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The effects of observation of walking on physical, cognitive, and quality of life related outcomes in older adults with dementia


- candidate number19221
- NTR NumberNTR4708
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-jul-2014
- Secondary IDs60-61700-98-023 / 32 030 0003. AAL-project
- Public TitleThe effects of observation of walking on physical, cognitive, and quality of life related outcomes in older adults with dementia
- Scientific TitleThe effects of observation of walking in a living room environment, on physical, cognitive, and quality of life related outcomes in older adults with dementia: a randomized controlled trial
- ACRONYM
- hypothesis1. The observation of videos of walking people has a beneficial effect on the amount of physical activity and on physical performance in older adults with dementia
2. The observation of videos of walking people has beneficial effects on cognition and quality of life related outcomes in older adults with dementia
- Healt Condition(s) or Problem(s) studiedDementia
- Inclusion criteria- Having a diagnosis of dementia (as stated in the medical status of the person)
- MMSE score of 15-25, or a lower score
- Age: at least 70 years
- Exclusion criteria- History of alcoholism
- Cerebral trauma
- Hydrocephalus
- Visual impairments
- Neoplasm
- History of depression
- Personality disorders, other than those based on dementia
- Disturbances of consciousness
- Not being ambulant
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2013
- planned closingdate31-jul-2015
- Target number of participants199
- InterventionsThis is a 3-month intervention in which videos are shown to an experimental group (videos of walking people), and to a control group (videos of nature). These videos are shown on two TV screens in the living rooms of residential care facilities, and are shown during the whole day on weekdays.
- Primary outcomePhysical activity:
- Parameter M10, Actiwatch (AW)2

Physical performance:
- Timed Up & Go test
- 4-Meter Walking Speed test
- Sit to Stand test
- For the gait pattern: sensors, EXLs1
- For ADL: Katz index
- Secondary outcomeCognition:
- Mini-Mental State Examination
- Eight words test (subtest ADS)*
- Picture completion (subtest GIT)
- Letter fluency test*
- Digit span (subtest WAIS-III)
- Face recognition and Picture recognition (subtest RBMT)*
- Category fluency tests (subtest GIT)
- Visual memory span (subtest WMS)*

* indicates that the test is administered only for participants with an MMSE score of 15-25

Quality of life related outcomes:
- DQoL
- QUALIDEM
- For depression: Cornell Scale for Depression in Dementia
- For the rest-activity rhythm: Actiwatch (AW)2
- TimepointsThere are four timepoints for the test administrations: baseline (T1; week 0), halfway through the intervention (T2; week 7), post-intervention (T3; week 13), and follow-up (T4; week 19).
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc. J.G. Douma
- CONTACT for SCIENTIFIC QUERIESMSc. J.G. Douma
- Sponsor/Initiator Vrije Universiteit Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Ambient Assisted Living Joint Program (AAL)
- Publications
- Brief summaryThis randomized controlled trial aims to examine the effects of observation of walking on physical, cognitive, and quality of life related outcome measures in older adults with dementia, residing in residential care facilities.
- Main changes (audit trail)
- RECORD31-jul-2014 - 8-sep-2014


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