Lai Zhangqi, Wang Xueqiang, Lee Seullee, Hou Xihe, Wang Lin
School of Kinesiology, Shanghai University of Sport, Shanghai, China.
Key Laboratory of Exercise and Health Sciences, Ministry of Education, Shanghai University of Sport, Shanghai, China.
Trials. 2017 Sep 20;18(1):437. doi: 10.1186/s13063-017-2170-6.
Knee osteoarthritis (KOA) is a leading cause of public disability. Neuromuscular function contributes to the development and/or progression of KOA. Whole body vibration (WBV) exercise improve the neuromuscular function of patients with neurological disorders and even that of older patients with limited exercise options. Therefore, WBV exercise may offer an efficient and alternative treatment for individuals with KOA. However, the effects of WBV training on the neuromuscular function of individuals with KOA remain unclear. Therefore, this study attempts to investigate the effect of a 12-week WBV exercise on the neuromuscular function of individuals with KOA.
METHODS/DESIGN: We will conduct a prospective, single-blind randomized controlled trial on 180 KOA patients. Participants will be randomly assigned to the WBV exercise, lower extremity resistance training, and health education groups. The WBV exercise group will participate in a 12-week WBV training. The lower extremity resistance training group will undergo a 12-week lower extremity resistance training of both lower limbs. The control group will receive health education for 12 weeks. After the intervention, the participants will be followed up for 3 months with no active intervention. Primary outcome measures will include anthropometric measurements, gait analysis during walking and stair climbing, muscle strength test of the knee and ankle, proprioception test of the knee and ankle, and neuromuscular response of the leg muscles. Secondary outcome measures will include self-reported pain and physical functional capacity, and physical performance measures. Furthermore, adverse events will be recorded and analyzed. If any participant withdraws from the trial, intention-to-treat analysis will be performed.
Important features of this trial mainly include intervention setting, outcome measure selection, and study duration. This study is intended for estimating the effect of WBV intervention on neuromuscular control outcomes. Study results may provide evidence to support the beneficial effects of WBV exercise on the physical performance and neuromuscular control of individuals with KOA to fill the research gap on the efficacy of WBV.
Chinese Clinical Trial Registry, ID: ChiCTR-IOR-16009234 . Registered on 21 September 2016.
膝关节骨关节炎（KOA）是导致公众残疾的主要原因。神经肌肉功能与KOA的发生和/或进展有关。全身振动（WBV）运动可改善神经功能障碍患者甚至运动选择有限的老年患者的神经肌肉功能。因此，WBV运动可能为KOA患者提供一种有效且替代的治疗方法。然而，WBV训练对KOA患者神经肌肉功能的影响仍不清楚。因此，本研究试图探讨为期12周的WBV运动对KOA患者神经肌肉功能的影响。
方法/设计：我们将对180例KOA患者进行一项前瞻性、单盲随机对照试验。参与者将被随机分配到WBV运动组、下肢阻力训练组和健康教育组。WBV运动组将参加为期12周的WBV训练。下肢阻力训练组将对双下肢进行为期12周的下肢阻力训练。对照组将接受为期12周的健康教育。干预后，对参与者进行3个月的随访，无积极干预措施。主要结局指标将包括人体测量、步行和爬楼梯时的步态分析、膝关节和踝关节的肌力测试、膝关节和踝关节的本体感觉测试以及腿部肌肉的神经肌肉反应。次要结局指标将包括自我报告的疼痛和身体功能能力以及身体表现指标。此外，将记录和分析不良事件。如果任何参与者退出试验，将进行意向性分析。
本试验的重要特征主要包括干预设置、结局指标选择和研究持续时间。本研究旨在评估WBV干预对神经肌肉控制结局的影响。研究结果可能为支持WBV运动对KOA患者身体表现和神经肌肉控制的有益作用提供证据，以填补WBV疗效研究的空白。
中国临床试验注册中心，注册号：ChiCTR-IOR-16009234。于2016年9月21日注册。
