Yonchuk John G, Mohan Divya, LeBrasseur Nathan K, George Ashley R, Singh Sally, Tal-Singer Ruth
Research and Development Technology, GlaxoSmithKline, Collegeville, Pennsylvania, United States.
Research and Development, GlaxoSmithKline, Collegeville, Pennsylvania, United States.
Chronic Obstr Pulm Dis. 2021 Apr 27;8(2):269-276. doi: 10.15326/jcopdf.2020.0194.
Pulmonary rehabilitation (PR) is an important therapy for patients with chronic obstructive pulmonary disease (COPD), yet uptake remains low. Intervention strategies which recapitulate the benefits of PR are, therefore, needed and digital, home-based therapies present opportunity in this space. Digital therapies also potentially offer an opportunity to standardize PR in clinical trials for new COPD therapies.
We aimed to create a digital application (app), Respercise, consisting of up to 4 strengthening exercises in conjunction with Therbands™ and a daily physical activity program with individualized step goals, and to test its feasibility in a clinical trial. App usability was surveyed qualitatively before development iterations and deployment in a 13-week interventional clinical trial. All participants who completed the study were invited for an exit interview and performed the 5-repetition sit-to-stand test amongst other measures.
Feedback from clinical trial participants was positive; 97% of respondents liked the app. A total of 88% of participants reported that it was easy to fit the exercises into their daily routine, and there was over 90% adherence for entering daily step counts. Notably, on day 90 both females and males using Respercise alone demonstrated a 2.22- and 2.27-seconds improvement in time for 5-repetition sit-to-stand tests respectively, above the 1.7 second threshold that is considered clinically meaningful in COPD.
Respercise can be successfully deployed in clinical trials, offering the opportunity for standardization of exercise in clinical trials and, with further development, could have wider reach as a home-based intervention for individuals with COPD.
肺康复（PR）是慢性阻塞性肺疾病（COPD）患者的重要治疗方法，但采用率仍然较低。因此，需要一些能够概括PR益处的干预策略，而数字化的家庭疗法在这方面提供了机会。数字疗法还可能为新的COPD疗法的临床试验中PR的标准化提供机会。
我们旨在创建一个数字应用程序（应用）Respercise，它包括多达4项结合Therbands™的强化运动以及一个带有个性化步数目标的日常身体活动计划，并在一项临床试验中测试其可行性。在开发迭代之前和在一项为期13周的干预性临床试验中部署之前，对应用的可用性进行了定性调查。所有完成研究的参与者都被邀请参加退出访谈，并进行了5次重复坐立试验等测量。
临床试验参与者的反馈是积极的；97%的受访者喜欢这个应用。共有88%的参与者报告说，将这些运动融入他们的日常生活很容易，并且输入每日步数的依从性超过90%。值得注意的是，在第90天，单独使用Respercise的女性和男性在5次重复坐立试验中的时间分别改善了2.22秒和2.27秒，超过了在COPD中被认为具有临床意义的1.7秒阈值。
Respercise可以成功地应用于临床试验，为临床试验中的运动标准化提供机会，并且随着进一步发展，作为一种针对COPD患者的家庭干预措施，其应用范围可能更广。
