Promoting activity, independence and stability in early dementia and mild cognitive impairment: the PrAISED research programme including an RCT

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HARWOOD, Rowan H, GOLDBERG, Sarah E, VAN DER WARDT, Veronika, BRAND, Andrew, BOOTH, Vicky, DI LORITO, Claudio, HOARE, Zoe, HANCOX, Jennie, BAJWA, Rupinder, BURGON, Clare, HOWE, Louise, COWLEY, Alison, BRAMLEY, Trevor, LONG, Annabelle, LOCK, Juliette, BOSCO, Alessandro, TUCKER, Rachael, ROBERTSON, Kate, WARD, Marie, WARD, Andrea, BECK, Lyndsay, HARLING, Martyn, 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 and MASUD, Tahir (2026). Promoting activity, independence and stability in early dementia and mild cognitive impairment: the PrAISED research programme including an RCT. Programme Grants for Applied Research, 14 (1), 1-63. [Article]

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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.

  1. 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.
  2. Three-arm feasibility randomised controlled trial to test research procedures, the practicality of intervention, and establish the need for prolonged supervision.
  3. Two-arm, multicentre randomised controlled trial, comparing intervention with control, with 15 months’ follow-up.
  4. Process and realist evaluations, including quantitative data, interviews and thematic analyses.
  5. Health economic evaluations, including a cost-effectiveness analysis using Markov modelling and social return on investment.
  6. 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.
More Information
Official URL:
https://doi.org/10.3310/plnv0118
Open Access URL:
https://njl-admin.nihr.ac.uk/document/download/204...
Open Access Version:
Published version

Identifiers

Identification Number:
10.3310/plnv0118
ORCID for Rowan H Harwood: ORCID iD orcid.org/0000-0002-4920-6718
ORCID for Sarah E Goldberg: ORCID iD orcid.org/0000-0001-5109-798X
ORCID for Veronika van Der Wardt: ORCID iD orcid.org/0000-0003-3995-7056
ORCID for Andrew Brand: ORCID iD orcid.org/0000-0002-6942-0404
ORCID for Vicky Booth: ORCID iD orcid.org/0000-0002-5338-0196
ORCID for Claudio Di Lorito: ORCID iD orcid.org/0000-0002-8953-0117
ORCID for Zoe Hoare: ORCID iD orcid.org/0000-0003-1803-5482
ORCID for Jennie Hancox: ORCID iD orcid.org/0000-0001-5938-5265
ORCID for Rupinder Bajwa: ORCID iD orcid.org/0000-0002-9551-2409
ORCID for Clare Burgon: ORCID iD orcid.org/0000-0002-4910-9969
ORCID for Louise Howe: ORCID iD orcid.org/0000-0002-0861-3042
ORCID for Alison Cowley: ORCID iD orcid.org/0000-0001-6858-475X
ORCID for Trevor Bramley: ORCID iD orcid.org/0000-0002-0553-7849
ORCID for Annabelle Long: ORCID iD orcid.org/0000-0003-2220-6774
ORCID for Juliette Lock: ORCID iD orcid.org/0000-0003-2028-6889
ORCID for Alessandro Bosco: ORCID iD orcid.org/0000-0002-2374-3427
ORCID for Rachael Tucker: ORCID iD orcid.org/0000-0001-8133-1909
ORCID for Kate Robertson: ORCID iD orcid.org/0000-0002-0922-3126
ORCID for Marie Ward: ORCID iD orcid.org/0000-0002-9606-0301
ORCID for Lyndsay Beck: ORCID iD orcid.org/0009-0007-2682-8526
ORCID for Martyn Harling: ORCID iD orcid.org/0000-0002-5082-410X
ORCID for Emma Adams: ORCID iD orcid.org/0000-0002-5444-6951
ORCID for Rebecca O’Brien: ORCID iD orcid.org/0000-0003-0300-8430
ORCID for Fiona Kearney: ORCID iD orcid.org/0000-0003-0081-5958
ORCID for Katarzyna Kowalewska: ORCID iD orcid.org/0000-0001-5018-9559
ORCID for Maureen Godfrey: ORCID iD orcid.org/0009-0008-4088-402X
ORCID for Marianne Dunlop: ORCID iD orcid.org/0000-0003-3734-9604
ORCID for Kehinde Junaid: ORCID iD orcid.org/0000-0001-5986-395X
ORCID for Simon Thacker: ORCID iD orcid.org/0000-0002-3203-1392
ORCID for Carol Duff: ORCID iD orcid.org/0000-0002-6810-1786
ORCID for Tomas Welsh: ORCID iD orcid.org/0000-0002-2619-5032
ORCID for Annette Haddon-Silver: ORCID iD orcid.org/0000-0002-6743-6496
ORCID for John Gladman: ORCID iD orcid.org/0000-0002-8506-7786
ORCID for Pip Logan: ORCID iD orcid.org/0000-0002-6657-2381
ORCID for Kristian Pollock: ORCID iD orcid.org/0000-0002-6836-8595
ORCID for Kavita Vedhara: ORCID iD orcid.org/0000-0002-9940-7534
ORCID for Victoria Hood: ORCID iD orcid.org/0000-0002-4738-2427
ORCID for Roshan Das Nair: ORCID iD orcid.org/0000-0001-8143-7893
ORCID for Helen Smith: ORCID iD orcid.org/0000-0003-0380-1420
ORCID for Rhiannon Tudor-Edwards: ORCID iD orcid.org/0000-0003-4748-5730
ORCID for Ned Hartfiel: ORCID iD orcid.org/0000-0001-9976-4294
ORCID for Victory Ezeofor: ORCID iD orcid.org/0000-0002-4211-8942
ORCID for Robert Vickers: ORCID iD orcid.org/0000-0002-3031-2940
ORCID for Martin Orrell: ORCID iD orcid.org/0000-0002-1169-3530
ORCID for Tahir Masud: ORCID iD orcid.org/0000-0003-1061-2898

Library

Publisher:
National Institute for Health and Care Research
Item Type:
Article
SWORD Depositor:
Symplectic Elements
Depositing User:
Symplectic Elements
Date record made live:
12 Mar 2026 12:16
Last Modified:
12 Mar 2026 12:30
Date of first compliant deposit:
12 March 2026
Date of first compliant Open Access:
12 March 2026
Version of first compliant deposit:
Version of Record
ISSN:
2050-4322
Page Range:
1-63
Volume:
14
URI:
https://shura.shu.ac.uk/id/eprint/37084
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