5 The effectiveness of a nation-wide implemented fall prevention intervention in the Netherlands | 75 past 6 months, if they were unable to read and understand Dutch, if they had cognitive impairment defined as a score lower of 18 or lower on the Mini-Mental State Examination (104), or if they had any self-reported uncontrolled comorbid conditions or contraindications for executing the physical exercises that are part of the In Balance intervention (e.g., cardiovascular, neurological and orthopaedic problems). The study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the Medical Ethical Committee Brabant (project number P2055) on 10 February 2021. All participants signed informed consent and were aware that participation is voluntary. Recruitment, randomization, stratification, blinding and treatment allocation Participants were recruited through flyers, advertisements in local newspapers, and the network of In Balance therapists. Randomization was conducted in a 1:1 ratio between the intervention and control groups, with stratification based on frailty status. The allocation sequence was generated online via Sealed Envelope by MvG. To ensure randomization, sealed envelopes were prepared in blocks of 10, with five envelopes per group. One of the researchers assigned participants to a group by opening a sealed envelope. All investigators and assessors involved in the study remained blinded to group assignment. However, due to the nature of the study, blinding of participants and therapists was not possible. Intervention and control group The In Balance intervention is a fourteen-week group intervention for older adults at risk of falls and was provided by registered and certified physical therapists and exercise therapists (151). The intervention consists of three phases. The first phase (week 1) comprises one information meeting. In the second phase (week 2-4), there are three weekly educational meetings. The third phase (week 5-14) consists of a physical exercise programme with two one-hour training sessions per week. Exercises integrate principles of Tai Chi, focusing on balance and strength. For a more elaborate description of the In Balance intervention, see Appendix 1 and the study protocol of this study (198). The control group was provided with a flyer containing general physical activity recommendations based on the World Health Organization’s guidelines (90). This flyer provides guidance on physical activity, strength, and balance for older adults.
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