BMJ open · 2026
Fun Exercise for Older Adults (FEXO): study protocol for a randomised controlled trial on intrinsic capacity, adherence and motivation.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод пока не подготовлен
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Azanon-Nogueira Pedro, García-Lucas Celia, Salvador-Huerta Carlos, Amer-Cuenca Juan José, Picher Martínez Miguel, García-Zamora Mar, Lisón Juan Francisco, Benavent-Caballer Vicent
Аннотация
INTRODUCTION: Ageing is associated with declines in physical and cognitive function that increase the risk of disability and dependence. Intrinsic capacity (IC), proposed by the WHO, provides a multidimensional framework to assess health in older adults. This study aims to evaluate whether a multicomponent recreational exercise programme (Fun Exercise for Older Adults (FEXO)) improves IC, motivation and adherence compared with a conventional programme (OTAGO).
METHODS AND ANALYSIS: A randomised controlled trial with two groups (2:1 ratio) will be conducted among 120 community-dwelling older adults (≥60 years). Participants will be randomly assigned to FEXO (intervention) or OTAGO (control). Both programmes will consist of 3 weekly sessions for 14 weeks.
PRIMARY OUTCOMES: IC, assessed through validated measures (Short Physical Performance Battery, Mini Nutritional Assessment, Mini-Mental State Examination, Cornell Scale for Depression in Dementia and sensory evaluation), motivation (BREQ-3) and adherence rate. Secondary outcomes include body composition, cardiovascular parameters, frailty, cognition and resilience (PRIFOR). Data will be analysed using two-way ANOVA (group×time) under an intention-to-treat approach. Effect sizes (ηp²) and 95% CIs will be reported. Additional analyses (correlation, regression, mediation and moderation) will explore associations and intervention effects.
ETHICS AND DISSEMINATION: Approved by the Ethics Committee of Universidad CEU Cardenal Herrera (Ref. CEEI23/487 and CEEI25/639). Results will be disseminated through peer-reviewed journals and scientific conferences. The findings of this study will contribute to improving evidence-based strategies for promoting healthy ageing and will support the development of more engaging and effective exercise interventions for older adults.
TRIAL REGISTRATION NUMBER: This study has been prospectively registered at ClinicalTrials.gov (identifier: NCT07133568).
METHODS AND ANALYSIS: A randomised controlled trial with two groups (2:1 ratio) will be conducted among 120 community-dwelling older adults (≥60 years). Participants will be randomly assigned to FEXO (intervention) or OTAGO (control). Both programmes will consist of 3 weekly sessions for 14 weeks.
PRIMARY OUTCOMES: IC, assessed through validated measures (Short Physical Performance Battery, Mini Nutritional Assessment, Mini-Mental State Examination, Cornell Scale for Depression in Dementia and sensory evaluation), motivation (BREQ-3) and adherence rate. Secondary outcomes include body composition, cardiovascular parameters, frailty, cognition and resilience (PRIFOR). Data will be analysed using two-way ANOVA (group×time) under an intention-to-treat approach. Effect sizes (ηp²) and 95% CIs will be reported. Additional analyses (correlation, regression, mediation and moderation) will explore associations and intervention effects.
ETHICS AND DISSEMINATION: Approved by the Ethics Committee of Universidad CEU Cardenal Herrera (Ref. CEEI23/487 and CEEI25/639). Results will be disseminated through peer-reviewed journals and scientific conferences. The findings of this study will contribute to improving evidence-based strategies for promoting healthy ageing and will support the development of more engaging and effective exercise interventions for older adults.
TRIAL REGISTRATION NUMBER: This study has been prospectively registered at ClinicalTrials.gov (identifier: NCT07133568).