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

Harwood, Rowan H; Goldberg, Sarah E; Brand, Andrew; van Der Wardt, Veronika; Booth, Vicky; Di Lorito, Claudio; Hoare, Zoe; Hancox, Jennie; Bajwa, Rupinder; Burgon, Clare; Howe, Louise; Cowley, Alison; Bramley, Trevor; Long, Annabelle; Lock, Juliette; Tucker, Rachael; Adams, Emma; O’Brien, Rebecca; Kearney, Fiona; Kowalewska, Katarzyna; Godfrey, Maureen; Dunlop, Marianne; Junaid, Kehinde; Thacker, Simon; Duff, Carol; Welsh, Tomas; Haddon-Silver, Annette; Gladman, John; Logan, Pip; Pollock, Kristian; Vedhara, Kavita; Hood, Victoria; Das Nair, Roshan; Smith, Helen; Tudor-Edwards, Rhiannon; Hartfiel, Ned; Ezeofor, Victory; Vickers, Robert; Orrell, Martin; Masud, Tahir

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); Cohen’s 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.

Citation

Harwood, R. H., Goldberg, S. E., Brand, A., van Der Wardt, V., Booth, V., Di Lorito, C., Hoare, Z., Hancox, J., Bajwa, R., Burgon, C., Howe, L., Cowley, A., Bramley, T., Long, A., Lock, J., Tucker, R., Adams, E., O’Brien, R., Kearney, F., Kowalewska, K., …Masud, T. Promoting Activity, Independence and Stability in early dementia and mild cognitive impairment (PrAISED): A randomised controlled trial

• Working Paper Type: Working Paper
• Deposit Date: Jun 28, 2024
• Publicly Available Date: Jul 8, 2024
• Public URL: https://nottingham-repository.worktribe.com/output/15169706
• Publisher URL: https://www.medrxiv.org/content/10.1101/2022.12.20.22283699v2