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.

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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, Vicky, BOOTH, Vicky, DAS NAIR, Roshan, POLLOCK, Kristian, VEDHARA, Kavita, EDWARDS, Rhiannon Tudor, JONES, Carys, HOARE, Zoe, BRAND, Andrew and HARWOOD, Rowan 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: 815. [Article]

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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.
More Information
Official URL:
https://doi.org/10.1186/s13063-019-3871-9
Uncontrolled Keywords:
Humans; Dementia; Exercise; Exercise Therapy; Follow-Up Studies; Feasibility Studies; Accidental Falls; Quality of Life; Aged; Aged, 80 and over; Caregivers; Cost-Benefit Analysis; Delivery of Health Care; Female; Male; Multicenter Studies as Topic; Postural Balance; Independent Living; Pragmatic Clinical Trials as Topic; Cognitive Dysfunction; Activities of daily living; Balance training; Cognitive impairment; Dementia; Dual-task training; Falls prevention; Occupational therapy; Physiotherapy; Strength training; Tailoring; Aged; Aged, 80 and over; Female; Humans; Male; Accidental Falls; Caregivers; Cognitive Dysfunction; Cost-Benefit Analysis; Delivery of Health Care; Dementia; Exercise; Exercise Therapy; Feasibility Studies; Follow-Up Studies; Independent Living; Multicenter Studies as Topic; Postural Balance; Pragmatic Clinical Trials as Topic; Quality of Life; 1102 Cardiorespiratory Medicine and Haematology; 1103 Clinical Sciences; Cardiovascular System & Hematology; General & Internal Medicine; 3202 Clinical sciences; 4202 Epidemiology; 4203 Health services and systems
Event Location:
England

Identifiers

Identification Number:
10.1186/s13063-019-3871-9
ORCID for Rupinder K Bajwa: ORCID iD orcid.org/0000-0002-9551-2409
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 Claudio Di Lorito: ORCID iD orcid.org/0000-0002-8953-0117
ORCID for Pip Logan: ORCID iD orcid.org/0000-0002-6657-2381
ORCID for Vicky Booth: ORCID iD orcid.org/0000-0002-5338-0196
ORCID for Carys Jones: ORCID iD orcid.org/0000-0001-6159-1842
ORCID for Zoe Hoare: ORCID iD orcid.org/0000-0003-1803-5482
ORCID for Rowan H Harwood: ORCID iD orcid.org/0000-0002-4920-6718

Library

Item Type:
Article
SWORD Depositor:
Symplectic Elements
Depositing User:
Symplectic Elements
Date record made live:
03 Apr 2025 13:41
Last Modified:
03 Apr 2025 13:45
Date of first compliant deposit:
2 January 2025
Date of first compliant Open Access:
3 April 2025
Version of first compliant deposit:
Author Accepted Manuscript
URI:
https://shura.shu.ac.uk/id/eprint/34636
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