Reducing concerns about falling in older adults: evaluation of a multi-component intervention and the role of stress and inflammation markers - long-term effects of the FEARFALL randomized controlled trial.

BACKGROUND: Concerns about falling (CaF) are common in older adults and associated with reduced activity and poorer health. This study investigated, for the first time, the long-term effects of a multi-component intervention targeting CaF on psychological, functional, biophysiological, and anthropometric outcomes. METHODS: 160 community-dwelling older adults (≥ 70 years) were randomly assigned to a 4-month intervention featuring exercise and cognitive-behavioral training or to a sham control group. CaF and related psychological outcomes were assessed using validated questionnaires. Salivary cortisol and α-amylase, physical function, activity, body composition and inflammatory markers (C-reactive protein [CRP]-, interleukin-6 [IL-6], interleukin-10 [IL-10], interleukin-1β [IL-1β] and tumor necrosis factor-alpha [TNF-α]) were analyzed at baseline, post-intervention, and 8-month follow-up. RESULTS: All estimates represent T0-T2 estimated marginal mean differences. There was no intervention effect or long-term superiority between the groups. Significant time effects were observed for CaF and physiological biomarkers for stress axis activity and inflammatory markers. Functional outcomes changed only marginally. CONCLUSION: CaF improved similarly in both groups. Changes in basal stress system activity and inflammatory cytokines were highly comparable between groups. Contrary to our hypothesis, the intervention did not confer additional benefits over the sham control intervention in reducing CaF. TRIAL REGISTRATION: German Clinical Trials Register (DRKS): DRKS00029171. Registered 22 July 2022, https://drks.de/search/de/trial/DRKS00029171 .