Childhood is a critical period in the development and consolidation of healthy habits, such as the practice of physical activity (PA). It is essential to have valid instruments to measure PA from an early age. The aim of this study was to design and evaluate the content validity of the Physical Activity Questionnaire-Young Children (PAQ-YC) to measure the PA level in children aged 5–7 years. The first version of the questionnaire was tested by a 2-round Delphi study. It was established as a consensus criterion that the relative interquartile range (RIR) and/or the coefficient of variation (CV) were ≤20%. The most significant discrepancies in the Delphi survey (n = 11–13) were observed for items about hours of Physical Education or similar activities at school (item 7: RIR = 20, CV = 38.73) and for items about participation in Physical Education (item 8: RIR = 25, CV = 15.45). The cognitive interviews (n = 5) confirmed the version agreed by the experts. The results show that the PAQ-YC presents adequate content validity in terms of relevance, comprehensiveness and comprehensibility.
Background
Falls represent important drivers of intrinsic capacity losses, functional limitations and reduced quality of life in the growing older adult’s population, especially among those presenting with frailty. Despite exercise- and cognitive training-based interventions have shown effectiveness for reducing fall rates, evidence around their putative cumulative effects on falls and fall-related complications (such as fractures, reduced quality of life and functional limitations) in frail individuals remains scarce. The main aim of this study is to explore the effectiveness program combining an individualized exercise program and an executive function-based cognitive training (VIVIFRAIL-COGN) compared to usual care in the prevention of falls and fall-related outcomes over a 1-year follow-up.
Methods
This study is designed as a four-center randomized clinical trial with a 12-week intervention period and an additional 1-year follow-up. Three hundred twenty frail or pre-frail (≥ 1 criteria of the Frailty Phenotype) older adults (≥ 75 years) with high risk of falling (defined by fall history and gait performance) will be recruited in the Falls Units of the participating centers. They will be randomized in a 1:1 ratio to the intervention group (IG) or the control group (CG). The IG will participate in a home-based intervention combining the individualized Vivifrail multicomponent (aerobic, resistance, gait and balance and flexibility) exercise program and a personalized executive function-based cognitive training (VIVIFRAIL-COGN). The CG group will receive usual care delivered in the Falls Units, including the Otago Exercise Program. Primary outcome will be the incidence of falls (event rate/year) and will be ascertained by self-report during three visits (at baseline, and 6 and 12 weeks) and telephone-based contacts at 6, 9 and 12 months after randomization. Secondarily, effects on measures of physical and cognitive function, quality of life, nutritional, muscle quality and psychological status will be evaluated.
Discussion
This trial will provide new evidence about the effectiveness of an individualized multidomain intervention by studying the effect of additive effects of cognitive training and physical exercise to prevent falls in older frail persons with high risk of falling. Compared to usual care, the combined intervention is expected to show additive effects in the reduction of the incidence of falls and associated adverse outcomes.
Trial registration
NCT04911179 02/06/2021.
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