Pneumologie, Zürcher RehaZentren Klinik Wald, Faltigbergstrasse 7, 8636, Wald, Switzerland.
Faculty of Health, Department of Pulmonary Medicine, University of Witten/Herdecke, 58448, Witten, Germany.
Trials. 2020 Jul 11;21(1):636. doi: 10.1186/s13063-020-04538-1.
BACKGROUND: Increasing physical activity (PA) is considered to be an important factor for the efficient management of chronic obstructive pulmonary disease (COPD). Successful methods required to achieve improvements in PA following pulmonary rehabilitation (PR), however, are rarely reported. Therefore, we will conduct this trial to evaluate the effectiveness of using a COPD management program delivered to the patient via the KAIA COPD app, a mobile medical application, after the completion of PR. METHODS: This is the protocol for a randomized, controlled, open-label, multicentered trial that will be carried out at inpatient PR hospital centers in Germany and Switzerland. The interventions will involve the use of the KAIA COPD app program (Arm 1) or an active comparator, i.e., usual care (Arm 2). Patients completing an in-hospital PR program and consenting to participate in the study will be screened with the inclusion and exclusion criteria and enrolled in the study. After fulfilling the screening requirements, the patients will be randomized into one of the two arms with parallel group assignment in a 1:1 ratio. The training program will be delivered to the participants grouped in Arm 1 via the KAIA COPD app and to participants grouped in Arm 2 via the regular recommendations or standard of care by the PI. In total, 104 participants will be included in the trial. The treatment period will last for 24 weeks. Electronic versions of questionnaires will be used to collect patient-reported assessments remotely. The primary outcome measure is the change in physical activity of the intervention group in comparison to the control group, measured over 1 week as the mean steps per day with a Polar A 370 activity tracker, from baseline (end of PR) to the 6-month follow-up. The secondary outcome measures are functional exercise capacity, health status, sleep quality, exacerbation rate, and depression and anxiety symptoms assessed at several intervals. DISCUSSION: This study seeks to prove the effects of the KAIA COPD mobile application in COPD patients after PR. The app offers educational, exercise training plus activity monitoring and motivational programs that can be easily implemented in the patient's home setting, enabling patients to maintain the effects that are typically elicited in the short term after pulmonary rehabilitation for the long term. TRIAL REGISTRATION: German Clinical Trials Register ( DRKS00017275 ). Protocol version 2.0 dated 3 June 2019.
背景:增加身体活动(PA)被认为是有效管理慢性阻塞性肺疾病(COPD)的重要因素。然而,在肺康复(PR)后实现 PA 改善所需的成功方法却很少有报道。因此,我们将开展这项试验,以评估在 PR 完成后通过 KAIA COPD 应用程序(一种移动医疗应用程序)向患者提供 COPD 管理方案的有效性。
方法:这是一项在德国和瑞士住院 PR 医院中心进行的随机、对照、开放标签、多中心试验的方案。干预措施将包括使用 KAIA COPD 应用程序程序(第 1 组)或积极对照,即常规护理(第 2 组)。完成住院 PR 计划并同意参加研究的患者将根据纳入和排除标准进行筛选,并纳入研究。在满足筛选要求后,患者将以 1:1 的比例随机分为两组中的一组。将通过 KAIA COPD 应用程序向第 1 组的参与者提供培训计划,向第 2 组的参与者提供 PI 的常规建议或标准护理。总共将纳入 104 名参与者。治疗期将持续 24 周。将使用电子问卷远程收集患者报告的评估结果。主要结局指标是干预组与对照组相比,在 1 周内通过 Polar A 370 活动追踪器测量的平均每日步数的变化,从基线(PR 结束)到 6 个月随访。次要结局指标是功能运动能力、健康状况、睡眠质量、恶化率以及抑郁和焦虑症状,这些指标在多个时间点进行评估。
讨论:这项研究旨在证明 KAIA COPD 移动应用程序在 PR 后对 COPD 患者的影响。该应用程序提供教育、运动训练加活动监测和激励计划,可轻松在患者家中实施,使患者能够将 PR 后短期内通常产生的效果长期维持下去。
试验注册:德国临床试验注册(DRKS00017275)。2019 年 6 月 3 日的协议版本 2.0。
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