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临床试验/NCT06448871
NCT06448871已完成不适用

Usefulness of Ultrasound to Assess Sarcopenia in Individuals With Prader Willi Syndrome

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2022年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
1
主要终点
DXA: skeletal muscle (SM)

研究概览

简要总结

The aim of the study is to examine the clinical applicability of ultrasound as a diagnostic tool for sarcopenia in individuals with PWS by investigating the association between ultrasound-derived measurements, DXA-derived measurements, and sarcopenia-related outcomes.

详细描述

Sarcopenia is an age-related loss of muscle mass plus low muscle strength, and/or low physical performance, that may affect over 25% of individuals over the age of 60, resulting in an increased likelihood of developing disability. Abnormal body composition with an increased in body fat mass and a decreased in skeletal muscle mass were noted in individuals with Prader Willi syndrome (PWS), thought to be related to hormonal deficiencies due to hypothalamic dysfunction, presenting as a unique congenital model of sarcopenia.

Muscle mass can be measured by dual-energy X-ray absorptiometry (DXA) scan device, but it is expensive, increased radiation exposure, and not easily accessible in all clinical practice. Ultrasound (USD) is a non-invasive, without ionising radiation, low-cost, and easily accessible tool for the assessment of soft tissue. There were increasing evidence for the use of USD in the measurement of muscle thickness (MT), cross-sectional area (CSA) and pennate anle (PA) of different muscle groups in different populations. However, the use of USD as a routine diagnostic tool in individuals with PWS has not been reported yet.

The aim of the study is to examine the clinical applicability of ultrasound as a diagnostic tool for sarcopenia in individuals with PWS by investigating the association between ultrasound-derived measurements, DXA-derived measurements, and sarcopenia-related outcomes.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

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

入选标准

  • Genetically diagnosed individuals with PWS who can cooperate with the examinations

排除标准

  • Individuals with PWS who have arthritis, fractures, or severe musculoskeletal deformities that could interfere with the examinations.
  • Individuals with PWS who have severe cognitive impairment and are unable to read or sign the written consent.

结局指标

主要结局

DXA: skeletal muscle (SM)

时间窗: 1 day

Lean index of skeletal muscle (SM) with Hologic QDR-4500A, Hologic, Inc., Waltham, MA, USA

DXA: body fat mass (BFM)

时间窗: 1 day

Adipose index of body fat mass (BFM) using Hologic QDR-4500A, Hologic, Inc., Waltham, MA, USA.

DXA: appendicular skeletal muscle mass index (ASMI)

时间窗: 1 day

Lean index of appendicular skeletal muscle mass index (ASMI) with Hologic QDR-4500A, Hologic, Inc., Waltham, MA, USA

DXA: fat mass index (FMI)

时间窗: 1 day

Adipose index of fat mass index using Hologic QDR-4500A, Hologic, Inc., Waltham, MA, USA.

Muscle thickness ultrasound

时间窗: 1 day

Ultrasound scanning of the muscle thickness of rectus femoris (RF), vastus lateralis (VL), and gastrocnemius medialis (GM) using B-mode ultrasonography (LOGIQ S8, GE Healthcare, USA) and a 7-15 MHz linear array transducer.

Pennation angle ultrasound

时间窗: 1 day

Ultrasound scanning of the pennation angles of vastus lateralis (VL) and gastrocnemius medialis (GM) using B-mode ultrasonography (LOGIQ S8, GE Healthcare, USA) and a 7-15 MHz linear array transducer.

DXA: total lean body mass

时间窗: 1 day

Lean index of total lean body mass (LBM) with Hologic QDR-4500A, Hologic, Inc., Waltham, MA, USA

DXA: percentage fat mass

时间窗: 1 day

Adipose index of percentage fat mass using Hologic QDR-4500A, Hologic, Inc., Waltham, MA, USA.

Cross-sectional area ultrasound

时间窗: 1 day

Ultrasound scanning of the cross sectional area of rectus femoris (RF) using B-mode ultrasonography (LOGIQ S8, GE Healthcare, USA) and a 7-15 MHz linear array transducer.

次要结局

  • Handgrip and lateral pinch strength(1 day)
  • Physical performance test: five-time chair stand test(1 day)
  • Physical performance test: SPPB(1 day)
  • Physical performance test: gait speed(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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