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临床试验/NCT03582982
NCT03582982Unknown不适用

Flywheel Resistance Exercise to Improve Skeletal Muscle 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 20 人开始时间: 2018年5月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
2
主要终点
Change in Isokinetic and isometric peak knee extension force at 12 weeks

研究概览

简要总结

Among Veterans, the prevalence of chronic kidney disease (CKD) is reported to be as high as 47.3% and a third higher than the general population. Muscle wasting and dysfunction have been identified as primary consequences of CKD. Disease-induced reductions in lean tissue adversely affect muscle fatigability. Consequently, muscle fatigability may serve as a potential limiting factor that contributes to activity limitations. However, there is a lack of evidence informing our understanding of muscle fatigability in patients with CKD. Dialysis treatment is a major factor contributing to the high financial costs of CKD care. Thus, in addition to potential health and quality of life benefits, treatments capable of maintaining kidney function or delaying the onset of dialysis treatment would provide substantial socio-economic benefit. Both lean body mass and muscle fatigability may be improved through strength training. Eccentric-overload (i.e. muscle lengthening) progressive resistance exercise (PRE) has been shown to be safe and effective for a variety of chronic conditions. Eccentric PRE using portable flywheel technology may provide a clinically viable treatment option to combat muscle impairments in CKD given the cost effectiveness and minimal space requirements for this mode of exercise.

The purpose of this study is to assess feasibility of the eccentric-overload PRE regimen for Veterans with CKD stage 3 & 4 predialysis using a prospective single-arm pre-test post-test intervention design. The primary aim of the project is to determine the effects of eccentric-overload PRE on muscle fatigability in Veterans with CKD Stages 3 & 4 predialysis. Feasibility of the regimen will be determined by the time needed to complete the 4-exercise regimen and the perceived exertion levels reported by the study participants.

研究设计

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

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

入选标准

  • ambulatory patients (with or without a gait aid)
  • CKD stage 3 or 4
  • patients receiving care at the DC VAMC Renal Service
  • the ability to speak and read English
  • orientation to person, place, and time

排除标准

  • unable to speak English
  • acute renal failure
  • unable to follow study instructions
  • any uncontrolled cardiovascular or musculoskeletal problems that would make participation in this study unsafe

研究组 & 干预措施

Eccentric overload exercise

Experimental

干预措施: Eccentric overload exercise (Behavioral)

结局指标

主要结局

Change in Isokinetic and isometric peak knee extension force at 12 weeks

时间窗: Baseline, Week 6, Week 12

Unilateral peak knee extension/flexion isokinetic force (at 180º/s and 60º/s) will be obtained across five continuous repetitions using a load cell

Change in Lean Body Mass, as estimated by diagnostic ultrasound at 12 weeks

时间窗: Baseline, Week 6, Week 12

Sonographic estimates of LBM (aggregate muscle thickness, cm) will serve as a proxy measure for muscle tissue composition in this study

Change in myosteatosis, as estimated by diagnostic ultrasound at 12 weeks

时间窗: Baseline, Week 6, Week 12

Sonographic estimates of myosteatosis (grayscale, or GSL, values, 0-255) will serve as a proxy measure for muscle tissue composition in this study

Change in Short Physical Performance Battery at 12 weeks

时间窗: Baseline, Week 12

This composite score is made up of measures of balance, gait speed (15 ft), and timed chair stands (x5).

Change in Timed Up-and-Go at 12 weeks

时间窗: Baseline, Week 12

This test will begin the test with the subject fully sitting in a chair with arm rests, with the upright mobility portion of the test focused on an easily visible marked target 3 meters away from the chair

Change in Knee extensor isokinetic muscle fatigability index at 12 weeks

时间窗: Baseline, Week 12

Knee extensor muscle fatigability will be assessed using a protocol consisting of 30 repetitions or to failure, whichever comes first, at their maximum strength

Change in Muscle blood flow at 12 weeks

时间窗: Baseline, Week 12

Blood flow will be assessed using Doppler ultrasound

次要结局

  • Change in Activities-Specific Balance Confidence (ABC) Scale at 12 weeks(Baseline, Week 12)
  • Change in weight at 12 weeks(Baseline, Week 6, Week 12)
  • Change in height at 12 weeks(Baseline, Week 6, Week 12)
  • Change in body water at 12 weeks(Baseline, Week 6, Week 12)
  • Change in Blood Pressure at 12 weeks(Baseline, Week 12)
  • Change in Grip strength at 12 weeks(Baseline, Week 12)
  • Change in Short Form Health Survey (SF-36) Scale at 12 weeks(Baseline, Week 12)
  • Change in Falls Efficacy Scale (FES) at 12 weeks(Baseline, Week 12)

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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