Primary Care Group on Health, Prevention and Chronic Diseases, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.
Medical Oncology Group, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.
BMC Fam Pract. 2020 Nov 6;21(1):227. doi: 10.1186/s12875-020-01298-4.
Chronic illnesses are the leading cause of morbidity and mortality and threaten the sustainability of healthcare systems worldwide. There is limited evidence in terms of the best modality and intensity of physical activity for improving cardiorespiratory capacity and quality of life in patients with chronic conditions. The objective of the EfiKroniK study is to estimate the common effect of innovative, individualized and supervised physical exercise, on cardiorespiratory functional capacity and quality of life across people with different chronic conditions.
METHODS/DESIGN: This is a multicentre clinical trial with a type I hybrid effectiveness-implementation design, including 370 patients each with one of four different chronic illnesses: solid cancer, blood cancer, chronic obstructive pulmonary disease or schizophrenia. Patients will be randomly divided into two parallel groups, stratified by illness type. Patients in both groups will receive a standard healthy life prescription (PVS, from the Spanish "Prescribe Vida Saludable") and additionally, the EfiKroniK group will be prescribed a physical exercise programme tailored to each patient in terms of intensity in each session. The primary outcome variables will be cardiorespiratory functional capacity and quality of life. The secondary outcome variables will be signs and symptoms, psychological and social factors and specific laboratory parameters. We will also analyse the dose-response effect of the physical exercise programme. Qualitative variables will describe patients' perception of the utility and suitability of the EfiKroniK programme, as well as their expectations and satisfaction, identifying barriers to and facilitators of the EfiKroniK implementation process through discussion groups. The study will be carried out on an intention-to-treat basis, comparing changes throughout the 1-year follow-up between groups, adjusting for baseline, by performing mixed-effect analysis of covariance. We will estimate the effect of time on repeated measures in each subject and changes in the EfiKroniK and PVS groups over time.
The study will provide the data necessary to allow us to prescribe physical exercise in a similar way to a drug and as a key part of the treatment of chronic illnesses within our healthcare system.
NCT03810755 . Date and version identifier: October 9, 2020. Version2.0.
慢性病是发病率和死亡率的主要原因，威胁着全球医疗保健系统的可持续性。关于改善慢性病患者心肺功能能力和生活质量的最佳运动方式和强度，证据有限。EfiKroniK 研究的目的是估计创新的、个体化和监督的体育锻炼对不同慢性病患者心肺功能能力和生活质量的共同影响。
方法/设计：这是一项多中心临床试验，采用 I 型混合有效性-实施设计，包括 370 名患者，每位患者患有四种不同的慢性病之一：实体癌、血癌、慢性阻塞性肺疾病或精神分裂症。患者将按疾病类型分层随机分为两组。两组患者都将接受标准的健康生活处方（PVS，来自西班牙语“Prescribe Vida Saludable”），此外，EfiKroniK 组将根据每次治疗的强度为每位患者量身定制体育锻炼方案。主要结局变量将是心肺功能能力和生活质量。次要结局变量将是症状和体征、心理和社会因素以及特定的实验室参数。我们还将分析体育锻炼方案的剂量反应效应。定性变量将描述患者对 EfiKroniK 方案的实用性和适用性的看法，以及他们对该方案的期望和满意度，通过讨论小组确定 EfiKroniK 实施过程中的障碍和促进因素。该研究将基于意向治疗进行，通过混合效应协方差分析，比较两组在 1 年随访期间的变化，根据基线进行调整。我们将估计每个个体重复测量的时间效应以及 EfiKroniK 和 PVS 组随时间的变化。
该研究将提供必要的数据，使我们能够像开药物一样开具运动处方，并将其作为我们医疗保健系统中治疗慢性病的关键部分。
NCT03810755。日期和版本标识符：2020 年 10 月 9 日。版本 2.0。
