|- candidate number||10463|
|- NTR Number||NTR3121|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-okt-2011|
|- Secondary IDs||2004/209 / P05.1284L MEC VUMC|
|- Public Title||Effects of a program combining walking and cognitive training on memory and behavior of older persons with dementia.|
|- Scientific Title||The influence of combined physical training and face-name training on cognition in mild dementia.|
|- hypothesis||A combined physical and face-name training is more effective on cognitive outcomes than the treatments separately.|
|- Healt Condition(s) or Problem(s) studied||Dementia, Cognition, Walking, Face-name learning, Combined intervention|
|- Inclusion criteria||1. 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 criteria||Residents 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;
9. Disturbances of consciousness;
10. Psychiatric disturbances (e.g. Schizophrenia);
11. Focal brain disorders.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2011|
|- planned closingdate||1-nov-2014|
|- Target number of participants||164|
|- Interventions||Walking 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);
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 outcome||1. 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 outcome||1. 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.
|- Timepoints||1. 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 site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. Martin Gennep, van|
|- CONTACT for SCIENTIFIC QUERIES||Drs. Martin Gennep, van|
|- Sponsor/Initiator ||Vrije Universiteit Amsterdam|
(Source(s) of Monetary or Material Support)
|Vrije Universiteit Amsterdam, Avans University of Applied Science Breda, Thebe Breda|
|- Brief summary||This 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)|
|- RECORD||21-okt-2011 - 21-nov-2011|