Effects of a 12-week multicomponent exercise programme on physical function in older adults with cancer: Study protocol for the ONKO-FRAIL randomised controlled trial

García-García, Julia and Rodriguez-Larrad, Ana and de Rituerto Zeberio, Maren Martinez and Mediavilla, Jenifer Gómez and Vicente, Borja López-San and Artola, Nuria Torrego and Etxetxipia, Izaskun Zeberio and Garmendia, Irati and Alberro, Ainhoa and Otaegui, David and Rabasco, Francisco Borrego and Caffarel, María M. and Vrotsou, Kalliopi and Irazusta, Jon and Arrieta, Haritz and Peláez, Mireia and Belloso, Jon and Basterretxea, Laura UNSPECIFIED, UNSPECIFIED, UNSPECIFIED, UNSPECIFIED, UNSPECIFIED, UNSPECIFIED, UNSPECIFIED, UNSPECIFIED, UNSPECIFIED, UNSPECIFIED, UNSPECIFIED, UNSPECIFIED, UNSPECIFIED, UNSPECIFIED, UNSPECIFIED, mireia.pelaez@uneatlantico.es, UNSPECIFIED, UNSPECIFIED (2026) Effects of a 12-week multicomponent exercise programme on physical function in older adults with cancer: Study protocol for the ONKO-FRAIL randomised controlled trial. Journal of Geriatric Oncology, 17 (2). p. 102818. ISSN 18794068

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Abstract

Introduction Cancer in older adults is often associated with functional limitations, geriatric syndromes, poor self-rated health, vulnerability, and frailty, and these conditions might worsen treatment-related side effects. Recent guidelines for patients with cancer during and after treatment have documented the beneficial effects of exercise to counteract certain side effects; however, little is known about the role of exercise during cancer treatment in older adults. Materials and Methods This is a multicentre randomised controlled trial in which 200 participants will be allocated to a control group or an intervention group (the sample size has been calculated to detect a clinical difference of 1 point in Short Physical Performance Battery (SPPB) score, assuming an α error of 0.05, a β error of 0.20, and a 10 % loss rate). Patients aged ≥70 years, diagnosed with any type of solid cancer and candidates for systemic treatment are eligible. Subjects in the intervention group are invited to participate in a 12-week supervised multicomponent exercise programme in addition to receiving usual care. Study assessments are conducted at baseline and three months. The primary outcome measure is physical function as assessed by the SPPB. Secondary outcome measures include comprehensive geriatric assessment scores (including social situation, basic and instrumental activities of daily living, cognitive function, depression, nutritional status, polypharmacy, geriatric syndromes, pain, and emotional distress), anthropometric characteristics, frailty status, physical fitness, physical activity, cognitive function, quality of life, fatigue, and nutritional status. Study assessments also include analysis of inflammatory, endocrine, and nutritional mediators in serum and plasma as potential frailty biomarkers at mRNA and protein levels and multiparametric flow cytometric analysis to measure immunosenescence markers on T and NK cells. Discussion This study seeks to extend our knowledge on exercise interventions during systemic anticancer treatment in patients over 70 years of age. Results from this research will guide the management of older adults during systemic treatment in hospitals seeking to enhance the standard of care.

Item Type:	Article
Uncontrolled Keywords:	Older adults Cancer Oncogeriatrics Exercise Physical function Frailty Biomarkers Randomised controlled trial
Subjects:	Subjects > Physical Education and Sport
Divisions:	Europe University of Atlantic > Research > Scientific Production
Depositing User:	Sr Bibliotecario
Date Deposited:	12 Dec 2025 09:19
Last Modified:	12 Dec 2025 09:19
URI:	http://repositorio.funiber.org/id/eprint/17889

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