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临床试验/NCT01647243
NCT01647243Unknown不适用

Effect of Preoperative Strength Training on Postoperative Quadriceps Strength and Ability of Function in Patients With Total Knee Arthroplasty in Fast Track Regi

University of Aarhus2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
70
试验地点
2
主要终点
Primary outcome: Sit-to-stand test

研究概览

简要总结

The purpose of this study is to investigate if preoperative strength training will result in faster recovery and higher level of function six weeks after total knee arthroplasty (TKA).

详细描述

Reduced strength of the quadriceps muscle is a common clinical finding in patients with Knee Osteoarthritis and this seems to play a central role in the development of the disease. The strength of the quadriceps muscle have been shown to be reduced by 20-40% as compared to age-matched healthy controls and this decrease in muscle strength have been closely associated with a reduced level of function and increase of pain. Furthermore, it has been demonstrated that the preoperative strength of the quadriceps muscle in patients undergoing TKA, is associated with the level of function one year after surgery. Compared to the level before the operation, an additional operation-induced reduction of the strength of the quadriceps muscle up to 60% as has been demonstrated. Presumably, an optimizing of the strength of the quadriceps muscle could counteract the impact of the expected postoperative loss of muscle strength to such an extent that the loss will be of less clinical significance. It is hypothesized that an optimizing of the strength of the quadriceps muscle may have a favorable effect on the postoperative rehabilitation program and shorten the period of convalescence.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • Planned TKA at the Aarhus University Hospital or Region Hospital Silkeborg,
  • Living in Aarhus Municipality,
  • Primary knee osteoarthritis or secondary osteoarthritis after meniscectomy or ligament injury

排除标准

  • Unstable blood pressure,
  • Neuromuscular or neurodegenerative disease,
  • Comprehension or dementia problems

结局指标

主要结局

Primary outcome: Sit-to-stand test

时间窗: Change from Baseline 6 weeks preoperative in Sit-to-Stand at 6 weeks postoperative

Ability of function test

次要结局

  • Isokinetic: Quadriceps 60 gr./sek(6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation)
  • Isokinetic: Hamstrings 60 gr./sek(6 weeks and 1 week before the operation, 1 week, 6 weeks 12 weeks and 1 year after the operation)
  • Isometric: Quadriceps (70 gr. flexion)(6 weeks and 1 week before the operation and 11 week, 6 weeks, 12 weeks and 1 year after the operation)
  • Isometric: Hamstrings (20 gr. flexion)(6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation)
  • Rate of force development (flexion and extension)(6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation)
  • Timed Up and Go(6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation)
  • 10 meter walk test(6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation)
  • 6 minute walk test(6 weeks and 1 week before operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation)
  • Knee injury and Osteoarthritis Outcome Score (KOOS)(6 weeks and 1 week before operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation)
  • Oxford Knee Score (OKS)(6 weeks before the operation and 6 weeks after)
  • EuroQol-5 dimensions (EQ-5D)(6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation)
  • Short-Form Health Survey (SF 12)(6 weeks before the operation and 1 year after)
  • Background data questionnaire(6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation)
  • Range of motion of the knee(6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation)
  • Body mass index(6 weeks and 1 week before the operation, 1 week, 6 weeks, 12 weeks and 1 year after the operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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