跳至主要内容
临床试验/NCT02903992
NCT02903992已完成不适用

SArcopenia Prevalence in Frail Older Adults: SAF Study

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2016年5月1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
225
试验地点
2
主要终点
Sarcopenia Diagnostic with Dual-energy X-ray absorptiometry

研究概览

简要总结

The age-associated loss of lean mass is a defining parameter of sarcopenia and may lead to various negative health outcomes such as impairment of physical performance and disability. Furthermore sarcopenia is considered to be one of the main factors in the pathogenesis of the frailty syndrome. However, for clinical use and for treatment and prevention strategies, reliable diagnostic criteria and cutpoints based on clinically relevant thresholds are indispensable.

This topic has recently been addressed by the Foundation for the National Institutes of Health Sarcopenia Project which identified cutpoints for appendicular lean mass (ALM) below which older adults had a higher likelihood of clinically relevant weakness reflected by low grip strength. Moreover, a low ALM-to-body mass index (BMI) ratio (<0.789 men and <0.512 women) was found to be associated with increased likelihood for mobility impairment.

In this context, the aim of this study is to study the prevalence of sarcopenia in a sample of community-dwelling frail and pre-frail older adults.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Aged 70 years and over,
  • Living independently (ADL score ≥ 5/6),
  • Fail or pre-frail according to Fried criteria,
  • Informed written consent,
  • Subjects affiliated to a social security.

排除标准

  • Robusts patients (no Fried criteria),
  • Other disorders that could interfere with the interpretation of the study (like visual or hearing impairments),
  • Subjects under justice protection,
  • Participation in another study at the same time.

结局指标

主要结局

Sarcopenia Diagnostic with Dual-energy X-ray absorptiometry

时间窗: one day (participation of subject)

The primary outcome of SAF study is to assess the prevalence of sarcopenia in frail and pre-frail older adults. The primary endpoint is the sarcopenia diagnostic. In patients with at least one Fried criteria, we would like to detect the number of patient with low lean muscle mass adjusted for body mass index \<0.789 for men and \<0.512 for women.

次要结局

  • (SPPB) score(one day (participation of subject))
  • (IADL) score(one day (participation of subject))
  • (MMSE) score(one day (participation of subject))
  • (MNA) score(one day (participation of subject))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验