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远程医疗提供的临床医生支持的运动和减肥计划对髋骨关节炎的有效性 - Better Hip 随机对照试验方案。

Effectiveness of a telehealth-delivered clinician-supported exercise and weight loss program for hip osteoarthritis - protocol for the Better Hip randomised controlled trial.

机构信息

Centre for Health, Exercise and Sports Medicine, Department of Physiotherapy, The University of Melbourne, Vic, Melbourne, Australia.

Medibank Private, Vic, Melbourne, Australia.

出版信息

BMC Musculoskelet Disord. 2024 Feb 13;25(1):138. doi: 10.1186/s12891-023-07131-0.

Abstract

BACKGROUND

Hip osteoarthritis (OA) is a leading cause of chronic pain and disability worldwide. Self-management is vital with education, exercise and weight loss core recommended treatments. However, evidence-practice gaps exist, and service models that increase patient accessibility to clinicians who can support lifestyle management are needed. The primary aim of this study is to determine the effectiveness of a telehealth-delivered clinician-supported exercise and weight loss program (Better Hip) on the primary outcomes of hip pain on walking and physical function at 6 months, compared with an information-only control for people with hip OA.

METHODS

A two-arm, parallel-design, superiority pragmatic randomised controlled trial. 212 members from a health insurance fund aged 45 years and over, with painful hip OA will be recruited. Participants will be randomly allocated to receive: i) Better Hip; or ii) web-based information only (control). Participants randomised to the Better Hip program will have six videoconferencing physiotherapist consultations for education about OA, prescription of individualised home-based strengthening and physical activity programs, behaviour change support, and facilitation of other self-management strategies. Those with a body mass index > 27 kg/m, aged < 80 years and no specific health conditions, will also be offered six videoconferencing dietitian consultations to undertake a weight loss program. Participants in the control group will be provided with similar educational information about managing hip OA via a custom website. All participants will be reassessed at 6 and 12 months. Primary outcomes are hip pain on walking and physical function. Secondary outcomes include measures of pain; hip function; weight; health-related quality of life; physical activity levels; global change in hip problem; willingness to undergo hip replacement surgery; rates of hip replacement; and use of oral pain medications. A health economic evaluation at 12 months will be conducted and reported separately.

DISCUSSION

Findings will determine whether a telehealth-delivered clinician-supported lifestyle management program including education, exercise/physical activity and, for those with overweight or obesity, weight loss, is more effective than information only in people with hip OA. Results will inform the implementation of such programs to increase access to core recommended treatments.

TRIAL REGISTRATION

Australia New Zealand Clinical Trials Registry (ACTRN12622000461796).

摘要

背景

髋骨关节炎(OA)是全球范围内导致慢性疼痛和残疾的主要原因。自我管理至关重要,教育、锻炼和减肥是核心推荐的治疗方法。然而,实践与证据之间存在差距,需要建立能够增加患者与支持生活方式管理的临床医生接触机会的服务模式。本研究的主要目的是确定远程医疗提供的临床医生支持的锻炼和减肥计划(Better Hip)在 6 个月时对髋痛和身体功能的主要结果的有效性,与髋 OA 患者的仅信息对照组相比。

方法

这是一项双臂、平行设计、优势实用性随机对照试验。将从一家健康保险公司招募 212 名年龄在 45 岁及以上、患有疼痛性髋 OA 的成员。参与者将被随机分配接受以下治疗之一:i)Better Hip;或 ii)仅基于网络的信息(对照组)。随机分配到 Better Hip 计划的参与者将接受六次视频会议物理治疗师咨询,以接受有关 OA 的教育、个性化家庭强化和体育活动方案的处方、行为改变支持以及促进其他自我管理策略。对于 BMI>27kg/m2、年龄<80 岁且无特殊健康状况的人,还将提供六次视频会议营养师咨询,以进行减肥计划。对照组的参与者将通过一个定制网站获得关于管理髋 OA 的类似教育信息。所有参与者将在 6 个月和 12 个月时进行重新评估。主要结果是步行时的髋痛和身体功能。次要结果包括疼痛测量;髋关节功能;体重;健康相关生活质量;身体活动水平;髋关节问题的整体变化;愿意接受髋关节置换手术;髋关节置换率;以及口服止痛药的使用。将在 12 个月时进行健康经济学评估,并单独报告。

讨论

研究结果将确定远程医疗提供的临床医生支持的生活方式管理计划(包括教育、锻炼/体育活动,以及对于超重或肥胖者,还包括减肥)是否比髋 OA 患者的单纯信息更有效。研究结果将为实施此类计划以增加对核心推荐治疗方法的获取提供信息。

试验注册

澳大利亚新西兰临床试验注册(ACTRN12622000461796)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0b9b/10863299/3dbf3ffed68f/12891_2023_7131_Fig1_HTML.jpg

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