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van CCT (UK)

van CCT (UK)

Effects of a program combining walking and cognitive training on memory and behavior of older persons with dementia.

- candidate number10463
- NTR NumberNTR3121
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-okt-2011
- Secondary IDs2004/209 / P05.1284L MEC VUMC
- Public TitleEffects of a program combining walking and cognitive training on memory and behavior of older persons with dementia.
- Scientific TitleThe influence of combined physical training and face-name training on cognition in mild dementia.
- hypothesisA combined physical and face-name training is more effective on cognitive outcomes than the treatments separately.
- Healt Condition(s) or Problem(s) studiedDementia, Cognition, Walking, Face-name learning, Combined intervention
- Inclusion criteria1. Living in a nursing home;
2. Aged older than 70 years;
3. Having a diagnosis of dementia reported in the medical status;
4. Being able to walk with or without a walking aid. This will be measured with the Functional Ambulation Categories scale (FAC): FAC score of 3 or higher.
- Exclusion criteriaResidents will be excluded if they have any of the following:
1. A Mini-Mental State Examination score of 17 2. Visual disturbances precluding cognitive assessment;
3. Hearing difficulties precluding cognitive assessment;
4. History of alcoholism;
5. Personality disorders;
6. Cerebral trauma that resulted in loss of consciousness for >10 minutes;
7. Hydrocephalus;
8. Neoplasms;
9. Disturbances of consciousness;
10. Psychiatric disturbances (e.g. Schizophrenia);
11. Focal brain disorders.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2011
- planned closingdate1-nov-2014
- Target number of participants164
- InterventionsWalking has a positive influence on executive functioning in healthy older persons (Colcombe & Kramer 2003). In people with dementia reports on the effect of walking on executive functioning have not been consistent (Heyn e.a., 2004, Eggermont e.a., 2009) . A Cochrane review involving meta-analysis of nine randomized controlled trials of cognitive training did not find sufficient evidence to support a beneficial effect of cognitive training programs in people with dementia (Clare e.a. 2003, Clare & Woods, 2008). Nevertheless in some small studies concerning face-name learning (Clare e.a. 1999, 2002, Clare & Wilson, 2004, Dunn & Clare, 2007) beneficial effects on face-name association learning (memory) in people with mild dementia have been reported. Oswald e.a. (1996, 2006) showed that combined programs of physical exercise and cognitive training might be beneficial. In the present study separate and combined interventions involving walking and face-name learning will be applied to persons with dementia in order to determine the effects on executive functioning and memory in this group.

Participants will be randomized to one of 4 conditions:
1. Combined intervention including walking AND cognitive training (face-name learning);
2. Cognitive training (face-name learning);
3. Walking;
4. Social visits.

Trained students will apply the interventions 5 times per week for 6 weeks.

The 4 interventions in more detail:
1. Walking combined with cognitive training. First a walk of 30 minutes (including some conversation) and then training of face-name association learning for 30 minutes. The training method for face-name association learning is based on existing protocols (Clare et al, 1999; Clare et al, 2002; Dunn & Clare, 2007). Total duration of intervention is 60 minutes;
2. Cognitive training only: training of face-name association learning for 30 minutes + 15 min of conversation (social visit); total duration of intervention is 45 minutes;
3. Walking only: a walk of 30 minutes (including some conversation) + 15 minutes of conversation (social visit); total duration of intervention is 45 minutes;
4. Social visit only: conversation on social topics for 45 minutes, following list of themes and prompts or the interest of a client.

Baseline assessment (T1), follow-up assessment after 6 weeks (post assessment: T2) and second follow up assessment after 12 weeks (delayed assessment: T3) will determine the influence of the interventions on the performance of memory and executive function tests.
- Primary outcome1. Working memory: Digit span backward;
2. Verbal fluency: From the Groninger Intelligence Test (GIT) the "word fluency animals" and "word fluency occupations" subtests;
3. Inhibion: Stroop color-word test;
4. Memory: From the Rivermead Behavioural Memory Test (RBMT) the "faces recognition" and "picture recognition" subtests; from the Amsterdam Dementia-Screeningstest (ADS-6) the eight word test.
- Secondary outcome1. Global cognition: Mini-Mental State Examination (MMSE);
2. Frailty: Tilbuger Frailty Indicator (TFI);
3. Depressive symptoms: Geriatric Depression Scale (GDS-30);
4. Face-name learning data base;
5. Face recognition (free recall, visual recognition, verbal recognition);
6. Endurance: 6 minute walking test;
7. Strength: Sit to stand test;
8. Walking speed: Timed Up and Go (TUG), 6m walk test, 10m walk test.
- Timepoints1. Baseline measurement;
2. Post measurement after 6 weeks;
3. Follow up measurement after 12 weeks.

1-11-2011 Start with data collection;
1-11-2014 End of data collection;
From 2015 on: Analyzing results and writing scientific papers.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT for SCIENTIFIC QUERIESDrs. Martin Gennep, van
- Sponsor/Initiator Vrije Universiteit Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Vrije Universiteit Amsterdam, Avans University of Applied Science Breda, Thebe Breda
- PublicationsN/A
- Brief summaryThis study involves a multicenter, randomized, controlled single-blind study examining the effects of walking and face name learing separately and combined on cognitive functioning in older persons with mild dementia.
- Main changes (audit trail)
- RECORD21-okt-2011 - 21-nov-2011

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