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A service of the National Library of Medicine, National Institutes of Health. < Prev Next > Promoting activity, independence and stability in early dementia and mild cognitive impairment: the PrAISED research programme including an RCT Programme Grants for Applied Research, No. 14.01 Rowan H Harwood , Sarah E Goldberg , Veronika van Der Wardt , Andrew Brand , Vicky Booth , Claudio Di Lorito , Zoe Hoare , Jennie Hancox , Rupinder Bajwa , Clare Burgon , Louise Howe , Alison Cowley , Trevor Bramley , Annabelle Long , Juliette Lock , Alessandro Bosco , Rachael Tucker , Kate Robertson , Marie Ward , Andrea Ward , Lyndsay Beck , Martyn Harling , Emma Adams , Rebecca O’Brien , Fiona Kearney , Katarzyna Kowalewska , Maureen Godfrey , Marianne Dunlop , Kehinde Junaid , Simon Thacker , Carol Duff , Tomas Welsh , Annette Haddon-Silver , John Gladman , Pip Logan , Kristian Pollock , Kavita Vedhara , Victoria Hood , Roshan Das Nair , Helen Smith , Rhiannon Tudor-Edwards , Ned Hartfiel , Victory Ezeofor , Robert Vickers , Martin Orrell , and Tahir Masud . Author Information and Affiliations Authors Rowan H Harwood , 1 ,* Sarah E Goldberg , 1 Veronika van Der Wardt , 2,3 Andrew Brand , 4 Vicky Booth , 2 Claudio Di Lorito , 2 Zoe Hoare , 4 Jennie Hancox , 5 Rupinder Bajwa , 2 Clare Burgon , 2 Louise Howe , 2 Alison Cowley , 2 Trevor Bramley , 6 Annabelle Long , 2 Juliette Lock , 2 Alessandro Bosco , 7 Rachael Tucker , 1 Kate Robertson , 2 Marie Ward , 2 Andrea Ward , 8 Lyndsay Beck , 8 Martyn Harling , 9 Emma Adams , 1 Rebecca O’Brien , 1 Fiona Kearney , 10 Katarzyna Kowalewska , 2 Maureen Godfrey , 11 Marianne Dunlop , 11 Kehinde Junaid , 8 Simon Thacker , 12 Carol Duff , 13 Tomas Welsh , 14 Annette Haddon-Silver , 15 John Gladman , 2 Pip Logan , 2 Kristian Pollock , 1 Kavita Vedhara , 16 Victoria Hood , 6 Roshan Das Nair , 17,2 Helen Smith , 6 Rhiannon Tudor-Edwards , 18 Ned Hartfiel , 18 Victory Ezeofor , 18 Robert Vickers , 2 Martin Orrell , 19 and Tahir Masud 10 . Affiliations 1 School of Health Sciences, University of Nottingham, Queen’s Medical Centre, Nottingham, UK 2 School of Medicine, University of Nottingham, Queen’s Medical Centre, Nottingham, UK 3 Abteilung für Allgemeinmedizin, Präventive und Rehabilitative Medizin, Philipps-Universität Marburg, Marburg, Germany 4 North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, UK 5 School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK 6 Nottinghamshire Healthcare NHS Foundation Trust, South Nottinghamshire Place Based Partnership, Lings Bar Hospital, Nottingham, UK 7 Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK 8 Mental Health Services for Older People, Nottinghamshire Healthcare NHS Foundation Trust, Highbury Hospital, Nottingham, UK 9 College of Health, Psychology and Social Care, University of Derby, Derby, UK 10 Nottingham University Hospitals NHS Trust, Queen’s Medical Centre, Nottingham, UK 11 Patient and Public Involvement 12 Centre for Research and Development, Derbyshire Healthcare NHS Foundation Trust, Kingsway Hospital, Derby, UK 13 Lincolnshire Partnership NHS Foundation Trust, Welton house, Lime Kiln Way, Lincoln, UK 14 The Research Institute for the Care of Older People, Royal United Hospital, Bath, UK 15 Oxford Health NHS Foundation Trust, Research & Development, Warneford Hospital, Oxford, UK 16 Centre for Academic Primary Care, Lifespan and Population Health, University of Nottingham, Nottingham, UK 17 Stiftelsen for Industriell og Teknisk Forskning (SINTEF), Trondheim, Norway 18 Centre for Health Economics & Medicines Evaluation, College of Health and Behavioural Sciences, Bangor University, Bangor, UK 19 Institute for Mental Health, University of Nottingham, University of Nottingham, Nottingham, UK * Corresponding author ; Email: [email protected] Southampton (UK): National Institute for Health and Care Research ; 2026 Feb . Copyright and Permissions Copyright © 2026 Harwood et al. This work was produced by Harwood et al . under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/ . For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited. Search term Abstract Background: Dementia represents a major public health challenge worldwide. Interventions are required to maintain functional ability and prevent crises. Exercise-based therapy may improve activities of daily living and prevent falls. Objective: We aimed to systematically develop an intervention, called Promoting Activity, Independence and Stability in Early Dementia and mild cognitive impairment (PrAISED), and evaluate its clinical and cost-effectiveness. Design: A mixed-methods study. Literature review, co-design, patient and public involvement and practical experience were used to develop and refine a therapy intervention. We applied principles of behaviour change to promote engagement