Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.
BMJ Open. 2020 Jul 19;10(7):e035014. doi: 10.1136/bmjopen-2019-035014.
While total hip replacement (THR) and total knee replacement (TKR) successfully reduce pain associated with chronic joint pathology, this infrequently translates into increased physical activity. This is a challenge given that over 50% of individuals who undergo these operations are physically inactive and have medical comorbidities such as hypertension, heart disease, diabetes and depression. The impact of these diseases can be reduced with physical activity. This trial aims to investigate the effectiveness of a behaviour change physiotherapy intervention to increase physical activity compared with usual rehabilitation after THR or TKR.
The PEP-TALK trial is a multicentre, open-labelled, pragmatic randomised controlled trial. 260 adults who are scheduled to undergo a primary unilateral THR or TKR and are moderately inactive or inactive, with comorbidities, will be recruited across eight sites in England. They will be randomised post-surgery, prior to hospital discharge, to either six, 30 min weekly group-based exercise sessions (control), or the same six weekly, group-based, exercise sessions each preceded by a 30 min cognitive behaviour approach discussion group. Participants will be followed-up to 12 months by postal questionnaire. The primary outcome is the University of California, Los Angeles (UCLA) Physical Activity Score at 12 months. Secondary outcomes include: physical function, disability, health-related quality of life, kinesiophobia, perceived pain, self-efficacy and health resource utilisation.
Research ethics committee approval was granted by the NRES Committee South Central (Oxford B - 18/SC/0423). Dissemination of results will be through peer-reviewed, scientific journals and conference presentations.
ISRCTN29770908.
全髋关节置换术(THR)和全膝关节置换术(TKR)成功减轻了慢性关节病变相关的疼痛,但这很少转化为身体活动的增加。这是一个挑战,因为超过 50%接受这些手术的人身体不活跃,并且患有高血压、心脏病、糖尿病和抑郁症等合并症。这些疾病的影响可以通过身体活动来减轻。本试验旨在研究行为改变物理治疗干预与 THR 或 TKR 后的常规康复相比,增加身体活动的效果。
PEP-TALK 试验是一项多中心、开放性、实用随机对照试验。将招募 260 名在英格兰 8 个地点计划接受初次单侧 THR 或 TKR 的成年人,他们的活动度中度不足或不足,伴有合并症。他们将在手术后、出院前随机分组,接受每周 6 次、每次 30 分钟的小组基础运动课程(对照组),或同样的每周 6 次、小组基础运动课程,每次课程前先进行 30 分钟的认知行为方法讨论小组。参与者将通过邮寄问卷进行 12 个月的随访。主要结局是 12 个月时的加利福尼亚大学洛杉矶分校(UCLA)身体活动评分。次要结局包括:身体功能、残疾、健康相关生活质量、运动恐惧症、感知疼痛、自我效能和卫生资源利用。
伦理委员会批准了国家研究伦理服务中心(牛津 B - 18/SC/0423)的研究。结果将通过同行评审的科学期刊和会议报告进行传播。
ISRCTN29770908。