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Effects of a physical activity program and movement-focused care on dependence in daily functions, cognition, physical functions, quality of life related outcomes, and use of medication in nursing home residents with dementia.


- candidate number23598
- NTR NumberNTR5641
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-jan-2016
- Secondary IDsVCWE-2015-183R1 METc VUmc protocol 2015.446
- Public TitleEffects of a physical activity program and movement-focused care on dependence in daily functions, cognition, physical functions, quality of life related outcomes, and use of medication in nursing home residents with dementia.
- Scientific TitleEffects of a physical activity program and movement-focused care on activities of daily living, cognition, physical functions, quality of life related outcomes, and use of psychotropic drugs in nursing home residents with dementia: a randomized controlled trial.
- ACRONYM
- hypothesis1.The physical activity program and movement-focused care have beneficial effects on independence in activities of daily living in nursing home residents with dementia.
2.The physical activity program and movement-focused care have beneficial effects on cognition, physical function, quality of life related outcomes, and the use of psychotropic drugs in nursing home residents with dementia.
- Healt Condition(s) or Problem(s) studiedDementia, Physical activity
- Inclusion criteriaInclusion criteria:
1. Living on a psychogeriatric ward of stichting tanteLouise-Vivensis
2. Diagnosis of dementia (as stated in the medical status of the person)
3. Mini-Mental State Examination (MMSE) score: at least 5 and a maximum of 24
4. Age: at least 65 years
5. Ability to complete the six-minute walking test independently, with or without a walking aid.
- Exclusion criteriaExclusion criteria:
1. Wheelchair bound
2. Severe visual problems
3. Severe cardiovascular problems
4. Instable diabetes mellitus
5. Severe behavioural problems
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 20-jan-2016
- planned closingdate20-jan-2017
- Target number of participants120
- InterventionsIn the present study, there are two interventions:
1. Physical activity program: combined strength and aerobic training with a duration of 6 months, 3 times a week for 30 minutes.
2. Movement-focused care: nursing staff and paramedics are trained to stimulate physical activity and independence during daily activities.

Separate and combined interventions will be applied leading to four conditions:
1. Combined intervention: physical activity program and movement-focused care
2. Physical activity program
3. Movement-focused care
4. Control: tea and coffee moments
- Primary outcomeActivities of daily living (ADL): Care Dependency Scale (CDS) and the performance-based Erlangen ADL (E-ADL)
- Secondary outcomeCognition:
- General cognitive functioning: Severe Impairment Battery (SIB) short version
- Executive functioning (set-shifting, response inhibition, working memory): Category fluency tests (subtest GIT), Digit span (subtest of WAIS-III), subtests of the Frontal Assessment Battery (FAB; ‘conflicting instructions' and ‘go-no go’)

Physical function:
- Endurance: six minute walking test (6MWT)
- Strength: chair stand test, Jamar dynamometer
- Functional mobility: timed up and go (TUG)
- Balance: figure of eight walk test (FoE), Figure and Injuries: Cooperative Studies of Intervention Techniques (FICSIT-4)

Use of psychotropic drugs: derived from the medical charts

Quality of life related outcomes:

* Quality of life: Qualidem
* Mood and behaviour:
- Depression: Cornell Scale for Depression in Dementia (CSDD)
- Apathy: Apathy Evaluation Scale-10 (AES-10)
- Agitation: Cohen-Mansfield Agitation Inventory (CMAI)

* Rest-activity rhythm: actigraphy
- TimepointsThere are three time-points:
1. Baseline measurement;
2. Halfway through the intervention (12 weeks);
3. Post-intervention (24 weeks).
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc I.M. Nauta
- CONTACT for SCIENTIFIC QUERIESMSc I.M. Nauta
- Sponsor/Initiator Vrije Universiteit Amsterdam, Stichting tanteLouise-Vivensis
- Funding
(Source(s) of Monetary or Material Support)
Stichting tanteLouise-Vivensis
- Publications
- Brief summaryThis randomized controlled trial aims to examine the effects a physical activity program and movement-focused care on activities of daily living, cognition, physical functions, quality of life related outcomes, and use of psychotropic drugs in nursing home residents with dementia
- Main changes (audit trail)Amendement 21-jun-2016:
CHANGE:
Inclusion criteria:
3. Mini-Mental State Examination (MMSE) score: 1 - 24
CHANGE: Secondary Outcomes
Cognition:
- General cognitive functioning: Severe Impairment Battery (SIB) short version, MMSE (MMSE is not assessed at 3 months, only at baseline and six months)
- For participants with a MMSE of 5 or higher: Executive functioning (set-shifting, response inhibition, working memory): Category fluency tests (subtest GIT), Digit span (subtest of WAIS-III), subtests of the Frontal Assessment Battery (FAB; ‘conflicting instructions' and ‘go-no go’)
- RECORD12-jan-2016 - 22-jun-2016


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