Balance on the Brain: A multi-modal exercise program for people with mild cognitive impairment

INTERVENTION: The Balance on the Brain study RCT is to be conducted between 2020 and 2024 in adults aged 50 years and over with mild cognitive impairment (MCI), with assessments at baseline (0 months), 6 and 12 months. The intervention group will receive a multi‐modal (balance and walking) program delivered by qualified physiotherapists in their home (one‐to‐one). The level of intensity will be individualised and assessed based on levels included within the intervention (ie levels on the app, which progressively increases over time as the participant improves and balance activities progressing from feet apart, to feet together to semi‐tandem and tandem stance and walk etc). The app being used in this project is called CY Research which can only be accessed by trial participants through a password. However, the Clock Yourself app which is almost identical is available on line for anyone to use. The participants will be guided in building up to 120 minutes of balance training per week and 150 minutes of walking. Strategies used to assess adherence will be the completion of a monthly calendar for physical activity and falls and a monthly phone call confirming physical activity and falls undertaken. We will evaluate the physical health, quality of life, cognition and falls rate during the 6‐month intervention and then the following 6‐months to determine whether it was maintained and had an effect. At the completion of the study data collection we will access health services data from the WA Dept Health data linkage service (approval received) and Service Australia (under review) to undertake the economic evaluation of the intervention. CONDITION: Mild cognitive impairment; ; Mild cognitive impairment Neurological ‐ Other neurological disorders PRIMARY OUTCOME: Balance: using the four square step test[The primary outcome will be measured at baseline, 6 months (post‐intervention, primary endpoint) and 12 months (post enrolment)] Falls: using a calendar and monthly phone calls[Falls rates will be measured monthly using a calendar and monthly phone calls and will be calculated (from baseline) at 6 (primary endpoint) and 12 months (post enrolment).] INCLUSION CRITERIA: Adults over 50 years of age, living in the community with a diagnosis of mild cognitive impairment, consistent with the Petersen criteria (Petersen R, Smith G, Ivnik R, Tangalos E, Kokmen E. Mild cognitive impairment: Clinical characterisation and outcome. Arch Neurol. 1999;56(3):303‐308), including self‐reported memory complaint, a Clinical Dementia Rating2 (CDR) of equal to or less then 0.5; and Standardised Mini‐Mental Status Examination (SMMSE) score of 24 or above. Other inclusion criteria are: not meeting Australian physical activity guidelines (ie <150 minutes of moderate intensity physical activity a week), not participating in balance training regularly (ie < twice a week) and absence of unstable disease precluding exercise. SECONDARY OUTCOME: Cognition: using the Montreal Cognitive Assessment (MoCA) tool[Measured at baseline, 6 (post‐intervention) and 12 (follow‐up) months] Physical activity: accelerometer data (e.g. time spent in sedentary, upright, sitting, standing and stepping, step count, stepping intensity and duration of activity) and the Physical Activity Scale for the Elderly (PASE)[Measured at baseline, 6 (post‐intervention) and 12 (follow‐up) months] Physical health: 6 Minute Walk Test (6MWT), [Measured at baseline, 6 (post‐intervention) and 12 (follow‐up) months] Physical health: Short Physical Performance Battery (SPPB)[Measured at baseline, 6 (post‐intervention) and 12 (follow‐up) months] Physical health: Timed‐Up‐and‐Go (TUG)[Measured at baseline, 6 (post‐intervention) and 12 (follow‐up) months] Quality of Life using the QoL‐AD tool[Measured at baseline, 6 (post‐intervention) and 12 (follow‐up) months] Secondary Falls outcome ‐ Falls injuries, assessed using a monthly calendar and monthly phone calls confirming the calendar data (ie gold standard for measuring falls data)[Measured at baseline, 6 (post‐intervention) and 12 (follow‐up) months] Secondary Falls outcome ‐ Fear of falling assessed using the Falls Efficacy Scale ‐ International.[Measured at baseline, 6 (post‐intervention) and 12 (follow‐up) months] Secondary Falls outcome ‐ Number of fallers, assessed using a monthly calendar and monthly phone calls confirming the calendar data (ie gold standard for measuring falls data)[Measured at baseline, 6 (post‐intervention) and 12 (follow‐up) months]