针对骨质疏松症和椎体骨折患者的物理治疗运动康复及个性化运动依从性支持：一项随机对照试验方案 - 骨质疏松症个体化运动依从性干预（OPTIN）研究。
Physiotherapy exercise rehabilitation with tailored exercise adherence support for people with osteoporosis and vertebral fractures: protocol for a randomised controlled trial - the OsteoPorosis Tailored exercise adherence INtervention (OPTIN) study.
机构信息
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
Physiotherapy Research Unit, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
出版信息
BMJ Open. 2022 Sep 17;12(9):e064637. doi: 10.1136/bmjopen-2022-064637.
INTRODUCTION
Vertebral fragility fractures affect at least 20% of the older population in the UK. Best practice guidelines recommend the use of exercise to slow the rate of bone loss, to maintain muscle strength and physical function, and to prevent falls and further fractures. However, treatment effects are often small and difficult to sustain and adherence, or the extent to which patients engage in treatment, has been identified as an important issue by many studies. Our hypothesis is that integrating adherence intervention strategies with an exercise intervention will be beneficial. We will compare physiotherapy exercise rehabilitation with adherence support versus physiotherapy exercise rehabilitation alone in terms of effects on (A) physical function, quality of life and fear of falling and (B) exercise self-efficacy and adherence.
METHODS AND ANALYSIS
A multicentre, two-arm, parallel group, superiority randomised controlled trial with blinded assessments at baseline (0) and 4, 8 and 12 months, with a nested qualitative study and health economic analysis. 116 participants will be allocated to either (1) outpatient physiotherapy which will include a musculoskeletal assessment and treatment including balance, posture, strength training and low impact weight-bearing exercises over 16 weeks or (2) OsteoPorosis Tailored exercise adherence INtervention intervention. This includes standard physiotherapy as above plus an additional, integrated assessment interview (30 min) and 60 min of adherence support spread over the subsequent 16 weeks.
ETHICS AND DISSEMINATION
The study protocol was approved by West of Scotland Research Ethics Committee 4 (21/WS/0071). Trial registration number ISRCTN 14465704. The paper is based on Protocol V.4.
TRIAL REGISTRATION NUMBER
ISRCTN 14465704.
简介
在英国，至少有 20%的老年人患有脊椎脆弱性骨折。最佳实践指南建议使用运动来减缓骨质流失的速度，保持肌肉力量和身体功能，并预防跌倒和进一步骨折。然而，治疗效果往往很小，难以维持，而且许多研究都认为，患者的依从性或参与治疗的程度是一个重要问题。我们的假设是，将依从性干预策略与运动干预相结合将是有益的。我们将比较物理治疗运动康复与依从性支持与单纯物理治疗运动康复在以下方面的效果：（A）身体功能、生活质量和跌倒恐惧；（B）运动自我效能和依从性。
方法和分析
这是一项多中心、两臂、平行组、优效性随机对照试验，在基线（0）和 4、8 和 12 个月进行盲法评估，并进行了嵌套的定性研究和健康经济分析。116 名参与者将被分配到以下两组之一：（1）门诊物理治疗，包括肌肉骨骼评估和治疗，包括平衡、姿势、力量训练和低冲击负重运动，持续 16 周；（2）骨质疏松症个体化运动依从性干预。这包括标准的物理治疗，外加额外的、综合评估访谈（30 分钟）和随后 16 周内的 60 分钟依从性支持。
伦理和传播
该研究方案已获得苏格兰西部研究伦理委员会 4 号（21/WS/0071）的批准。试验注册编号 ISRCTN 14465704。本文基于协议 V.4。
试验注册编号
ISRCTN 14465704。
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