Effectiveness of a multifactorial program versus a multicomponent program on falls prevention in older adults: randomized clinical trial protocol
e202608044
DOI:
https://doi.org/10.67113/resp.v100i1.1013Keywords:
Risk of falls, Elderly, Prevention, Clinical trialAbstract
BACKGROUND // Falls in older adults represent a major public health problem due to their high prevalence, associated morbidity and mortality, and healthcare costs. More than 400 risk factors have been identified, many of them modifiable. Previous studies show heterogeneous results regarding the effectiveness of multifactorial and multicomponent interventions, especially in community-dwelling populations. In this context, a clinical trial is proposed to assess the comparative efficacy of both approaches in preventing falls among people aged 65 years and older.
METHODS // A two‑arm randomized clinical trial will be conducted with 264 participants recruited from urban primary care centers in the Talavera de la Reina Healthcare Area. The inclusion criteria consider functional independence, the ability to ambulate, and a high risk of falling. After baseline assessment, participants will be assigned either to a multifactorial intervention including supervised Vivifrail© exercise, home assessment, medication review, and multidisciplinary educational session or to a multicomponent intervention consisting of unsupervised exercise and a single educational session. Follow-up will last twenty-four months. The primary outcome will be the number of recorded falls. Negative binomial and logistic regression models will be used for the analysis.
ETHICAL CONSIDERATIONS // Protocol Version 1 was approved by the Research Ethics Committee of Talavera de la Reina Healthcare Area (Ref. 57/2020).
DISCUSSION // The multifactorial intervention is expected to reduce falls by 15% and improve functional capacity and quality of life. The findings may support the development of a standardized fall-prevention protocol applicable in primary care.
REGISTER // ClinicalTrials.gov Identifier: NCT05682872.
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