Abstract
OBJECTIVE: We tested the effect of the hearing intervention vs. health education control (1:1 randomization) on 3-year physical function decline, a secondary analysis of the ACHIEVE randomized trial (ClinicalTrials.gov Identifier: NCT03243422). METHODS: Pre-specified outcomes included the Short Physical Performance Battery (SPPB) [total score and components] and grip strength. Intervention effects were modeled using linear mixed models following a pre-specified statistical analysis plan. RESULTS: In 956 participants (mean 76.3 years, 53% female, 12% Black race), hearing intervention did not impact change in SPPB (difference comparing intervention to control = 0.00 standard deviation [SD] units, 95% confidence interval [CI]:-0.14, 0.14) or grip strength (difference = 0.01 SD, 95% CI: -0.06, 0.08). However, treatment effects varied by recruitment cohort; although findings were not statistically significant, they suggest a clinically meaningful benefit (slower decline) in participants with faster rates of cognitive decline. CONCLUSIONS: These secondary results have direct relevance for inclusion in systematic reviews and meta-analyses. Future research should be designed to test whether hearing intervention can reduce short-term declines in physical function, particularly among those experiencing cognitive decline. Continuing follow-up of the ACHIEVE study participants will yield insights into longer-term (>3 years) effects of intervention.