跳至主要内容
临床试验/NCT03740061
NCT03740061Unknown不适用

The Evaluation of Acute Sarcopenia in Hospitalized Elderly: Muscle Characteristics Assessment Through Ultrasound

Universiteit Antwerpen1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Change over 7 days in ultrasonographic measured muscle cross-sectional area (in square centimeter) in the four bellies of the quadriceps muscle

研究概览

简要总结

Traditionally, muscle mass - a part of the concept of sarcopenia - is measured by computed tomography (CT) or dual-energy X-ray absorptiometry (DEXA) scan. These devices are not always easily available in clinical practice and cannot be used bedside. An innovation in sarcopenia is the assessment of muscle mass and quality with ultrasound. Because this device is much more available and applicable in all patients, diagnosis of acute sarcopenia would be much easier with ultrasound. Moreover, if other factors that contribute to accelerated decline in muscle mass and function can be determinated, the sensiblisation and early screening for acute sarcopenia in those individuals can hopefully prevent them from declining.

详细描述

Methods Study design A prospective, multicenter, international observational study will be conducted. The study is designed to determine the effect of hospitalisation due to acute illness on the changes in muscle mass and muscle function. The secondary endpoint of the study is to identify health related parameters associated with the development of acute sarcopenia.

Subjects Inclusion criteria Patients admitted between the 1st of December 2018 until the 31th of November 2019 will be eligible for inclusion. Included wards for admission are: internal medicine, acute geriatrics, orthogeriatrics and rehabilitation. Age limit will be set on 65 years and older.

Exclusion criteria Patients on dialysis will be excluded because of possible metabolic features. Individuals with paresis of the lower limbs or hemiparesis due to a stroke will be excluded because of neurological involvement that can influence the results. Hypo-or hyperthyroid patients will be excluded because of the role of thyroid hormones in muscle homeostasis. Pitting oedema of the legs (due to heart failure, anasarca oedema, renal failure or liver cirrhosis) or severely dehydrated patients will be excluded because fluid shifts could influence the ultrasound measurement results. Because of possible previous changes in muscle mass, architecture and function, patients with systemic connective tissue disorders, myositis, calcification and ossification of muscle, systemic atrophies primarily affecting the central nervous system and demyelinating diseases of the central nervous system will be excluded. Patients using chronic oral corticosteroids will be excluded.

Settings and locations The study will be a multicenter study held in different university and tertiary teaching hospitals throughout Europe.

Measurements

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • All participants ages 65 years AND
  • Admitted to one of the ward of one of the centers in the given time period.

排除标准

  • Patients on dialysis will be excluded because of possible metabolic features.
  • Individuals with paresis of the lower limbs or hemiparesis due to a stroke will be excluded because of neurological involvement that can influence the results.
  • Hypo-or hyperthyroid patients will be excluded because of the role of thyroid hormones in muscle homeostasis.
  • Pitting oedema of the legs (due to heart failure, anasarca oedema, renal failure or liver cirrhosis) or severely dehydrated patients will be excluded because fluid shifts could influence the ultrasound measurement results.
  • Because of possible previous changes in muscle mass, architecture and function, patients with systemic connective tissue disorders, myositis, calcification and ossification of muscle, systemic atrophies primarily affecting the central nervous system and demyelinating diseases of the central nervous system will be excluded.
  • Patients using chronic oral corticosteroids will be excluded.

结局指标

主要结局

Change over 7 days in ultrasonographic measured muscle cross-sectional area (in square centimeter) in the four bellies of the quadriceps muscle

时间窗: 7 days

Change over 7 days in ultrasonographic measured muscle cross-sectional area (in square centimeter) in the four bellies of the quadriceps muscle

Change over 7 days in ultrasonographic measured muscle thickness (in centimeter) in the four bellies of the quadriceps muscle

时间窗: 7 days

Change over 7 days in ultrasonographic measured muscle thickness (in centimeter) in the four bellies of the quadriceps muscle

Change over 7 days in ultrasonographic measured muscle pennation angle (in degrees) in the four bellies of the quadriceps muscle

时间窗: 7 days

Change over 7 days in ultrasonographic measured muscle pennation angle (in degrees) in the four bellies of the quadriceps muscle

Change over 7 days in ultrasonographic measured muscle echo-intensity (gray values in Houndsfield units) in the four bellies of the quadriceps muscle

时间窗: 7 days

Change over 7 days in ultrasonographic measured muscle echo-intensity (gray values in Houndsfield units) in the four bellies of the quadriceps muscle

Change over 7 days in ultrasonographic measured muscle fascicle length (in centimeter) in the four bellies of the quadriceps muscle

时间窗: 7 days

Change over 7 days in ultrasonographic measured muscle fascicle length (in centimeter) in the four bellies of the quadriceps muscle

次要结局

  • Influence of muscle echo intensity on muscle strength measured by hand grip strength (kg)(7 days)
  • Influence of muscle thickness on muscle strength measured by hand grip strength(7 days)
  • Influence of muscle cross-sectional area on muscle function measured by short physical performance battery(7 days)
  • Influence of muscle fascicle length on muscle strength measured by hand grip strength (kg)(7 days)
  • Influence of muscle fascicle length on muscle function measured by short physical performance battery(7 days)
  • Influence of muscle echo intensity on muscle function measured by short physical performance battery(7 days)
  • Influence of muscle cross-sectional area on muscle strength measured by hand grip strength(7 days)
  • Influence of muscle pennation angle on muscle strength measured by hand grip strength(7 days)
  • Influence of muscle pennation angle on muscle function measured by short physical performance battery(7 days)
  • Influence of muscle thickness on muscle function measured by short physical performance battery(7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stany Perkisas

Principal investigator

Universiteit Antwerpen

研究点 (1)

Loading locations...

相似试验