and motivation. Three-arm feasibility randomised controlled trial to test research procedures, the practicality of intervention, and establish the need for prolonged supervision. Two-arm, multicentre randomised controlled trial, comparing intervention with control, with 15 months’ follow-up. Process and realist evaluations, including quantitative data, interviews and thematic analyses. Health economic evaluations, including a cost-effectiveness analysis using Markov modelling and social return on investment. Implementation study. Setting: Therapy and research were undertaken in participants’ homes and local communities across 5 sites in England. Participants: People with diagnosed mild dementia or mild cognitive impairment, Montreal Cognitive Assessment score 13–25, living at home and a family member or carer. In the main trial, there were five sites in England, participants were 98% White ethnicity and 20% had mild cognitive impairment. Interventions: A specially designed, dementia-specific, rehabilitation programme focusing on strength, balance, physical activity and performance of activities of daily living, which was tailored, progressive and addressed risk, providing up to 50 therapy sessions over 12 months. The control group received usual care plus a falls risk assessment. Main outcome measures: The primary trial outcome was the informant-reported Disability Assessment for Dementia 12 months after randomisation. Secondary outcomes were: self-reported activities of daily living, physical activity, quality of life, frailty, balance, functional mobility, cognition, fear of falling, mood, carer strain and service use (at 12 months) and falls (between months 4 and 15). Results: Three hundred and sixty-five people were randomised in the multicentre trial, 183 to intervention and 182 to control. Median age of participants was 80 years (range 65–95), median Montreal Cognitive Assessment score was 20/30 (range 13–26) and 58% were men. Participants received a median of 31 (interquartile range = 22–40) therapy sessions out of a possible maximum of 50. Participants reported completing a mean 121 minutes/week of PrAISED activity. Primary outcome data were available for 149 (intervention) and 141 (control) participants. There was no difference in Disability Assessment for Dementia 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 secondary outcome measures. Between months 4 and 15, there were 79 falls in the intervention group and 200 falls in the control group, and adjusted incidence rate ratio was 0.78 (0.5 to 1.3); p = 0.3. Participants and therapists liked the intervention and thought that it produced health benefits. Tailoring, perceiving benefits, professional supervision and family or carer support were important facilitators. Cognitive and physical impairment, risk aversion and tapering the level of support were barriers. Therapeutic relationship between participant and therapist was important. The cost per quality-adjusted life-year gained was £130,000 over a lifetime horizon. Social return on investment was positive before the onset of the COVID-19 pandemic but was negative after the first pandemic lockdown, largely due to unavailability of access to community facilities. Limitations: The multicentre randomised controlled trial was disrupted by the COVID-19 pandemic. The first lockdown occurred when 301 participants had been randomised and 64 participants had completed the trial. Recruitment was suspended, and some therapy and data collection were undertaken remotely. The intervention was diminished compared with in-person delivery, but reported fidelity remained reasonable. Our participant population lacked socioeconomic and ethnic diversity – over 30% lived in the least deprived decile of postcodes. The intervention was very popular with participants and therapists, and it is possible that our predominantly biomedical and functionally orientated outcome variables failed to capture intervention benefits. Conclusions: The intensive PrAISED programme of exercise and functional activity training did not improve activities of daily living, physical activity, quality of life, reduce falls or improve any other secondary health status outcomes. Due to the pandemic, the population recruited, and the outcomes chosen, some uncertainty remains about the effectiveness of the intervention. Future work: Consider: (1) repeating the trial outside of a pandemic; (2) more psychosocial outcomes, such as social participation, affirming personhood and valuing therapeutic relationships; (3) alternative approaches to risk reduction and ability maintenance in dementia; (4) other models of support to manage problems associated with inevitable progression and decline; (5) that conventional randomised controlled trials may not be the best way to evaluate complex intervention for complex and degenerative conditions; interpretative and realist methods should supplement evaluation; and (6) work to include a wider range of ethnicities and socioeconomic circumstances. Study registration: This study is registered as ISRCTN10550694, 15320670. