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基于社区的干预措施促进类风湿关节炎患者的身体活动(CIPPA-RA):一项试点随机对照试验的研究方案。

Community-based intervention to promote physical activity in rheumatoid arthritis (CIPPA-RA): a study protocol for a pilot randomised control trial.

机构信息

Department of Clinical Therapies, Faculty of Education and Health Sciences, University of Limerick, Limerick, Ireland.

Department of Psychology, Faculty of Education and Health Sciences, University of Limerick, Limerick, Ireland.

出版信息

Rheumatol Int. 2017 Dec;37(12):2095-2103. doi: 10.1007/s00296-017-3850-y. Epub 2017 Oct 17.

Abstract

Rheumatoid arthritis (RA) is a chronic, inflammatory condition which may cause pain, stiffness and fatigue. People who have RA have reduced levels of physical activity due to these symptoms. Interventions targeting physical activity behaviour in this population have had limited efficacy. This paper describes a protocol for a pilot randomised controlled trial (RCT) of a theory-based intervention delivered in a community setting designed to promote physical activity in people who have RA. The aim of the pilot study is to assess the impact of the intervention on moderate-intensity physical activity in people with RA. The objectives are to obtain reliable estimates regarding recruitment rates; participant retention, protocol adherence and generate potential effect size estimates to inform sample size calculations for a main trial on physical activity participation. Semi-structured interviews will be conducted with a selected sample of participants to explore their experiences. Participants will be recruited from direct referrals from the rheumatology clinics in a public hospital. Participants meeting inclusion criteria will be randomised into a 6 week physical activity intervention (four sessions delivered over a 6-week period by a trained physiotherapist) or a control group (physical activity information leaflet). Results of the pilot study will provide data to determine if a larger RCT is feasible. Qualitative data will inform intervention design and delivery. The findings will be disseminated to health professionals, in peer-reviewed journals and conference presentations.

摘要

类风湿性关节炎(RA)是一种慢性炎症性疾病,可能导致疼痛、僵硬和疲劳。由于这些症状,患有 RA 的人身体活动水平降低。针对该人群身体活动行为的干预措施效果有限。本文介绍了一项在社区环境中进行的基于理论的干预措施的试点随机对照试验(RCT)的方案,旨在促进患有 RA 的人的身体活动。该试点研究的目的是评估干预措施对 RA 患者中中等强度身体活动的影响。目的是获得有关招募率的可靠估计;参与者保留率、方案依从性,并生成潜在的效应大小估计值,为主要的身体活动参与试验提供样本量计算依据。将对选定的参与者样本进行半结构化访谈,以探讨他们的经验。参与者将从公立医院的风湿病诊所直接转介中招募。符合纳入标准的参与者将随机分为 6 周的身体活动干预组(由经过培训的物理治疗师在 6 周内提供 4 次治疗)或对照组(身体活动信息传单)。试点研究的结果将提供数据,以确定是否可行更大规模的 RCT。定性数据将为干预措施的设计和实施提供信息。研究结果将在专业会议上发表,并在同行评议期刊和会议报告中进行传播。

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