44 | Chapter 3 Recruitment, randomization, blinding and treatment allocation Recruitment will be done via flyers, advertisements in local papers, folders distributed through supermarkets, pharmacists, community centres, general practitioners, at annual flu shots, and via personal invitations by In Balance therapists and general practitioners. Participants will be randomized into the intervention group or the control group using block-randomization to balance the size of the two groups. Randomization will be stratified according to frailty. We aim to include 30-50% of the participants in the pre-frail subgroup and 50-70% in the non-frail subgroup in both the intervention and control group. As soon as one of the subgroups starts to outnumber the other subgroup, we will only target the underrepresented subgroup for recruitment. Two hundred fifty-six sealed envelopes in blocks of 10 (5 envelopes per group) will be prepared by an independent investigator. These sequentially numbered envelopes contain a random computer-generated unique identification number. A second matching envelope contains the group information. All investigators and assessors involved in this study will be blinded to group assignment until completion of statistical analyses. Due to the nature of this study, participants and therapists cannot be blinded to group allocation. Participants will be informed orally about their allocation and therapists will receive the names of those participants who will participate in the In Balance intervention. Informed consent When potential participants have shown interest to participate in the study by contacting one of the investigators, they will first be interviewed by telephone on their eligibility according to the in- and exclusion criteria. Eligible participants will receive an extended information letter via mail or email, in which the study procedures, including randomization, will be explained. All potential participants will be given at least one week to consider participation and to approach the investigator for questions. Eligible participants will be contacted by phone and asked whether they want to participate in the study and whether they are willing to be randomized. When eligible participants agree to participate, they are invited to come to a location in the municipality of the participant and give their informed consent for participation in the study. Next, participants will be screened on cognition and frailty according to the criteria of Fried et al. and if they have a score of 19 points or higher on the Mini-Mental State Examination and are classified as non- or pre-frail, the baseline assessment will be conducted (29). Intervention The In Balance intervention is a fourteen-week group programme for older adults at risk of falls and will be provided by registered and certified physical therapists and exercise therapists (151). The aim of the intervention is to reduce falls by increasing awareness, balance and strength by combining educational and exercise components. The intervention consists of three phases. The first phase (week 1) comprises one information meeting about physical
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