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-0614-20007) and is published in full in Programme Grants for Applied Research ; Vol. 14, No. 1. See the NIHR Funding and Awards website for further award information. Plain language summary Dementia causes deterioration in memory and thinking abilities. The Promoting Activity, Independence and Stability in Early Dementia (PrAISED) programme aimed to develop and test a physical exercise and activity intervention to improve the ability to do daily activities among older people in the early stages of dementia. We developed a therapy programme specifically designed for people with dementia. We paid particular attention to encouraging participation. Therapy was tailored to participants’ goals, preferences and abilities. We confirmed that we could deliver the intervention and do the research to test it in a small-scale feasibility study. We tested PrAISED by recruiting 365 people with dementia and a family member from five English counties. We randomly assigned them to receive PrAISED therapy or to a control group, who were given advice on falls prevention. The PrAISED group received up to 50 therapy sessions, delivered by trained therapists, and were also encouraged to do exercises on their own. At the start and after 12 months, we measured ability to do everyday activities and other aspects of health, including falls, quality of life, activity and National Health Service and social care use. We did interviews and observations to explain the findings. Those receiving PrAISED therapy did no better on any of our measurements than those in the control group. The therapy programme was popular, and participants described benefits to their lives. Professional supervision and family support were important. However, memory and physical health problems often prevented full participation. The study was disrupted by the COVID-19 pandemic. An economic study showed that PrAISED was not cost-effective. A method which values social outcomes suggested that PrAISED gave a good return before the pandemic but not during it. We conclude that it might be more appropriate to help people manage problems associated with the inevitable decline seen in dementia rather than to try to change the course of the disease. Contents Expand All Collapse All Scientific summary Synopsis Introduction and background Programme aims and objectives Work package summaries Conclusions Additional information References Appendix 1. Summaries of unpublished papers Appendix 2. Summaries of unpublished papers List of abbreviations List of supplementary material Expand All Collapse All About the Series Programme Grants for Applied Research ISSN (Electronic): 2050-4330 Article history The research reported in this issue of the journal was funded by PGfAR as award number RP-PG-0614-20007. The contractual start date was in March 2016. The draft manuscript began editorial review in January 2024 and was accepted for publication in July 2025. As the funder, the PGfAR programme agreed the research questions and study designs in advance with the investigators. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The PGfAR editors and production house have tried to ensure the accuracy of the authors’ manuscript and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this article. Last reviewed: January 2024; Accepted: July 2025. Copyright © 2026 Harwood et al . This work was produced by Harwood et al . under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/ . For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited. Bookshelf ID: NBK620708 PMID: 41704107 DOI: 10.3310/PLNV0118 < Prev Next > Share Views PubReader Print View Cite this Page Harwood RH, Goldberg SE, van Der Wardt V, et al. Promoting activity, independence and stability in early dementia and mild cognitive impairment: the PrAISED research programme including an RCT. Southampton (UK): National Institute for Health and Care Research; 2026 Feb. (Programme Grants for Applied Research, No. 14.01.) doi: 10.3310/PLNV0118 PDF version of this title (3.2M) Other titles in this collection Programme Grants for Applied Research Related information NLM Catalog Related NLM Catalog Entries Recent Activity Clear Turn Off Turn On Promoting activity, independence and stability in early dementia and mild cognit... Promoting activity, independence and stability in early dementia and mild cognitive impairment: the PrAISED research programme including an RCT Your browsing activity is empty. Activity recording is turned off. Turn recording back on See more... 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