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临床试验/NCT02281877
NCT02281877已完成不适用

Alterations in Skeletal Muscle Gene Expression Following Total Knee Arthroplasty

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Catabolic gene expression

研究概览

简要总结

The overall goals of this work are: 1) to elucidate alterations in gene expression and downstream protein synthesis 2 weeks after Total Knee Arthroplasty (TKA) to better explain quadriceps muscle atrophy after TKA and 2) understand the mechanisms responsible for improved maintenance of muscle strength with Neuromuscular Electrical Stimulation (NMES) utilization. Furthermore, this investigation seeks to expand previous findings regarding attenuation of strength and functional performance deficits with NMES application to better understand how altered gene expression influences muscle function.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •50 to 75 years of age
  • •Scheduled for unilateral TKA at University of Colorado Hospital
  • •Diagnosed with osteoarthritis
  • •Cognitive status that allows patients to consistently comprehend and repeat back directions regarding the details of the study

排除标准

  • •Neurological, vascular or cardiac problems that significantly limit function
  • •BMI > 35
  • •Testosterone supplementation
  • •Pregnancy
  • •Anticoagulant therapy

研究组 & 干预措施

Neuromuscular Electrical Stimulation

Experimental

Neuromuscular Electrical Stimulation (NMES) 48 hours after TKA, 5x/week, 2x/day, for 45 minutes/session.

Standard Rehabilitation Protocol

干预措施: Neuromuscular electrical stimulation (NMES) (Procedure)

Neuromuscular Electrical Stimulation

Experimental

Neuromuscular Electrical Stimulation (NMES) 48 hours after TKA, 5x/week, 2x/day, for 45 minutes/session.

Standard Rehabilitation Protocol

干预措施: Standard Rehabilitation Protocol (Behavioral)

Control

Active Comparator

Standard Rehabilitation Protocol

干预措施: Standard Rehabilitation Protocol (Behavioral)

结局指标

主要结局

Catabolic gene expression

时间窗: Change in gene expression from immediately pre surgery to 2 weeks after surgery

Standard procedures including total RNA isolation, cDNA synthesis, cRNA labeling, microarray hybridization and image acquisition will be performed. Protein content (translation of MAFbx, MuRF1, myostatin) will be analyzed. Total RNA (500 ng) will be reverse transcribed with the iScript cDNA synthesis kit (Bio-Rad, Hercules, CA), and quantitative PCR will be performed using primer sets for genes of interest, reference genes and iQ SYBR Supermix (Bio-Rad) following manufacturer's protocols.

次要结局

  • Changes in quadriceps strength(3 days Pre operative and 2 weeks post operative)
  • Changes in quadriceps size(3 days Pre operative and 2 weeks post operative)
  • Muscle Fiber Cross-Sectional Area(Immediately pre surgery to 2 weeks after surgery)
  • Changes in neural cell adhesion molecule (NCAM) concentration(Preop and 2 weeks postop)
  • Functional Performance Measures (4 meter walk test, timed up and go, stair climbing test)(3 days Pre operative and 2 weeks post operative)
  • Anabolic Gene Expression(Immediately pre surgery to 2 weeks after surgery)
  • Changes in quadriceps activation(3 days Pre operative and 2 weeks post operative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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