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Published in: Trials 1/2019

Open Access 01-12-2019 | Dementia | Study protocol

A randomised controlled trial of an exercise intervention promoting activity, independence and stability in older adults with mild cognitive impairment and early dementia (PrAISED) - A Protocol

Authors: Rupinder K. Bajwa, Sarah E. Goldberg, Veronika Van der Wardt, Clare Burgon, Claudio Di Lorito, Maureen Godfrey, Marianne Dunlop, Pip Logan, Tahir Masud, John Gladman, Helen Smith, Vicky Hood-Moore, Vicky Booth, Roshan Das Nair, Kristian Pollock, Kavita Vedhara, Rhiannon Tudor Edwards, Carys Jones, Zoe Hoare, Andrew Brand, Rowan H. Harwood

Published in: Trials | Issue 1/2019

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Abstract

Background

People with dementia progressively lose cognitive and functional abilities. Interventions promoting exercise and activity may slow decline. We developed a novel intervention to promote activity and independence and prevent falls in people with mild cognitive impairment (MCI) or early dementia. We successfully undertook a feasibility randomised controlled trial (RCT) to refine the intervention and research delivery. We are now delivering a multi-centred RCT to evaluate its clinical and cost-effectiveness.

Methods

We will recruit 368 people with MCI or early dementia (Montreal Cognitive Assessment score 13–25) and a family member or carer from memory assessment clinics, other community health or social care venues or an online register (the National Institute for Health Research Join Dementia Research). Participants will be randomised to an individually tailored activity and exercise programme delivered using motivational theory to promote adherence and continued engagement, with up to 50 supervised sessions over one year, or a brief falls prevention assessment (control). The intervention will be delivered in participants’ homes by trained physiotherapists, occupational therapists and therapy assistants. We will measure disabilities in activities of daily living, physical activity, balance, cognition, mood, quality of life, falls, carer strain and healthcare and social care use. We will use a mixed methods approach to conduct a process evaluation to assess staff training and delivery of the intervention, and to identify individual- and context-level mechanisms affecting intervention engagement and activity maintenance. We will undertake a health economic evaluation to determine if the intervention is cost-effective.

Discussion

We describe the protocol for a multi-centre RCT that will evaluate the clinical and cost-effectiveness of a therapy programme designed to promote activity and independence amongst people living with dementia.

Trial registration

ISRCTN, ISRCTN15320670. Registered on 4 September 2018.
Appendix
Available only for authorised users
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Metadata
Title
A randomised controlled trial of an exercise intervention promoting activity, independence and stability in older adults with mild cognitive impairment and early dementia (PrAISED) - A Protocol
Authors
Rupinder K. Bajwa
Sarah E. Goldberg
Veronika Van der Wardt
Clare Burgon
Claudio Di Lorito
Maureen Godfrey
Marianne Dunlop
Pip Logan
Tahir Masud
John Gladman
Helen Smith
Vicky Hood-Moore
Vicky Booth
Roshan Das Nair
Kristian Pollock
Kavita Vedhara
Rhiannon Tudor Edwards
Carys Jones
Zoe Hoare
Andrew Brand
Rowan H. Harwood
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3871-9

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