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Background People with mild cognitive impairment (MCI) fall as often as people living with early dementia. Yet, few trials have investigated the effectiveness of fall prevention interventions for people with MCI. Recruitment of specific populations into long-term trials can be challenging, and to assist future studies, it is necessary to better understand more about trial recruitment. This study outlines the recruitment of people with MCI into the Balance on the Brain trial. This was a single-blind randomised controlled trial based in the Perth Metropolitan Area, which included people living with MCI in the community, aged 50 or over, and who were self-reported to not be meeting the Australian physical activity guidelines. The multi-modal exercise intervention was for 6 months, and all participants were followed up monthly for 12 months. A sample size of 396 was calculated to meet the requirements for the falls primary outcome (212 participants for the balance primary outcome). Methods Eleven recruitment strategies were used across the 36-month recruitment (January 2021 through to December 2023). Some recruitment strategies had costs, and these are also outlined. Results A total of 780 potential participants were initially prescreened, 258 completed full REDCap ® screening, and 128 people were recruited. Memory clinics/hospitals were the most successful recruitment source, followed by Facebook advertisements and radio. Discussion Recruiting people with MCI can be difficult, exacerbated in this study by the concurrent COVID-19 pandemic. Less restrictive inclusion criteria and multisite recruitment may provide greater success. Trials registration Australian New Zealand Clinical Trials Registry (ANZCTRN) ACTRN12620001037998. Registered on 12 October 2020.

IntroductionExercise and physical activity have been shown to improve cognition for people living with mild cognitive impairment (MCI). There is strong evidence for the benefits of aerobic exercise and medium evidence for participating in regular strength training for people with MCI. However, people living with MCI fall two times as often as those without cognitive impairment and the evidence is currently unknown as to whether balance training for people with MCI is beneficial, as has been demonstrated for older people without cognitive impairment. The aim of this study is to determine whether a balance-focused multimodal exercise intervention improves balance and reduces falls for people with MCI, compared with a control group receiving usual care.Methods and analysisThis single blind randomised controlled trial (Balance on the Brain) will be offered to 396 people with MCI living in the community. The multimodal exercise intervention consists of two balance programmes and a walking programme to be delivered by physiotherapists over a 6-month intervention period. All participants will be followed up over 12 months (for the intervention group, this involves 6-month intervention and 6-month maintenance). The primary outcomes are (1) balance performance and (2) rate of falls. Physical performance, levels of physical activity and sedentary behaviour, quality of life and cognition are secondary outcomes. A health economic analysis will be undertaken to evaluate the cost-effectiveness of the intervention compared with usual care.Ethics and disseminationEthics approval has been received from the South Metropolitan Health Service Human Research Ethics Committee (HREC), Curtin University HREC and the Western Australia Department of Health HREC; and approval has been received to obtain data for health costings from Services Australia. The results will be disseminated through peer-review publications, conference presentations and online platforms.Trial registration numberACTRN12620001037998; Australian New Zealand Clinical Trials Registry (ANZCTR).