Promoting Activity, Independence and Stability in early dementia and mild cognitive impairment (PrAISED): A randomised controlled trial

Abstract

Background: Dementia is associated with frailty leading to increased risks of falls and hospitalisations. Interventions are required to maintain functional ability, strength and balance. Design: Multi-centre parallel group randomised controlled trial, with embedded process evaluation. Procedures were adapted during the COVID-19 pandemic. Participants: People with mild dementia or mild cognitive impairment (MCI), living at home, and a family member or carer. Objectives: To determine the effectiveness of an exercise and functional activity therapy intervention compared to usual care. Intervention: A specially-designed dementia-specific rehabilitation programme focussing on strength, balance, physical activity and performance of ADL, which was tailored, progressive, addressed risk and the psychological and learning needs of people with dementia, providing up to 50 therapy sessions over 12 months. The control group received usual care plus a falls risk assessment. Main outcome measure: The primary outcome was the informant-reported Disability Assessment for Dementia (DAD) 12 months after randomisation. Secondary outcomes were: self-reported ADL, cognition, physical activity, quality of life, frailty, balance, functional mobility, fear of falling, mood, carer strain and service use (at 12 months) and falls (between months 4 and 15). Results: 365 people were randomised, 183 to intervention and 182 to control. Median age of participants was 80 years (range 65-95), median Montreal Cognitive Assessment score 20/30 (range 13-26), 58% were men. Participants received a median of 31 (IQR = 22-40) therapy sessions out of a possible maximum of 50. Participants reported completing a mean 121 minutes/week of PrAISED activity outside of supervised sessions. Primary outcome data were available for 149 (intervention) and 141 (control) participants. There was no difference in DAD scores between groups: adjusted mean difference -1.3/100, 95% Confidence Interval (-5.2 to +2.6); Cohens d effect size -0.06 (-0.26 to +0.15); p=0.5. Upper 95% confidence intervals excluded small to moderate effects on any of the range of secondary outcome measures. Between months 4 and 15 there were 79 falls in the intervention group and 200 falls in the control group, adjusted incidence rate ratio 0.78 (0.5 to 1.3); p= 0.3. Conclusion: The intensive PrAISED programme of exercise and functional activity training did not improve ADLs, physical activity, quality of life, reduce falls or improve any other secondary health status outcomes even though uptake was good. Future research should consider alternative approaches to risk reduction and ability maintenance. Trial registration:ISRCTN15320670. Funding: National Institute for Health and Care Research

The facilitators and barriers to improving functional activity and wellbeing in people with dementia: A qualitative study from the Process Evaluation of Promoting Activity, Independence and Stability in Early Dementia

“…Participants recorded exercise on a monthly calendar and reported undertaking a mean of 121 minutes/week of PrAISED exercise. The RCT showed no measurable benefits in ADL, increased physical activity, quality of life or any other of the battery of health status measures studied [13].…”

“…The PrAISED RCT found that after 12 months, the Disability Assessment for Dementia (DAD) [21], and a range of other health status measures including balance, activity and quality of life were no different between intervention and control groups [13]. The aims of the process evaluation were to investigate the reception of the programme and explain findings from the RCT by identifying mechanisms, facilitators and barriers to achieving positive outcomes.…”

RCT-based Social Return on Investment (SROI) of a Home Exercise Program for People With Early Dementia Comparing In-Person and Blended Delivery Before and During the COVID-19 Pandemic

“…The study design for the PrAISED multi-center RCT has been previously reported, covering details such as the randomization method, sample size calculation, participant selection criteria, informed consent, and content of baseline and follow-up questionnaires. 12 …”

“…PrAISED (promoting activity, independence, and stability in early dementia) was a multi-center, pragmatic, randomized controlled trial (RCT), which was conducted between October 2018 and September 2022. 12 , 13 Patient participants were recruited from 5 locations in England and were randomized to a control group (usual care) or an intervention group (PrAISED). The intervention was a specifically designed rehabilitation program that provided a home-based exercise program along with promoting access to community activities for people with early dementia.…”

“…Patient participants in the PrAISED group were offered up to 50 therapy sessions over 12 months while those in the usual care group received an assessment modeled on usual falls prevention care which consisted of an initial visit and up to 2 further visits. 12 …”