Abstract
Introduction
People living with dementia and MCI progressively lose abilities, through increasing cognitive impairment, co-morbidities, inactivity, acute illnesses and injuries. Rehabilitation therapy may reduce disability and falls and increase resilience.
Methods
We co-produced a therapy intervention, comprising strength, balance and dual-task exercises, functional activity training and promoting community access, providing up to 50 therapy sessions, delivered over 12 months and underpinned by a behaviour change strategy. We evaluated the intervention in a 5-site multi-centred Randomised Controlled Trial, against a brief assessment control. Participants had a diagnosis of dementia or MCI, Montreal Cognitive Assessment (MoCA) between 13 and 25. Primary outcome was the Disability Assessment in Dementia (DAD), an ADL score, after 12 months, alongside a battery of other health status measures. The COVID-19 pandemic necessitated modifications.
Results
We recruited 365 participants, 42% female. Median age was 81 years (range 65-95), MoCA 20 (13-26), DAD 82 (5-100). Baseline balance between groups was good. Participants were predominantly white and socioeconomically advantaged. Intervention group participants received a median of 31 (IQR 22-40) session and undertook and additional mean 121 minutes of exercise per week. Assessed fidelity was good. 290 (79%) were followed up. There were no significant differences in DAD score (adjusted mean difference -1.3/100, 95% CI -5.2 to +2.6; effect size (d) -0.06; -0.26 to 0.15; p=0.5), physical activity, balance, quality of life, cognition or a range of other measures. Upper 95% confidence intervals excluded even small benefits. Rate of falling reduced by 22% (Rate Ratio=0.78; 0.46 to 1.3; p=0.3), but this was not statistically significant.
Conclusions
The intensive PrAISED intervention did not improve measured outcomes. It may be impossible to reduce the rate of functional decline in dementia. Alternatively, the pandemic may have distorted outcomes or participants may have been too advantaged to benefit. There may have been unmeasured psycho-social benefits.