None listed
Conditions
Brief summary
This study will be a large randomised controlled trial that looks at the benefits of a multi-modal exercise intervention (i.e. balance and walking program) for people with mild cognitive impairment. The primary aim of this research is to determine whether a balance-focused multimodal exercise intervention improves physical health and quality of life; and reduces the rate of cognitive decline and falls for people with mild cognitive impairment. The secondary aim is to evaluate whether a balance-focused multimodal exercise program is cost-effective from a health care perspective.
Interventions
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 progressiv
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.
Sponsors
Elissa Burton
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
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 Rating (CDR) of (equal to) 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.
Exclusion criteria
Unstable medical condition, terminal illness, diagnosis of significant cognitive impairment and/or chronic mental illness (e.g. schizophrenia), severe sensory impairment affecting mobility, living in residential aged care, drinking more than 4 standard alcoholic drinks per day (i.e. >28/week), score >6 for the Geriatric Depression Scale-15 item (GDS-15) and lack of fluency in written and spoken English.
Outcome results
None listed