跳至主要内容
临床试验/NCT03160326
NCT03160326Unknown不适用

The Quantitative Ultrasound Assessment of Lean and Intramuscular Adipose Tissue in Veterans With Chronic Kidney Disease

Washington D.C. Veterans Affairs Medical Center2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
75
试验地点
2
主要终点
Lean Body Mass

研究概览

简要总结

Currently there is no standard way to detect age-related skeletal muscle loss in patients with chronic kidney disease. Investigators are working on finding rapid and inexpensive ways to measure muscle size and fat within the muscle.

详细描述

The accelerated muscle wasting associated with chronic kidney disease (CKD) is a source of morbidity and an increased incidence of bone fracture secondary to falls. However, sarcopenia secondary to CKD is not routinely screened or assessed in this patient population. This protocol, "Quantitative Ultrasound Assessment of Lean and Intramuscular Adipose Tissue in Veterans Project" (i.e., QUALITY VETS) is a VA Center for Innovation (VACI) funded pilot study with the purpose of using a clinically viable sarcopenia screening approach for Veterans with CKD who are currently receiving care at the Renal Service.

The investigative team will screen and assess diminished muscle mass, quality, and performance in Veterans with CKD (Stage 3 and 4), and also examine the relationship between the muscle characteristics and estimated fall risk within the sample. Key outcome measures will be obtained within the domains of muscle performance (peak grip strength), functional status (Short Physical Performance Battery), estimates of tissue/body composition (diagnostic ultrasound and DXA), and fall risk (Timed Up-and-Go test). Secondary measures will include questionnaires regarding of fall avoidance, physical activity, depression, and quality of life (QoL).

The general analysis approach will be to characterize the proportion of participants with: sarcopenia based on the European Working Group on Sarcopenia in Older People (EWGSOP) algorithm, low muscle quality based on preliminary echogenicity cut off values and criterion strength values, and an elevated risk of falling based on the Timed Up-and-Go age-dependent cut off values. Investigators will determine the magnitude of association between the skeletal muscle outcomes and fall risk within the participant sample. Hazard ratios will be used to estimate the impact of the sarcopenia classification and echogenicity values on the positive classification of fall risk.

The optimal treatment of Veterans with CKD who have an elevated risk of falls may be enhanced by the timely identification of accelerated muscle changes. The QUALITY-VETS Project will help to determine appropriate screening and assessment strategies that could be implemented in subsequent longitudinal studies involving exercise interventions and fall prevention training.

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
18 Years 至 84 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Ambulatory patients (with or without a gait aid)
  • •18-84.9 years of age with CKD stage 3 or 4
  • •Receiving care at the DC or SF VA Medical Center Renal Service
  • •Able to speak and read English
  • •Orientation to person, place, and time

排除标准

  • •Acute renal failure
  • •Pregnancy
  • •Any uncontrolled cardiovascular or musculoskeletal disease that, in the opinion of the principal investigator, could make participation unsafe
  • •Body size exceeds the dimensional limits of the DXA scanner

结局指标

主要结局

Lean Body Mass

时间窗: day 1

Dual Energy X-ray Absorptiometry (DXA) scan (kg/m2)

Timed Up-and-Go

时间窗: day 1

Performance-based fall risk assessment

Short Physical Performance Battery

时间窗: day 1

Performance-based functional assessment battery; scores range from 0 (worst performance) to 12 (best performance)

Muscle Quality

时间窗: day 1

Muscle measurements at 6 sites using diagnostic ultrasound (grayscale levels, 0-255)

Grip Strength

时间窗: day 1

Measured using a dynamometer (kg)

次要结局

  • Falls Efficacy Scale(day 1)
  • Sarcopenia-specific QoL scale (SarQoL)(day 1)
  • Hip/waist circumference(day 1)
  • Activities-Specific Balance Confidence Scale(day 1)
  • Height(day 1)
  • Weight(day 1)
  • SF-36 - Physical Function Scale(day 1)
  • Body composition(day 1)
  • Isometric peak knee extension force(day 1)
  • Physical Activity Scale for the Elderly(day 1)
  • CES-D(day 1)

研究者

发起方
Washington D.C. Veterans Affairs Medical Center
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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