3 Protocol for the In Balance randomized controlled trial | 49 Table 3.2. Overview of enrolment, intervention, outcome measurements and time of assessments PS M0 W14 M4 M8 M12 Enrolment Recruitment x Eligibility screening x Informed consent x Allocation x Intervention In Balance or written physical activity recommendations Outcomes Number of falls and fall-related injuries Number, causes, circumstances and consequences of falls and fall-related injuries Demographic characteristics Age, sex, height, weight, marital status, living situation, work, smoking, falling, use of walking aids, experience with fall prevention interventions, walking, balance, physical activity, use of medication and presence of chronic diseases x x Frailty Phenotype concept by Fried et al. x x Physical performance Balance, mobility, muscle strength, walking speed, aerobic endurance, perceived fatigue, fall risk x x x Physical activity Inertial sensor for 7 consecutive days x x x Questionnaires General health status, empowerment, fear of falling, walking confidence x x x Cost-effectiveness questionnaires Quality of life, healthcare, participant, family and productivity costs x x x Process evaluation Expectations and experiences with the In Balance intervention x PS: prior to study, M0: baseline measurement (pre-intervention), W14: 14 weeks after start of the intervention, M4: 4 months after start of the intervention, M8: 8 months after start of the intervention, M12: 12 months after start of the intervention. Data management Every participant will receive a computer-generated unique identification code at baseline. All data will be collected pseudonymised using this identification code. In the data management system, test results from baseline and post intervention assessments will be collected as well as the documentation on each training session, and for each identification code a digital logbook will be kept in the data management system. To improve data quality, a trained
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