CycLing and EducATion (CLEAT): protocol for a single centre randomised controlled trial of a cycling and education intervention versus standard physiotherapy care for the treatment of hip osteoarthritis.
CycLing and EducATion (CLEAT): protocol for a single centre randomised controlled trial of a cycling and education intervention versus standard physiotherapy care for the treatment of hip osteoarthritis.
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DOI：
10.1186/s12891-023-06456-0
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发表时间：
2023-05-03
影响因子：
2.3
通讯作者：
中科院分区：
文献类型：
--
作者：
骨关节炎(OA)是一种慢性退行性关节疾病，目前尚无治愈方法。对于轻至中度髋关节骨性关节炎患者的非手术治疗主要侧重于通过国家健康与护理卓越研究所(NICE)建议的教育和建议、锻炼以及适当的减肥相结合来缓解疼痛和最大化功能。The Chain(自行车对抗臀部疼痛)干预是一种团体自行车和教育干预，旨在实施NICE指导。自行车和教育(CLEAT)是一项务实的、两个平行手臂的随机对照试验，比较链条和标准理疗护理治疗轻至中度髋关节骨性关节炎的疗效。我们将在24个月的招聘期内招募256名转介给当地NHS理疗部的参与者。根据NICE指南诊断为髋关节骨性关节炎并符合全科医生运动推荐标准的参与者将有资格参加。主要结果是接受链式和标准理疗护理的患者在髋关节残疾和骨关节炎结果评分(HOOS)功能、日常生活能力方面的差异。次要结果包括基于绩效的功能测量(40米步行、30秒椅子站立和爬楼梯测试)、患者自我护理能力(患者激活测量)以及自我报告的健康相关资源使用情况，包括一级和二级护理接触者。主要经济终点是24周随访时的质量调整寿命年(QALY)数。这项研究由国家卫生研究所资助，患者福利研究PB-PG-0816-20033。文献指出，缺乏高质量的试验来了解髋关节骨性关节炎患者治疗中的教育和锻炼的内容和设计，并探索成本效益。CLEAT是一项务实的试验，旨在建立进一步的证据，证明在随机、对照试验环境下，与标准物理治疗相比，连锁干预的临床好处，并检查其成本效益。ISRCTN19778222。议定书4.1版，2022年10月24日。网上版载有补充材料，可在10.1186/s12891-023-06456-0查阅。
Osteoarthritis (OA) is a chronic degenerative joint disorder for which there is no known cure. Non-surgical management for people with mild-to-moderate hip OA focuses mainly on alleviating pain and maximising function via the National Institute for Health and Care Excellence (NICE) recommended combination of education and advice, exercise, and, where appropriate, weight loss. The CHAIN (Cycling against Hip pAIN) intervention is a group cycling and education intervention conceived as a way of implementing the NICE guidance. CycLing and EducATion (CLEAT) is a pragmatic, two parallel arm, randomised controlled trial comparing CHAIN with standard physiotherapy care for the treatment of mild-to-moderate hip OA. We will recruit 256 participants referred to the local NHS physiotherapy department over a 24-month recruitment period. Participants diagnosed with hip OA according to NICE guidance and meeting the criteria for GP exercise referral will be eligible to participate. Primary outcome is the difference in Hip Disability and Osteoarthritis Outcome Score (HOOS) function, daily living subscale between those receiving CHAIN and standard physiotherapy care. Secondary outcomes include performance-based functional measures (40 m walking, 30s chair stand and stair climb tests), ability for patient to self-care (patient activation measure) and self-reported health-related resource use including primary and secondary care contacts. The primary economic endpoint is the number of quality adjusted life years (QALYs) at 24 weeks follow-up. The study is funded by the National Institute for Health Research, Research for Patient Benefit PB-PG-0816-20033. The literature identifies a lack of high-quality trials which inform on the content and design of education and exercise in the treatment of patients with hip OA and explore cost-effectiveness. CLEAT is a pragmatic trial which seeks to build further evidence of the clinical benefits of the CHAIN intervention compared to standard physiotherapy care within a randomised, controlled trial setting, and examine its cost-effectiveness. ISRCTN19778222. Protocol v4.1, 24th October 2022. The online version contains supplementary material available at 10.1186/s12891-023-06456-0.
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影响因子：
3.5
作者：
Herdman, M.;Gudex, C.;Lloyd, A.;Janssen, M. F.;Kind, P.;Parkin, D.;Bonsel, G.;Badia, X.
通讯作者：
Badia, X.
影响因子：
2.1
作者：
Klässbo, M;Larsson, E;Mannevik, E
通讯作者：
Mannevik, E
影响因子：
7
作者：
Abbott, J. H.;Wilson, R.;Braund, Rhiannon
通讯作者：
Braund, Rhiannon
DOI：
10.1136/bmj.e7586
发表时间：
2013-01-08
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Chan AW;Tetzlaff JM;Gøtzsche PC;Altman DG;Mann H;Berlin JA;Dickersin K;Hróbjartsson A;Schulz KF;Parulekar WR;Krleza-Jeric K;Laupacis A;Moher D
通讯作者：
Moher D
影响因子：
4.4
作者：
Faria, Rita;Gomes, Manuel;Epstein, David;White, Ian R.
通讯作者：
White, Ian R.