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

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

Abstract

© 2019 The Author(s). 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.

Citation

Bajwa, R. K., Goldberg, S. E., Van Der Wardt, V., Burgon, C., Di Lorito, C., Godfrey, M., Dunlop, M., Logan, P., Masud, T., Gladman, J., Smith, H., Hood-Moore, V., Booth, V., Das Nair, R., Pollock, K., Vedhara, K., Edwards, R. T., Jones, C., Hoare, Z., Brand, A., & Harwood, R. H. (2019). 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. Trials, 20(1), Article 815. https://doi.org/10.1186/s13063-019-3871-9

• Journal Article Type: Article
• Acceptance Date: Oct 31, 2019
• Online Publication Date: Dec 30, 2019
• Publication Date: Dec 30, 2019
• Deposit Date: Jan 7, 2020
• Publicly Available Date: Jan 8, 2020
• Journal: Trials
• Electronic ISSN: 1745-6215
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 20
• Issue: 1
• Article Number: 815
• DOI: https://doi.org/10.1186/s13063-019-3871-9
• Keywords: Medicine (miscellaneous); Pharmacology (medical)
• Public URL: https://nottingham-repository.worktribe.com/output/3683345
• Publisher URL: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3871-9
• Additional Information: Received: 9 August 2019; Accepted: 31 October 2019; First Online: 30 December 2019; : The protocol was approved by the Bradford Leeds Research Ethics Committee (Reference (CitationRef removed/YH/0059). All participants will provide written informed consent.; : Not applicable.; : The authors declare that they have no competing interests.