76 | Chapter 5 Data collection and outcome measures Primary outcome measures The primary outcome measures were the number of falls and fall-related injuries over 12 months. A fall was defined as coming unintentionally to the ground or a lower level (236). These were assessed with fall diaries, including questions on the causes, circumstances and consequences of falls and monthly telephone calls for the follow-up on the fall diaries (1, 97). Secondary outcome measures Secondary outcome measures were assessed at three time points; at entry of the study (baseline, M0), after 4 months to determine the short-term effects (M4) and after 12 months to determine the long-term effects (M12). Demographic characteristics were assessed at M0. General health status was self-reported using the Physical Functioning domain and Emotional Wellbeing domain of the 36-Item Short Form Health Survey (SF-36) at M0, M4, and M12 (149) which was administered online or on paper based on the preferences of the participant. Both domains are on a scale of 0 to 100, where 0 represents the least and 100 the most favourable outcome (237). At each time point, we invited participants for physical tests and measurements to a location in their neighbourhood. The Four Stage Balance Test was used to assess static balance through four progressively challenging standing positions—feet together, semi-tandem, tandem, and single-leg stance—with the score ranging from 0 (lowest) to 40 (highest), based on the ability to hold each position for 10 seconds (238). The Timed Up and Go (TUG) test was used to measure functional mobility by timing how long it takes a person to stand up from a chair, walk three meters, turn around, walk back, and sit down, with lower times indicating better performance (239). The tests have a moderate (FSBT) to excellent (TUG and SF-36) reliability. Other measures Adherence to the In Balance intervention was monitored by keeping attendance lists by the In Balance therapists. Physical activity was assessed with an inertial sensor (DynaPort MoveMonitor Plus, McRoberts BV, The Netherlands) at M0, M4, and M12 (175, 176). The sensor was worn on the lower back for seven consecutive days, preferably day and night, except during water activities, and was returned afterwards by mail. The mean number of hours being physically active per day was determined.
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