Doiron-Cadrin Patrick, Kairy Dahlia, Vendittoli Pascal-André, Lowry Véronique, Poitras Stéphane, Desmeules François
School of Rehabilitation, Faculty of Medicine, University of Montreal, C.P. 6128, succursale Centre-ville, Montréal, Québec H3C 3J7, Canada.
Orthopaedic Clinical Research Unit, Maisonneuve-Rosemont Hospital Research Center, University of Montreal, 5415, boulevard de l'Assomption, Montréal, Québec H1T 2M4, Canada.
Contemp Clin Trials Commun. 2016 Oct 5;4:192-198. doi: 10.1016/j.conctc.2016.10.001. eCollection 2016 Dec 15.
The accessibility for total joint arthroplasty often comes up against long wait lists, and may lead to deleterious effects for the awaiting patients. This pilot single blind randomized controlled trial aims to evaluate the impact of a telerehabilitation prehabilitation program before a hip or knee arthroplasty compared to in-person prehabilitation or to usual wait for surgery.
METHODS/DESIGN: Thirty-six patients on a wait list for a total hip or knee arthroplasty will be recruited and randomly assigned to one of three groups. The in-person prehabilitation group (n = 12) will receive a 12-week rehabilitation program (2 sessions/week) including education, exercises of the lower limb and cardiovascular training. Patients in the tele-prehabilitation group (n = 12) will receive the same intervention using a telecommunication software. The control group (n = 12) will be provided with the hospital's usual documentation before surgery. The Lower Extremity Functional Scale (LEFS) will be the primary outcome measure taken at baseline and at 12 weeks. Secondary measures will include self-reported function and quality of life as well as performance tests. A mixed-model, 2-way repeated-measure ANOVA will be used to analyse the effects of the rehabilitation programs.
This pilot study is the first to evaluate the feasibility and the impact of a telerehabilitation prehabilitation program for patients awaiting a total joint arthroplasty. The results of this pilot-RCT will set the foundations for further research in the fields of rehabilitation and tele-medicine for patients suffering from lower limb osteoarthritis.
ClinicalTrials.gov: NCT02636751.
全关节置换术的可及性常常面临漫长的等待名单,这可能会给等待手术的患者带来有害影响。这项单盲随机对照试验旨在评估与面对面的术前康复或常规等待手术相比,髋关节或膝关节置换术前远程康复预康复计划的影响。
方法/设计:将招募36名等待全髋关节或膝关节置换术的患者,并随机分配到三组中的一组。面对面预康复组(n = 12)将接受为期12周的康复计划(每周2次),包括教育、下肢锻炼和心血管训练。远程预康复组(n = 12)将使用电信软件接受相同的干预。对照组(n = 12)将在手术前获得医院的常规资料。下肢功能量表(LEFS)将作为基线和12周时的主要结局指标。次要指标将包括自我报告的功能和生活质量以及性能测试。将使用混合模型双向重复测量方差分析来分析康复计划的效果。
这项试点研究首次评估了针对等待全关节置换术患者的远程康复预康复计划的可行性和影响。这项试点随机对照试验的结果将为下肢骨关节炎患者康复和远程医疗领域的进一步研究奠定基础。
ClinicalTrials.gov:NCT02636751。