42 | Chapter 3 In 2006, Faber and colleagues demonstrated that the 20-week In Balance intervention resulted in a fall-risk reduction of 61% in pre-frail older adults, compared to usual care in a residential care setting, whereas in frail older adults the risk of becoming a faller increased considerably (55). This difference in effect may be because frail participants were not able to perform the exercises as effectively as the pre-frail group (142). Based on the positive findings in the pre-frail group, the In Balance fall prevention programme has been widely implemented in the Netherlands by certified therapists. After implementation, the target group was extended to a group mainly consisting of independently living older adults. Moreover, the duration of the intervention was shortened from twenty to fourteen weeks, for practical reasons and adherence, based on indications that the largest physical improvements in the study by Faber and colleagues were seen in this initial period (55). Considering the adjustments in both duration and target population of the original In Balance intervention, re-evaluation of the effectiveness of the intervention is urgently needed. Moreover, evidence on the cost-effectiveness of fall prevention programmes is scarce (143). Cost-effectiveness analysis of the In Balance intervention would allow insurance companies, policy- and decision makers to allocate health resources efficiently. Therefore, this study aims to assess the effectiveness and cost-effectiveness from a societal perspective of the In Balance fall prevention intervention compared to written general physical activity recommendations on the number of falls with and without injuries for community-dwelling adults of 65 years or older with an increased fall risk, stratified for frailty status (non-frail and pre-frail). METHODS Study design and setting This study is a single-blinded, multicenter randomized controlled trial with stratification on frailty levels. The design of the trial follows the recommendations of the Standard Protocol Items: Recommendations for Interventional Trials 2013 Checklist (144). The study intervention will be executed by trained, certified and registered physical- and exercise therapists in several municipalities in the Netherlands. Vrije Universiteit Amsterdam is the sponsor of this study. Participants The target population consists of community-dwelling older adults (aged ≥ 65 years) with an increased risk of falls according to the fall risk screening questionnaire (145-147). All participants should be able to independently execute activities of daily living (e.g., going to the bathroom, dressing and undressing) and walk 100 meter. Older adults will be included if they are classified as non-frail or pre-frail based on the phenotype concept introduced by
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