术前股四头肌力量训练对全膝关节置换术前和术后即刻膝关节伸肌力量的疗效：一项随机、剂量反应试验的方案（QUADX-1 试验）。

Efficacy of pre-operative quadriceps strength training on knee-extensor strength before and shortly following total knee arthroplasty: protocol for a randomized, dose-response trial (The QUADX-1 trial).

机构信息

Physical Medicine and Rehabilitation Research - Copenhagen (PMR-C), Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.

Department of Physical and Occupational Therapy, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.

出版信息

Trials. 2018 Jan 18;19(1):47. doi: 10.1186/s13063-017-2366-9.

BACKGROUND

Patients with knee osteoarthritis (OA) report knee pain, limitation in physical activities and low quality of life. The two primary treatments for knee OA are non-surgical treatment (e.g., exercise) and surgery (total knee arthroplasty (TKA)); however, national guidelines recommend non-surgical treatment to be tried prior to surgical procedures. Patients with knee OA are characterized by decreased muscle strength, particularly in the knee-extensor muscles. Correspondingly, decreased knee-extensor strength is found to be associated with an increased risk of development, progression and severity of knee OA symptoms. Recent trials suggest a positive effect of pre-operative exercise on pre- and post-operative outcome; however, the most effective pre-operative knee-extensor strength exercise dosage is not known. The purpose of the present trial is to investigate the efficacy of three different exercise dosages of pre-operative, home-based, knee-extensor strength exercise on knee-extensor strength before and shortly after surgery in patients eligible for TKA due to end-stage knee OA.

METHODS

In this randomized dose-response trial with a three-arm parallel design, 140 patients with end-stage knee OA (candidates for TKA) are randomized to one of three exercise dosages (two, four or six session/week) of knee-extensor strength exercise (three sets, 12 repetitions at 12 RM, per exercise session) for 12 weeks. The knee-extensor strength exercise is home-based (unsupervised) and performed with an elastic exercise band following an initial exercise instruction. Adherence is objectively quantified using a sensor attached to the exercise band. The primary outcome will be the change in knee-extensor strength. Following the 12-week exercise period, the need for TKA surgery is re-assessed by an orthopedic surgeon.

DISCUSSION

Decreased knee-extensor strength is a major challenge in patients with knee OA. Exercise programs focusing on knee-extensor strength are found to be more effective in relieving knee OA pain and symptoms compared to more general exercise programs. However, the optimal exercise dosage for knee-extensor strength deficits in patients with knee OA is inconclusive. Knowledge on the dose-response relationship for knee-extensor strength exercise in patients with knee OA will help guide future non-surgical treatment in this patient population.

TRIAL REGISTRATION

ClinicalTrials.gov, ID: NCT02931058 . Pre-registered on 10 October 2016.

背景

膝骨关节炎（OA）患者会报告膝关节疼痛、身体活动受限和生活质量下降。膝 OA 的两种主要治疗方法是非手术治疗（如运动）和手术（全膝关节置换术（TKA））；然而，国家指南建议在手术前尝试非手术治疗。膝 OA 患者的特征是肌肉力量下降，尤其是膝关节伸肌。相应地，膝关节伸肌力量下降与膝 OA 症状的发展、进展和严重程度增加有关。最近的试验表明，术前运动对术前和术后结果有积极影响；然而，最有效的术前膝关节伸肌力量运动剂量尚不清楚。本试验旨在研究术前、家庭为基础、膝关节伸肌力量运动三种不同剂量对终末期膝 OA 患者 TKA 候选患者膝关节伸肌力量术前和术后短期内的疗效。

方法

在这项具有三臂平行设计的随机剂量反应试验中，140 名终末期膝 OA（TKA 候选者）患者被随机分为三组中的一组，接受三种不同剂量（每周两次、四次或六次）的膝关节伸肌力量运动（每次运动 3 组，每组 12 次，重复 12 RM），持续 12 周。膝关节伸肌力量运动是家庭（非监督），并使用弹性运动带进行，遵循初始运动指导。使用附在运动带上的传感器客观地量化依从性。主要结果将是膝关节伸肌力量的变化。12 周运动期结束后，由骨科医生重新评估 TKA 手术的需求。