Department of Physical Therapy and Department of Biomechanics and Movement Science, University of Delaware, Newark, Delaware.
Department of Physical Therapy, University of Delaware.
Phys Ther. 2018 Jul 1;98(7):578-584. doi: 10.1093/ptj/pzy037.
The definitive treatment for knee osteoarthritis is a total knee replacement, which results in a clinically meaningful improvement in pain and physical function. However, evidence suggests that physical activity (PA) remains unchanged after total knee replacement (TKR).
The objective of this study is to investigate the efficacy, fidelity, and safety of a physical therapist-administered PA intervention for people after TKR.
This study will be a randomized controlled trial.
The setting is an outpatient physical therapy clinic.
The participants are 125 individuals who are over the age of 45 and are seeking outpatient physical therapy following a unilateral TKR.
In addition to standardized physical therapy after TKR, the intervention group will receive, during physical therapy, a weekly PA intervention that includes a wearable activity tracking device, individualized step goals, and face-to-face feedback provided by a physical therapist.
The control group will receive standardized physical therapy alone after TKR.
The efficacy of the intervention will be measured as minutes per week spent in moderate to vigorous PA at enrollment, at discharge, and at 6 months and 12 months after discharge from physical therapy. The fidelity and safety of the intervention will be assessed throughout the study.
Participants will not be masked, PA data will be collected after randomization, and the trial will be conducted at a single site.
The goal of this randomized controlled trial is to increase PA after TKR. A protocol for investigating the efficacy, fidelity, and safety of a physical therapist-administered PA intervention for people after TKR is presented. The findings will be used to support a large multisite clinical trial to test the effectiveness, implementation, and cost of this intervention.
膝关节骨关节炎的确定性治疗方法是全膝关节置换术，这可显著改善疼痛和身体功能。然而，有证据表明，全膝关节置换术后（TKR）的身体活动（PA）仍保持不变。
本研究旨在探讨物理治疗师管理的 PA 干预措施对 TKR 后患者的疗效、保真度和安全性。
这是一项随机对照试验。
该研究将在门诊物理治疗诊所进行。
参与者为 125 名年龄在 45 岁以上、在接受单侧 TKR 后正在接受门诊物理治疗的个体。
除 TKR 后标准化物理治疗外，干预组还将在物理治疗期间接受每周一次的 PA 干预，其中包括可穿戴活动跟踪设备、个性化的步数目标以及由物理治疗师提供的面对面反馈。
TKR 后仅接受标准化物理治疗。
干预的疗效将通过在招募时、出院时以及出院后 6 个月和 12 个月时每周中等至剧烈 PA 所花费的分钟数来衡量。整个研究过程中，将对干预的保真度和安全性进行评估。
参与者不会被设盲，PA 数据将在随机分组后收集，并且该试验将在单一地点进行。
本随机对照试验的目标是增加 TKR 后的 PA。本文提出了一种用于研究物理治疗师管理的 PA 干预措施对 TKR 后患者疗效、保真度和安全性的方案。研究结果将用于支持一项大型多中心临床试验，以检验该干预措施的有效性、实施情况和成本。
