Salvador-Ruiz Andres J, Moral-Munoz Jose A, Salazar Alejandro, Lucena-Anton David, De Sola Helena, Failde Inmaculada, Dueñas María
Department of Nursing and Physiotherapy, University of Cadiz, Cadiz, Spain.
Biomedical Research and Innovation Institute of Cadiz (INiBICA), Cadiz, Spain.
Digit Health. 2024 Oct 29;10:20552076241247936. doi: 10.1177/20552076241247936. eCollection 2024 Jan-Dec.
To analyse the effectiveness of a physical exercise programme guided by a mobile health technology system (COVIDReApp) for patients with post-acute COVID-19 syndrome. This syndrome is a multisystem disease that occurs in people with a history of COVID-19 between 1 and 3 months after the onset of the disease. This study will assess the impact of the intervention on fatigue, post-exertional dyspnoea, quality of life, pain severity, physical fitness, anxiety, depression and cognitive function. We also aim to analyse whether there are associations between the variables studied and the evolution of these associations during follow-up.
A single-blind randomised controlled trial.
One hundred patients diagnosed with post-acute COVID-19 will be enrolled and randomly assigned to two groups. The experimental group will perform the intervention through a physical exercise programme guided by the COVIDReApp system, whereas the control group will perform the programme in paper format. Study outcomes will be collected at baseline and at 4, 12 and 24 weeks. Student's -tests or Mann-Whitney -tests will be used to analyse differences between groups, mixed ANOVA for differences over time and longitudinal structural equations for associations between variables at follow-up.
This study is based on current evidence regarding exercise prescription recommendations for patients with post-acute COVID-19 syndrome. Our intervention is supported by a solid theoretical framework; however, challenges include tailoring the physical exercise programme to everyone's predominant symptoms and ensuring adherence to the programme.
NCT05725538.
分析由移动健康技术系统（COVIDReApp）指导的体育锻炼计划对急性 COVID-19 综合征后患者的有效性。该综合征是一种多系统疾病，发生在有 COVID-19 病史的患者中，在疾病发作后 1 至 3 个月之间。本研究将评估该干预措施对疲劳、运动后呼吸困难、生活质量、疼痛严重程度、身体素质、焦虑、抑郁和认知功能的影响。我们还旨在分析所研究变量之间是否存在关联以及在随访期间这些关联的演变情况。
单盲随机对照试验。
招募 100 名被诊断为急性 COVID-19 后综合征的患者，并随机分为两组。实验组将通过由 COVIDReApp 系统指导的体育锻炼计划进行干预，而对照组将以纸质形式进行该计划。研究结果将在基线以及第 4、12 和 24 周收集。将使用学生 t 检验或曼-惠特尼 U 检验来分析组间差异，使用混合方差分析来分析随时间的差异，并使用纵向结构方程来分析随访期间变量之间的关联。
本研究基于当前关于急性 COVID-19 综合征后患者运动处方建议的证据。我们的干预措施有坚实的理论框架支持；然而，挑战包括根据每个人的主要症状调整体育锻炼计划，并确保对该计划的依从性。
NCT05725538。
