Effectiveness of physical exercise for people with chronic diseases: the EFIKRONIK study protocol for a hybrid, clinical
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(2020) 21:227
STUDY PROTOCOL
Open Access
Effectiveness of physical exercise for people with chronic diseases: the EFIKRONIK study protocol for a hybrid, clinical and implementation randomized trial María Soledad Arietaleanizbeaskoa1* , Aintzane Sancho2, Iñigo Olazabal3, Concepcion Moreno4, Erreka Gil1, Arturo Garcia-Alvarez1, Nere Mendizabal1, Ibon de la Fuente1, Silvia Dominguez1, Susana Pablo1, Gonzalo Grandes1 and on behalf of the EfiKroniK group
Abstract Background: 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 doseresponse 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. (Continued on next page)
* Correspondence: [email protected] 1 Primary Care Group on Health, Prevention and Chronic Diseases, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903 Barakaldo, Bizkaia, Spain Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing,
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