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临床试验/NCT04988828
NCT04988828Unknown不适用

The Effects of Whole Body Vibration Therapy on Increasing Quadriceps Strength Prior to Anterior Cruciate Ligament Reconstruction

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年3月16日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
quadriceps central activation ratio

研究概览

简要总结

Introduction: Approximately 35% patients can not return to sports after anterior cruciate ligament reconstruction(ACLR). Persistent quadriceps weakness is a factor that prevents patients return to sports. Pre-operative quadriceps strength is a predictor for the outcomes after ACLR. Therefore, enhancing pre-operative quadriceps is important. However, current prehabilitation can not well restore quadriceps strength may be due to quadricep inhibition. Whole body vibration was proposed as a promising intervention to increase muscle strength and modulate quadriceps inhibition simultaneously. Therefore, this study aim to investigate if whole body vibration has the efficacy of enhancing pre-operative quadriceps and modulating quadricep inhibition in patients with ACL injuries.

Methods: A randomized controlled trial was designed. Patients with primary ACL injuries, age from 18-45 yrs, BMI<29, physically active who awaiting ACLR will be included. Patients with any previous lower-limb injuries within 1 year, any cardiovascular or metabolic disorders will be excluded. All the subjects in this study have to finish their routine 5 week prehabilitation as well as the interventions. The primary outcomes of this study include quadriceps strength and quadriceps central activation ratio. Secondary outcomes include the score of IKDC and ACL-RSI, as well as the concentrations of myokines in serum.

详细描述

The effect of whole body vibration therapy on increasing quadriceps strength prior to anterior cruciate ligament reconstruction

  1. Introduction:

Anterior cruciate ligament (ACL) injury is a common knee injury in orthopaedic and sports medicine. It is estimated that there are 200000 ACL injuries annually in US. According to the ACL injury registry system of Scandinavia, the incidence of ACL injury was about 32-38/10000 people per year. ACL reconstruction (ACLR) has been recommended as the optimal treatment to restore knee passive laxity in patients with ACL injury who have desire to return to sports. However, a recent meta-analysis showed that only 42% of elite athletes are able to return to non-elite competitive sports following a successful reconstruction and rehabilitation. About 50% of them cannot return to sports at 1 year and one-third cannot return at 2 years post-operatively.

Until now, the reason why some patients can have good functional recovery following surgery while the others cannot is still unknown. Since the ultimate goal of ACL reconstruction is to help patients return to pre-injury activity without high re-injury risk, identifying those who are at high risk of poor recovery following surgery is extremely essential. Some previous studies concluded that pre-operative quadriceps strength is a key predictor for functional recovery post-operatively. Therefore, increasing pre-operative quadriceps strength is very important. Several studies implemented pre-operative rehabilitation found that part of patients still could not achieve symmetrical quadriceps strength, which mainly because of injury-induced arthrogenic inhibition and increased atrophy-related biomarkers makes those patients have low response to traditional strength training.

It has been demonstrated that whole body vibration is an effective way in decreasing AMI due to increase corticomotor excitability. Whole body vibration becomes more and more popular as an additional program of physiotherapy for diverse disorders. For patients with ACL injury, previous studies indicate that whole body vibration is effective in improving quadriceps function, neuromuscular control and balance. There are several mechanisms can explain the benefits whole body vibration therapy brought to ACLD patients. Firstly, vibratory stimuli can increase the excitability of type Ia afferent neuron via muscle spindles, resulting in tonic vibration reflex and enlargement of type I and type II muscle fibers. Secondly, whole body vibration can decrease fast-twitch motor unit recruitment thresholds immediately, leading to higher activation of muscles. Thirdly, vibratory stimuli may activate proprioceptive receptors of lower limbs. On molecular level, Low-amplitude high frequency vibration can down regulate Atrogin-1 mRNA and myostatin expression. In addition, it also was found effective in increasing circulating irisin which is a recently identified myokine levels acutely after vibration exercises. Several studies also reported that whole body vibration training can reduce blood concentration of TNF-αreceptors, TNF-α, IL-6 in elderly population and healthy people after exercise. Based on the above, whole body vibration maybe a more efficient and effective way to improve quadriceps strength prior to surgery.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • ACL injuries
  • no previous lower limb injury within 1 year
  • physically active before the injury

排除标准

  • have any cardiovascular
  • nervous or metabolic disorders

结局指标

主要结局

quadriceps central activation ratio

时间窗: change from baseline to finishing the intervention

he peak torque recorded from the MVIC test will be inputted into a software to deliver a supramaximal electrical stimulus (from DS7R:10-pulses, 100 Hz train) to the quadriceps muscle once the maximal knee extension torque is reached. The electrical stimulus will be delivered through two self-adhesive stimulating electrodes (8 × 13cm) applied over the vastus lateralis muscle proximally and the vastus medialis distally. Quadriceps activation ratio will be calculated using the central activation ratio formula (CAR), which is (MVIC) / (peak torque generated by the stimulus) \*100. A CAR of 100 was used to represent complete quadriceps activation. CAR values that were ≥ 95 were considered to be 'normal' and/or representative of a healthy CAR value. The maximal CAR value that is collected will be used for statistical analysis.

quadriceps strength

时间窗: change from baseline to finishing the intervention

Subjects' quadriceps peak torque (both legs) measurement will be completed on an isokinetic strength dynamometer (Biodex System 3, Biodex Medical Systems, Shirley, NY, USA). During the test, subjects are positioned with their hip flexed 90°and knee flexed 30°and subjects are asked to try their very best to ensure the MVIC. Meanwhile, the tester will give encouraging word 'harder and harder' during the process of contraction. The MVIC test will repeat 3 times per subject. And sufficient rest is allowed during the interval of each repeat. In order to standardize the data, individual MVIC peak torque will be divided by the body mass of every subject for the further statistic analysis.

次要结局

  • International Knee Documentation Committee Subjective Knee Form (IKDC)(change from baseline to finishing the intervention)
  • Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)(change from baseline to finishing the intervention)
  • International Physical Activity Questionnaire - Short Form (IPAQ)(Every week during the 5 week interventions)

研究者

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

Jihong Qiu

PrincipL Investigator

Chinese University of Hong Kong

研究点 (2)

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