Ther. 2020 Jan;24(1):235-243. doi: 10.1016/j.jbmt.2019.05.029. Epub 2019 May 24. PMID 31987550
  • Sabatino A, Regolisti G, Bozzoli L, Fani F, Antoniotti R, Maggiore U, Fiaccadori E. Reliability of bedside ultrasound for measurement of quadriceps muscle thickness in critically ill patients with acute kidney injury. Clin Nutr. 2017 Dec;36(6):1710-1715. doi: 10.1016/j.clnu.2016.09.029. Epub 2016 Oct 1. PMID 27743614
  • Saglam Oz M, Toprak B, Bora R, Demir I. The Role of Hematological Parameters in Critically Ill Patients: Mortality Prediction in Elderly Intensive Care Unit Patients. Cureus. 2025 Apr 13;17(4):e82183. doi: 10.7759/cureus.82183. eCollection 2025 Apr. PMID 40364870

Идентификаторы

NCT: NCT07332052 · 250066

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