Balance on the Brain: a randomised controlled trial evaluating the effect of a multimodal exercise programme on physical performance, falls, quality of life and cognition for people with mild cognitive impairment—study protocol

Abstract

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).

Prevalence, risk factors and effectiveness of falls prevention interventions for adults living with Mild Cognitive Impairment in the community: A systematic review and meta-analysis

“…The Balance on the Brain randomized controlled trial is currently in progress and is trialling the effectiveness of balance interventions in reducing falls for people with Mild Cognitive Impairment. 79 These type of studies are important. They will assist health professionals in rehabilitation settings to better understand and design preventive and post-fall interventions for people with Mild Cognitive Impairment (with the aim of reducing future falls).…”

Associations between physical activity, sedentary behaviour and cognitive domain performance of people living with mild cognitive impairment in the community

“…Participants were recruited as part of the Balance on the Brain randomised controlled trial (RCT) between January 2021 to December 2022. The RCT is recruiting participants across the Perth and Rockingham metropolitan areas of Western Australia (WA) to evaluate the effect of multi-modal exercise on improving balance and reducing falls (Burton et al, 2022). The cross-sectional design included baseline data from all participants in the RCT before the intervention.…”

Association between mild cognitive impairment and falls among Chinese older adults: the mediating roles of balance capacity and depressive symptoms

“…The possible physiological and psychological mechanisms by which MCI is associated with falls have been mentioned in several studies. On the one hand, previous study emphasised older adults with MCI showed worse balance capacity (eg, increased anterior–posterior and mediolateral sway) 14 15. Impaired balance capacity indicates difficulty with neurological and musculoskeletal functions that contribute to physical stability 16.…”

“…There are many studies demonstrated that MCI is significantly associated with falls 9 14. The possible physiological and psychological mechanisms by which MCI is associated with falls have been mentioned in several studies.…”

“…Impaired balance capacity indicates difficulty with neurological and musculoskeletal functions that contribute to physical stability 16. With the increasing severity of MCI, there is a deterioration in balance capacity and a sharp rise in the risk of falls 14. On the other hand, MCI could increase the risk of mood disorders (eg, poor attention and orientation, anxiety and depressive symptoms),17 which also contribute to high risks of falls.…”