Back to Search
Start Over
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.
- Source :
-
Trials [Trials] 2019 Dec 30; Vol. 20 (1), pp. 815. Date of Electronic Publication: 2019 Dec 30. - Publication Year :
- 2019
-
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.<br />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.<br />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.<br />Trial Registration: ISRCTN, ISRCTN15320670. Registered on 4 September 2018.
- Subjects :
- Aged
Aged, 80 and over
Female
Humans
Male
Accidental Falls prevention & control
Caregivers
Cost-Benefit Analysis
Delivery of Health Care methods
Exercise
Feasibility Studies
Follow-Up Studies
Multicenter Studies as Topic
Postural Balance
Pragmatic Clinical Trials as Topic
Quality of Life
Cognitive Dysfunction therapy
Dementia therapy
Exercise Therapy methods
Independent Living psychology
Subjects
Details
- Language :
- English
- ISSN :
- 1745-6215
- Volume :
- 20
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Trials
- Publication Type :
- Academic Journal
- Accession number :
- 31888709
- Full Text :
- https://doi.org/10.1186/s13063-019-3871-9