Department of Physical and Occupational Therapy, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Bispebjerg Bakke 23, Nielsine Nielsens Vej 10, Building 10, 2400, Copenhagen, NV, Denmark.
Institute of Sports Medicine Copenhagen, Department of Orthopedic Surgery, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Bispebjerg Bakke 23, Nielsine Nielsens Vej 8, Building 8, 2400, Copenhagen, NV, Denmark.
Trials. 2022 Aug 13;23(1):647. doi: 10.1186/s13063-022-06610-4.
Total hip arthroplasty is considered an efficacious procedure for relieving pain and disability, but despite that objectively measured physical activity level remains unchanged compared to pre-surgery and is still considerably lower than that of a healthy age- and sex-matched population 6-12 months post-surgery. Since there is a graded relationship between physical activity level and functional performance, increasing physical activity may enhance the outcome of the procedure. This study aims to investigate whether promotion and support of physical activity initiated 3 months after total hip arthroplasty complementary to usual rehabilitation care can increase objective measured physical activity 6 months post-surgery.
The trial is designed as a pragmatic, parallel group, two-arm, assessor-blinded, superiority, randomized (1:1), controlled trial with post intervention follow-up 6 and 12 months after total hip arthroplasty. Home-dwelling, independent, and self-reliant patients with hip osteoarthritis are provisionally enrolled prior to surgery and re-screened about 2-3 months post-surgery to confirm eligibility. Baseline assessment is conducted 3 months post-surgery. Subsequently, patients (n=200) are randomized to either a 3-month, multimodal physical activity promotion/education intervention or control (no further attention). The intervention consists of face-to-face and telephone counselling, patient education material, pedometer, and step-counting journal. The primary outcome is objectively measured physical activity, specifically the proportion of patients that complete on average ≥8000 steps per day 6 months post-surgery. Secondary outcomes include core outcomes (i.e., physical function, pain, and patient global assessment) and health-related quality of life. Furthermore, we will explore the effect of the intervention on self-efficacy and outcome expectations (i.e., tertiary outcomes).
By investigating the effectiveness of a pedometer-driven, face-to-face, and telephone-assisted counselling, behavior change intervention in complementary to usual rehabilitation, we hope to deliver applicable and generalizable knowledge to support physical activity after total hip arthroplasty and potentially enhance the outcome of the procedure.
www.
gov NCT04471532 . Registered on July 15, 2020.
全髋关节置换术被认为是一种有效缓解疼痛和功能障碍的方法，但尽管如此，与术前相比，术后患者的客观测量身体活动水平保持不变，且仍明显低于术后 6-12 个月健康年龄和性别匹配人群的水平。由于身体活动水平与功能表现之间存在分级关系，因此增加身体活动量可能会增强手术效果。本研究旨在调查全髋关节置换术后 3 个月开始，在常规康复治疗的基础上，补充促进和支持身体活动能否增加术后 6 个月的客观测量身体活动量。
该试验设计为一项实用的、平行组、两臂、评估者盲法、优效性、随机（1:1）对照临床试验，在全髋关节置换术后 6 个月和 12 个月进行干预后随访。术前筛选居家、独立和自理的髋骨关节炎患者，并在术后约 2-3 个月再次筛查以确认是否符合入选标准。在术后 3 个月进行基线评估。随后，将（n=200）名患者随机分为 3 个月的多模式身体活动促进/教育干预组或对照组（不再给予关注）。干预措施包括面对面和电话咨询、患者教育材料、计步器和计步日记。主要结局是客观测量的身体活动量，具体为术后 6 个月平均完成≥8000 步的患者比例。次要结局包括核心结局（即身体功能、疼痛和患者总体评估）和健康相关生活质量。此外，我们还将探讨干预措施对自我效能和结果预期的影响（即三级结局）。
通过调查基于计步器、面对面和电话辅助咨询的、促进身体活动的行为改变干预措施的有效性，我们希望为全髋关节置换术后的身体活动提供适用且可推广的知识，从而增强手术效果。
www.。
gov NCT04471532。于 2020 年 7 月 15 日注册。
