背景:广泛建议肺康复以改善功能状态,并作为慢性肺部疾病患者的二级和三级预防。不幸的是,获得及时和适当康复的机会仍然有限。为了帮助缩小这个难以接近的差距,已经提出了远程康复。然而,运动测试对于有效和安全的运动处方是必要的。当前的黄金标准测试,如最大心肺运动测试(CPET)和6分钟步行测试(6MWT),不太适应家庭或远程康复设置。这是COVID-19大流行期间服务连续性的障碍。验证适应这些新现实的测试至关重要,如6分钟步进测试(6MST)。这个测试,受到6MWT的强烈启发,包括在“步进机”上尽可能多的步骤,持续6分钟。
目的:本研究旨在通过(1)在6MST和CPET之间建立并发有效性和一致性来评估6MST的计量质量,以及6MWT;(2)在具有直接和远程(视频会议)监控的基于家庭的环境中确定重测可靠性;(3)在基于家庭的环境中执行6MST时记录不良事件和参与者观点。
方法:三个中心(魁北克心脏病学和肺气学研究所中心,法国里尔天主教研究所集团,和法国的FormActionSanté)将参与这个跨国项目,分为2项研究。对于研究1(目标1),30名参与者(魁北克,n=15;法国,n=15)将被招募。将进行两次实验室访问以评估人体测量数据,肺功能,和3项运动耐量测试(CPET,6MWT,和6MST)。将评估并发有效性(配对样本t检验和Pearson相关性)和一致性(具有95%一致性限制的Bland-Altman地块)。对于研究2(目标2和3),52名参与者(魁北克,n=26;法国,n=26)将被招募。在熟悉试验(试验1)之后,6MST将在2个不同的场合进行(试验2和3),一次在直接监督下,一次在远程监督下,以随机顺序。配对样本t检验,Bland-Altman阴谋,和组内相关性将用于比较试验2和3。第三次试验后将进行半结构化访谈,以收集参与者的观点。
结果:该项目获得了道德批准(2023年10月12日在魁北克,2023年9月25日在法国),并且在2024年2月招募了第一名参与者。
结论:这项研究通过验证一种新的临床测试来创新,该测试是开发和实施适应家庭和远程康复环境的新康复模式所必需的。这项研究还与联合国可持续发展目标保持一致,有助于增加医疗保健服务的提供(目标3)和减少医疗保健机会不平等(目标11)。
背景:ClinicalTrials.govNCT06447831;https://clinicaltrials.gov/study/NCT06447831。
■DERR1-10.2196/57404。
BACKGROUND: Pulmonary rehabilitation is widely recommended to improve functional status and as secondary and tertiary prevention in individuals with chronic pulmonary diseases. Unfortunately, access to timely and appropriate rehabilitation remains limited. To help close this inaccessibility gap, telerehabilitation has been proposed. However, exercise testing is necessary for effective and safe exercise prescription. Current gold-standard tests, such as maximal cardiopulmonary exercise testing (CPET) and the 6-minute walk test (6MWT), are poorly adapted to home-based or telerehabilitation settings. This was an obstacle to the continuity of services during the COVID-19 pandemic. It is essential to validate tests adapted to these new realities, such as the 6-minute stepper test (6MST). This test, strongly inspired by 6MWT, consists of taking as many steps as possible on a \"stepper\" for 6 minutes.
OBJECTIVE: This study aims to evaluate the metrological qualities of 6MST by (1) establishing concurrent validity and agreement between the 6MST and CPET, as well as with the 6MWT; (2) determining test-retest reliability in a home-based setting with direct and remote (videoconferencing) monitoring; and (3) documenting adverse events and participant perspectives when performing the 6MST in home-based settings.
METHODS: Three centers (Centre de recherche de l\'Institut universitaire de cardiologie et de pneumologie de Québec in Québec, Groupement des Hôpitaux de l\'Institut Catholique de Lille in France, and FormAction Santé in France) will be involved in this multinational project, which is divided into 2 studies. For study 1 (objective 1), 30 participants (Québec, n=15; France, n=15) will be recruited. Two laboratory visits will be performed to assess anthropometric data, pulmonary function, and the 3 exercise tolerance tests (CPET, 6MWT, and 6MST). Concurrent validity (paired sample t tests and Pearson correlations) and agreement (Bland-Altman plots with 95% agreement limits) will be evaluated. For study 2 (objectives 2 and 3), 52 participants (Québec, n=26; France, n=26) will be recruited. Following a familiarization trial (trial 1), the 6MST will be conducted on 2 separate occasions (trials 2 and 3), once under direct supervision and once under remote supervision, in a randomized order. Paired sample t test, Bland-Altman plots, and intraclass correlations will be used to compare trials 2 and 3. A semistructured interview will be conducted after the third trial to collect participants\' perspectives.
RESULTS: Ethical approval was received for this project (October 12, 2023, in Québec and September 25, 2023, in France) and the first participant was recruited in February 2024.
CONCLUSIONS: This study innovates by validating a new clinical test necessary for the development and implementation of new models of rehabilitation adapted to home and telerehabilitation contexts. This study also aligns with the United Nations Sustainable Development Goals by contributing to augmenting health care service delivery (goal 3) and reducing health care access inequalities (goal 11).
BACKGROUND: ClinicalTrials.gov NCT06447831; https://clinicaltrials.gov/study/NCT06447831.
UNASSIGNED: DERR1-10.2196/57404.