General Hospital Novo Mesto, Novo mesto, Slovenia.
Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
Trials. 2022 Nov 8;23(1):929. doi: 10.1186/s13063-022-06779-8.
Total hip arthroplasty (THA) is very effective in alleviating pain, but functional deficits persist up to a year following surgery. Regardless of standard physiotherapy programs, significant additional muscular atrophy and weakness occur. Deficits in strength have serious adverse consequences for these patients with respect to physical function, the maintenance of independence, and the requirement for revision surgery. Progressive resistance training in rehabilitation following THA has been shown to significantly enhance muscle strength and function. The fundamental principle is to progressively overload the exercised muscle as it becomes stronger. Different strength training protocols have been used at different times in the postoperative phase, in group or individual practices, with major differences being in center-based and home-based programs with or without supervision. The primary objective of our study is to evaluate whether an early postoperative home-based strength training protocol can improve patient functional outcomes at 3 months and 1 year following surgery. Secondary objectives are the feasibility of the presented protocol for all elective THA patients and its safety.
METHODS/DESIGN: This study is a prospective multicenter randomized clinical trial to be conducted in the orthopedic departments of two Slovenian hospitals. In each hospital, 124 patients aged 60 or older with unilateral osteoarthritis, an ASA score between 1 and 3, a signed informed consent form, and no terminal illness disabling rehabilitation participation will be randomly assigned to the intervention or control group. THA with an anterior approach will be performed. All patients will receive current standard physiotherapy during hospitalization. Patients in the intervention group will also learn strength and sensory-motor training exercises. Upon discharge, all will receive USB drives with exercise videos, written exercise instructions, and a training diary. Physiotherapists will perform the assessments (physical tests and the maximal voluntary isometric contraction assessment), and patients will fill out outcome assessment questionnaires (the Harris Hip Score and 36-Item Short Form Health Survey) at baseline and 1, 3, and 12 months after surgery.
The main purpose of our study is to design a new standardized rehabilitation protocol with videos that will be effective, safe, and accessible to all Slovenian THA patients.
ClinicalTrials.gov NCT04061993 . Registered on 07 November 2019. Protocol ID: PRT_PhD. Version 1.
全髋关节置换术（THA）在缓解疼痛方面非常有效，但手术后长达一年仍存在功能缺陷。无论是否进行标准的物理治疗方案，都会出现明显的额外肌肉萎缩和无力。这些患者的力量缺陷对其身体功能、独立性的维持以及需要进行翻修手术有严重的不良影响。THA 后的康复渐进性抗阻训练已被证明可显著增强肌肉力量和功能。其基本原理是随着所锻炼肌肉的增强逐渐增加其负荷。在术后阶段的不同时间，在小组或个人实践中，已经使用了不同的力量训练方案，主要区别在于有无监督的中心和家庭方案。我们研究的主要目的是评估术后早期家庭为基础的力量训练方案是否可以改善手术后 3 个月和 1 年的患者功能结果。次要目标是评估该方案对所有择期 THA 患者的可行性及其安全性。
方法/设计：这是一项在斯洛文尼亚两家医院的骨科部门进行的前瞻性多中心随机临床试验。在每家医院，将 124 名年龄在 60 岁或以上的单侧骨关节炎患者、ASA 评分在 1 至 3 之间、签署了知情同意书且无导致无法参与康复的终末期疾病的患者随机分配到干预组或对照组。将进行前路髋关节置换术。所有患者在住院期间将接受当前标准的物理治疗。干预组的患者还将学习力量和感觉运动训练练习。出院后，所有患者都将收到带有运动视频、书面运动说明和训练日记的 USB 驱动器。物理治疗师将进行评估（物理测试和最大自主等长收缩评估），患者将在基线和手术后 1、3 和 12 个月填写结果评估问卷（髋关节 Harris 评分和 36 项简短健康调查）。
我们研究的主要目的是设计一种新的标准化康复方案，该方案具有视频功能，对所有斯洛文尼亚 THA 患者有效、安全且易于使用。
ClinicalTrials.gov NCT04061993。于 2019 年 11 月 7 日注册。方案 ID：PRT_PhD。版本 1。
