Implementing exercise in standard cancer care (bizi orain hybrid exercise program): protocol for a randomized controlled trial

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dc.contributor.authorArietaleanizbeaskoa, María Soledad
dc.contributor.authorGil Rey, Erreka
dc.contributor.authorMendizabal Gallastegui, Nere
dc.contributor.authorGarcía Álvarez, Arturo
dc.contributor.authorde la Fuente, Ibon
dc.contributor.authorDomínguez Martínez, Silvia
dc.contributor.authorPablo, Susana
dc.contributor.authorCoca Núñez, Aitor
dc.contributor.authorGutiérrez Santamaría, Borja
dc.contributor.authorGrandes Odriozola, Gonzalo
dc.date.accessioned2025-06-14T10:35:19Z
dc.date.available2025-06-14T10:35:19Z
dc.date.issued2021-08-01
dc.date.updated2025-06-14T10:35:19Z
dc.description.abstractBackground: Despite the established benefits of regular exercise for patients with cancer to counteract the deleterious effects of the disease itself and treatment-related adverse effects, most of them do not engage in sufficient levels of physical activity and there is a paucity of data on the integration of efficacious exercise programs that are accessible and generalizable to a large proportion of patients with cancer into routine cancer care. Objective: We intend to examine the effects attributable to the implementation of a community-based exercise program on cardiorespiratory functional capacity and quality of life for patients with cancer. Methods: This will be a hybrid study. In the first experimental phase, patients diagnosed with any type of cancer will be randomized into two parallel groups. One group immediately performs Bizi Orain, a 3-month supervised exercise program (3 times a week), in addition to behavioral counseling in a primary health care setting; the other is a reference group that starts the exercise program 3 months later (delayed treatment). In the second observational phase, the entire cohort of participants will be followed-up for 5 years. Any person diagnosed with cancer in the previous 2 years is eligible for the program. The program evaluation involves the uptake, safety, adherence, and effectiveness assessed after completion of the program and with follow-ups at 3, 6, 12, 24, 36, 48, and 60 months. The primary outcomes of the experimental study, to be compared between groups, are improved physical function and quality of life, whereas overall survival is the main objective of the prospective study. To analyze the association between changes in physical activity levels and overall survival, longitudinal mixed-effects models will be used for repeated follow-up measures. Results: A total of 265 patients have been enrolled into the study since January 2019, with 42 patients from the hematology service and 223 from the oncology service. Conclusions: Bizi Orain is the first population-based exercise program in Spain that will offer more insight into the implementation of feasible, generalizable, and sustainable supportive care services involving structured exercise to extend survival of patients with cancer, improve their physical function and quality of life, and reverse the adverse effects of their disease and related treatments, thereby reducing the clinical burden. Trial Registration: ClinicalTrials.gov NCT03819595; http://clinicaltrials.gov/ct2/show/NCT03819595 International Registered Report Identifier (IRRID): DERR1-10.2196/24835.en
dc.description.sponsorshipThis study has been funded by Instituto de Salud Carlos III through the project “PI18-00929” (Cofunded by European Regional Development Fund/European Social Fund “A way to make Europe”/“Investing in your future”)en
dc.identifier.citationArietaleanizbeaskoa, M. S., Rey, E. G., Gallastegui, N. M., García-Álvarez, A., de la Fuente, I., Domínguez-Martinez, S., Pablo, S., Coca, A., Santamaría, B. G., & Grandes, G. (2021). Implementing exercise in standard cancer care (bizi orain hybrid exercise program): protocol for a randomized controlled trial [Review of Implementing exercise in standard cancer care (bizi orain hybrid exercise program): protocol for a randomized controlled trial]. JMIR Research Protocols, 10(8). JMIR Publications Inc. https://doi.org/10.2196/24835
dc.identifier.doi10.2196/24835
dc.identifier.eissn1929-0748
dc.identifier.urihttp://hdl.handle.net/20.500.14454/3058
dc.language.isoeng
dc.publisherJMIR Publications Inc.
dc.rights©Maria Soledad Arietaleanizbeaskoa, Erreka Gil Rey, Nere Mendizabal Gallastegui, Arturo García-Álvarez, Ibon De La Fuente, Silvia Domínguez-Martinez, Susana Pablo, Aitor Coca, Borja Gutiérrez Santamaría, Gonzalo Grandes
dc.subject.otherBehavioral change
dc.subject.otherOverall survival
dc.subject.otherPatients with cancer
dc.subject.otherPhysical activity
dc.subject.otherPrimary care
dc.subject.otherRandomized controlled trial
dc.titleImplementing exercise in standard cancer care (bizi orain hybrid exercise program): protocol for a randomized controlled trialen
dc.typereview article
dcterms.accessRightsopen access
oaire.citation.issue8
oaire.citation.titleJMIR Research Protocols
oaire.citation.volume10
oaire.licenseConditionhttps://creativecommons.org/licenses/by/4.0/
oaire.versionVoR
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