The effectiveness of a nation-wide implemented fall prevention intervention in the Netherlands in reducing falls and fall-related injuries among community-dwelling older adults with an increased risk of falls: a randomized controlled trial

Background: Fall prevention programs have been proven effective in reducing falls and fall-related injuries in specific target groups and settings. However, implementing these programs on a larger scale often requires adjustments for feasibility. This study assessed the effectiveness of the nationally implemented In Balance fall prevention intervention compared to usual care in community-dwelling older adults. Methods: In this single-blinded randomized controlled trial, 264 non- and pre-frail adults of 65 years or older with an increased fall risk were recruited from eleven centers. The intervention group followed an adapted nation-wide 14-week group In Balance program, including educational sessions and Tai Chi-based balance and strength exercises, delivered by trained therapists. The control group received general physical activity recommendations. Primary outcomes were the number of falls and fall-related injuries over 12 months, recorded via fall diaries and follow-up calls. Secondary outcomes included balance, mobility, and general health. Data were analysed using generalized linear- and mixed-effects models, with multiple imputation for missing data. To obtain a difference in the number of falls per year between the intervention and control groups of 50%, 106 participants per group were required, increased to 264 to account for dropout. Results: The mean age was 75.2 (SD 5.6) years in the intervention and 75.7 (SD 5.1) years in the control group (p > 0.05). The mean number of falls per person over 12 months was not statistically different between the intervention and control group (1.67 (SE 0.24) and 1.98 (0.37), respectively; incidence rate ratio 0.85 (95% CI 0.51–1.43)), nor the mean number of fall-related injuries (0.70 (SE 0.11) and 0.97 (0.18), respectively; incidence rate ratio 0.73 (95% CI 0.44–1.19)). Secondary outcomes also showed no significant differences between groups, frailty status and over time. Attendance averaged 15.5 of 24 sessions. Conclusions: The adapted In Balance program did not significantly reduce falls, injuries, or improve secondary outcomes compared to usual care. The implemented In Balance program appears to be less effective than a priori assumed, possibly due to limited adherence in practice or insufficient frequency and duration of the program. Trial registration: Research with human participants: NL9248 (registered February 13 2021, URL: https://www.onderzoekmetmensen.nl/nl/trial/26195).