Promoting Activity, Independence and Stability in Early Dementia and Mild Cognitive Impairment
NCT ID: NCT04065854
Last Updated: 2019-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
368 participants
INTERVENTIONAL
2018-10-01
2022-03-13
Brief Summary
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Detailed Description
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Who can participate? Patients aged 65 or over with early dementia or memory problems, recruited from memory clinics or the 'Join Dementia Research' register
What does the study involve? Participants are randomly allocated to either the control group or the intervention group. The control group receive standard brief falls assessment and advice, and up to two further visits if required. The intervention group receive an assessment, tailored strength and balance exercise programme, activity analysis and risk enablement advice, and assessment for environmental hazards. The intervention is delivered over 1 year in participants' own homes, and is tailored to individual interests, abilities and need for supervision. Participants are encouraged to exercise by themselves or with family members between visits, and once the programme ends. Researchers visit at the start of the study and after 12 months to measure ability in activities of daily living, activity, quality of life, memory and health service use. Participants complete monthly falls diaries over 15 months. The researchers conduct interviews and video record some therapy sessions to help understand how the programme works in practice.
What are the possible benefits and risks of participating? Some participants may benefit from taking part in the intervention, as exercise is generally known to be beneficial to health and well-being, including benefits to heart, blood pressure, diabetes, joints, mood and daily life. These participants may find that they are better able to do their daily activities. All participants and their relatives may enjoy having the researchers coming to visit them in their house. Some people appreciate having the opportunity to contribute to the well-being of others through research.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Web-based randomisation, using a dynamic adaptive algorithm, stratified for centre and other variables to 1) active intervention or 2) standard brief falls assessment and advice. An internal pilot trial will recruit the first 50 participants.
TREATMENT
NONE
Study Groups
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Control
The control group will receive standard brief falls assessment and advice.
No interventions assigned to this group
Intervention
Therapy intervention.
Intervention
Assessment, tailored strength and balance exercise programme, activity analysis and risk enablement advice, and assessment for environmental hazards. Tailored adherence support and supervision.
Interventions
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Intervention
Assessment, tailored strength and balance exercise programme, activity analysis and risk enablement advice, and assessment for environmental hazards. Tailored adherence support and supervision.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of MCI or dementia (of any subtype, except Dementia with Lewy Bodies i.e. Parkinson's Disease Dementia)
3. Have a carer or friend who knows the participant well (at least one hour a week contact over the phone, internet, or in person), and is willing and able to act as an informant
4. Able to walk without human help
5. Able to communicate in English
6. Able to see, hear and have dexterity sufficiently to perform neuropsychological tests
7. Have capacity to give consent to participate, and consenting to do so
Exclusion Criteria
2. Unavailable over the next year (e.g. plans to relocate or go on a long holiday, or has a life expectancy of less than a year)
65 Years
ALL
No
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
Nottingham University Hospitals NHS Trust
OTHER
Responsible Party
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Locations
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Derbyshire Healthcare NHS Foundation Trust
Derby, Derbyshire, United Kingdom
Lincolnshire Partnership NHS Foundation Trust
Lincoln, Lincolnshire, United Kingdom
Nottinghamshire Healthcare NHS Foundation Trust
Nottingham, Notts, United Kingdom
RICE - Research Institute for the Care of Older People
Bath, Somerset, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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PrAISED website
Other Identifiers
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17HC006
Identifier Type: -
Identifier Source: org_study_id
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