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基于网络的干预措施促进青少年和年轻成人囊性纤维化患者的体力活动:一项随机对照试验的方案。

A web-based intervention to promote physical activity in adolescents and young adults with cystic fibrosis: protocol for a randomized controlled trial.

机构信息

Monash University, La Trobe University and Institute for Breathing and Sleep, Level 6, The Alfred Centre, 99 Commercial Road, Melbourne, Vic, 3004, Australia.

La Trobe University, Level 4, The Alfred Centre, 99 Commercial Road, Melbourne, Vic, 3004, Australia.

出版信息

BMC Pulm Med. 2019 Dec 19;19(1):253. doi: 10.1186/s12890-019-0942-3.

Abstract

BACKGROUND

Regular participation in physical activity by people with cystic fibrosis (CF) promotes positive clinical and health outcomes including reduced rate of decline in lung function, fewer hospitalizations and greater wellbeing. However adherence to exercise and activity programs is low, in part due to the substantial daily therapy burden for young people with CF. Strict infection control requirements limit the role of group exercise programs that are commonly used in other clinical groups. Investigation of methods to promote physical activity in this group has been limited. The Active Online Physical Activity in Cystic fibrosis Trial (ActionPACT) is an assessor-blinded, multi-centre, randomized controlled trial designed to compare the efficacy of a novel web-based program (ActivOnline) compared to usual care in promoting physical activity participation in adolescents and young adults with CF.

METHODS

Adolescents and young adults with CF will be recruited on discharge from hospital for a respiratory exacerbation. Participants randomized to the intervention group will have access to a web-based physical activity platform for the 12-week intervention period. ActivOnline allows users to track their physical activity, set goals, and self-monitor progress. All participants in both groups will be provided with standardised information regarding general physical activity recommendations for adolescents and young adults. Outcomes will be assessed by a blinded assessor at baseline, after completion of the intervention, and at 3-months followup. Healthcare utilization will be assessed at 12 months from intervention completion. The primary outcome is change in moderate-to-vigorous physical activity participation measured objectively by accelerometry. Secondary outcomes include aerobic fitness, health-related quality of life, anxiety and depression and sleep quality.

DISCUSSION

This trial will establish whether a web-based application can improve physical activity participation more effectively than usual care in the period following hospitalization for a respiratory exacerbation. The web-based application under investigation can be made readily and widely available to all individuals with CF, to support physical activity and exercise participation at a time and location of the user's choosing, regardless of microbiological status.

TRIAL REGISTRATION

Clinical trial registered on July 13, 2017 with the Australian and New Zealand Clinical Trials Register at (ACTRN12617001009303).

摘要

背景

规律的身体活动可促进囊性纤维化(CF)患者的临床和健康获益,包括减缓肺功能下降速度、减少住院次数和改善健康状况。然而,由于 CF 患者的日常治疗负担较重,他们对运动和活动方案的依从性较低。严格的感染控制要求限制了常用于其他临床人群的团体运动项目的应用。因此,针对该人群促进身体活动的方法研究较为有限。“囊性纤维化患者在线积极身体活动试验(ActionPACT)”是一项评估者设盲、多中心、随机对照试验,旨在比较新型基于网络的方案(ActivOnline)与常规护理在促进 CF 青少年和年轻成人参与身体活动方面的效果。

方法

将在因呼吸恶化而出院时招募 CF 青少年和年轻成人。随机分至干预组的参与者将在 12 周的干预期间访问基于网络的身体活动平台。ActivOnline 允许用户跟踪他们的身体活动、设定目标和自我监测进展。两组的所有参与者都将获得针对青少年和年轻成人一般身体活动建议的标准化信息。通过评估者在基线、干预结束后和 3 个月随访时进行评估。从干预结束 12 个月时评估医疗保健利用情况。主要结局是通过加速度计客观测量的中度至剧烈身体活动参与度的变化。次要结局包括有氧健身、健康相关生活质量、焦虑和抑郁以及睡眠质量。

讨论

该试验将确定基于网络的应用程序是否能比常规护理更有效地增加呼吸恶化住院治疗后患者的身体活动参与度。所研究的基于网络的应用程序可以方便、广泛地提供给所有 CF 患者,以在用户选择的时间和地点支持身体活动和运动参与,而不受微生物学状态的影响。

试验注册

该临床试验于 2017 年 7 月 13 日在澳大利亚和新西兰临床试验注册中心注册(ACTRN12617001009303)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab0e/6921562/642e6ca5d616/12890_2019_942_Fig1_HTML.jpg

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