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临床试验/NCT03035266
NCT03035266已完成不适用

The Effect of Blood Flow Restriction Training on Muscle Atrophy Following Knee Surgery; A Randomized Control Trial

Keller Army Community Hospital4 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年4月5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
22
试验地点
4
主要终点
Peak Torque (foot-pounds), best repetition out of 15 repetitions

研究概览

简要总结

The investigators will compare differences in quadriceps strength, leg girth, and functional outcome scores between two groups of patients after weeks 6 and 12 as well as 6 months following meniscus or articular cartilage repair/restoration requiring 6 weeks of non-weight bearing or limited weight bearing status in a brace at 0° degrees of knee extension. One group will receive BFR with standard post-operative rehabilitation for 12 weeks followed by the standard protocol progression for the remainder of the treatment program. The other group will receive standard post-operative rehabilitation without BFR for the duration of treatment program.

详细描述

The aim is to compare strength, patient reported outcomes, and functional outcomes of post-operative therapy with and without adjunctive BFR training. To accomplish this task the investigators will compare differences in thigh girth between two groups of patients after the first 6 weeks and 12 weeks as well as 6 months following meniscus or articular cartilage repair requiring 6 weeks of non-weight bearing or limited weight bearing status in a brace at 0˚ degrees of extension. In addition, isokinetic testing of the quadriceps and hamstrings will be performed at 12 weeks and 6 months post-operatively. Lower extremity girth measurements after knee surgery can be performed with good to excellent intra- and inter-rater reliability. Quadriceps strength measured with isokinetic testing is related to performance measures such as jumping. Limb circumference measurement, limb CSA measurement, and isokinetic strength testing are commonly utilized in BFR studies as outcome measures.One group will receive BFR for 12 weeks in addition to standard post-operative rehabilitation and the other group will receive standard post-operative rehabilitation without BFR.

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
Double (Investigator, Outcomes Assessor)

盲法说明

Investigators recording thigh girth and isokinetic data will be blinded to group assignment.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Military healthcare beneficiaries between the age of 18 and 50 years.
  • Must intend to remain on station at location of surgery for 6 months from date of surgery.
  • Meniscus repair or cartilage restoration technique to include microfracture, osteochondral autograft transfer system, osteochondral allograft transplantation, and autologous chondrocyte implantation following standard post-operative protocol guidelines requiring a 6 week period of non-weight bearing or limited weight bearing in a brace at 0˚ degrees of extension.

排除标准

  • Concomitant ligamentous repair/reconstruction
  • Known pregnancy
  • Any medical condition for which aerobic exercise is contraindicated
  • Additional back, hip, or knee surgery in the previous 12 months
  • History of vascular or cardiac impairment

结局指标

主要结局

Peak Torque (foot-pounds), best repetition out of 15 repetitions

时间窗: 12 weeks and 6 months post operative

Change in isokinetic peak torque knee extension and knee flexion at 180 degrees/sec and at 300 degrees/second

次要结局

  • Lower Extremity Functional Scale (LEFS) Questionnaire(baseline, 6 weeks, 12 weeks, and 6 months)
  • Thigh circumference (centimeters)(baseline, 6 weeks, 12 weeks, and 6 months)
  • Visual Analog Scale (VAS), 0 to 40 mm self report pain scale(baseline, 6 weeks, 12 weeks, and 6 months)

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

John Mason

Assistant Chief, PT

Keller Army Community Hospital

研究点 (4)

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