Trial document





This trial has been registered retrospectively.
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  DRKS00005194

Trial Description

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Title

NEUROvitalis Plus: cognitive training effects of a neuropsychological program in combination with a physical training and nutrition education

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Trial Acronym

NV+ Study

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URL of the Trial

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Brief Summary in Lay Language

Healthy aging is commonly accompanied by a decline in several cognitive/mental functions. These alterations are one of the most feared aspects of aging. Appropriate prevention strategies to slow down cognitive aging may not only improve well-being of healthy elderly but also reduce economic costs due to increasing prevalence (= quantity of disease) of dementias.
There is evidence that physical activity and cognitive/mental activity can lead to cognitive/mental enhancement, but although first studies examining the combination of these strategies are promising and synergistic (= strategies acting together) effects are possible, this topic has rarely been studied. Furthermore there is evidence from a few studies that individualized physical activity could enhance cognitive/mental functions. In terms of the fitness status, healthy elderly often show a lot of heterogeneity. So it seems reasonable to adapt the physical activity to their fitness status. Due to this adoption a stronger effect on the physical and therefore cognitive/mental improvement could be expected.
The planned study compares three different arms of training groups for healthy elderly (NEUROvitalis as single cognitive/mental training vs. NEUROvitalis Plus as combined cognitive/mental and physical training vs. NEUROvitalis Plus Single as combined cognitive/mental and individualized physical training).

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Brief Summary in Scientific Language

The study is planned as a randomized controlled trial and with N=90 healthy elderly. The aim is to investigate three arms of a cognitive training, two of that are combined with physical activity (NEUROvitalis as single cognitive training vs. NEUROvitalis Plus as combined cognitive and physical training vs. NEUROvitalis Plus Single as combined cognitive and individualized physical training). The hypothesis is that the combination of cognitive and physical activity can lead to stronger cognitive training effects than cognitive training alone does. Furthermore the hypothesis will be examined if a cognitive training combined with individualized physical activity has more effects on cognition than the two other groups. Besides cognitive, physical and other health-relevant outcome variables neurophysiological parameters will be analyzed by blood tests and genetic risk factors are assessed to learn more about the genetic risk factors and their effects on the efficacy of the trainings.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005194
  •   2013/12/06
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  •   yes
  •   Approved
  •   12-245, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   healthy older adults, healthy cognitive aging
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Interventions/Observational Groups

  •   The arm NEUROvitalis will be trained with the cognitive training NEUROvitalis. NEUROvitalis is a neuropsychological, cognitive training program for the improvement of the cognitive functions that normally decline during the process of aging. The training course is fully structured. The training consists of twelve sessions. There are two sessions per week, each with a duration of 90 minutes. There is at least one day without session between two sessions. In this study two additional sessions for the repetition of the learned topics are added to ensure that all three arms get the same amount of training time (in sum 14 sessions).
  •   The arm NEUROvitalis Plus physical activity will be trained with the cognitive training of arm 1 and a physical multicomponent group training. NEUROvitalis Plus consists of the same cognitive topics as arm 1, but two additional sessions about “physical activity” and “nutrition” are added as well as a multicomponent training, which is performed for about 20 minutes in every session. Due to this other tasks of the cognitive topic per session are given as homework. The training comprehends 14 sessions. There are two sessions per week, each with a duration of 90 minutes. There is at least one day without session between two sessions.
  •   The arm NEUROvitalis Plus individualized physical activity will be trained with the same cognitive and physical training as arm 2. The training as well comprehends 14 sessions. There are two sessions per week, each with a duration of 90 minutes. There is at least one day without session between two sessions. Additionally the participants of this arm get a single counseling to ensure intensive and individual support in improving their physical activity.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Improvements in cognitive subdomains: attention (Brief test of attention); memory (DemTect, Subtests word list and delayed recall; Complex-Figure-Test); visuo-construction (Complex-Figure-Test); working memory (DemTect, Subtest digit span backwards); word fluency (DemTect, Subtest supermarket/animals; Regensburger Wortflüssigkeits-Test , different subtests); processing speed (Trail Making Test-A; Stroop Test); executive functions (Trail Making Test-B; Stroop Test; BADS, Subtests Key Search, Zoo Map and DEX), and in overall cognitive function (DemTect). The primary outcome will be assessed at times T0 (pretest), T1 (posttest after the intervention), T2 (follow-up after one year), T3 (follow-up after two years).

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Secondary Outcome

Improvements in
1. neurophysiological parameters: assessment of the APO-E- and the BDNF-Genotype, assessment of the level of BDNF, IGF-1, VEGF in the blood.
2. non-cognitive domains: quality of life (WHOQOL-BREF), physical fitness (Senior Fitness Test), motivational questionnaires, questionnaire about nutrition.
All secondary outcomes will be assessed at times T0 (pretest) and T1 (posttest after the intervention). At T2 (follow-up after one year) and T3 (follow-up after two years) alone the cognitive subdomains will be assessed.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2012/10/01
  •   72
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   85   Years
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Additional Inclusion Criteria

cognitive healthy elderly of all educational backgrounds and sufficient verbal skills in German

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Exclusion Criteria

at T0: when participant suffers a neurological or psychiatric disease or alcohol or drug abuse or when vision, hearing or speech is impaired or the achieved score is < 13 in DemTect or > 19 in BDI-II; exclusion of statistical analysis if < 11 sessions (11 sessions match ca. 80% of attendance time) are visited

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Addresses

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    • Universität Vechta, Institut für Gerontologie und Center für Neuropsychologische Diagnostik und Intervention
    • Ms.  Prof. Dr.  Elke  Kalbe 
    • Driverstr. 22
    • 49377  Vechta
    • Germany
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    • Uniklinik Köln, Neurologie, AG Neuropsychologie
    • Mr.  Prof. Dr.  Josef  Kessler 
    • Kerpener Str. 62
    • 50937  Köln
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    • Forschungszentrum Jülich, Institut für Neurowissenschaften und Medizin (INM-3)
    • Mr.  Prof. Dr.  Gereon Rudolf  Fink 
    • Leo-Brandt-Straße
    • 52425  Jülich
    • Germany
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    • Labor Dr. Enzenauer und Kollegen
    • Mr.  PD. Dr. med.  Florian  Szabados 
    • Bramscherstraße 2-4
    • 49088  Osnabrück
    • Germany
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    • St. Franziskus-Hospital Lohne, Fachbereich Geriatrie
    • Mr.  Dr.  Andreas  Rahn 
    • Franziskusstr. 6
    • 49393  Lohne
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Universität Vechta, Institut für Gerontologie und Center für Neuropsychologische Diagnostik und Intervention
    • Ms.  Prof. Dr.  Elke  Kalbe 
    • Driverstr. 22
    • 49377  Vechta
    • Germany
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    • Universität Vechta, Institut für Gerontologie und Center für Neuropsychologische Diagnostik und Intervention
    • Ms.  Julia  Rahe 
    • Driverstr. 22
    • 49377  Vechta
    • Germany
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Sources of Monetary or Material Support

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    • Robert Bosch Stiftung
    • Heidehofstr. 31
    • 70184  Stuttgart
    • Germany
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    • Uniklinik Köln, Neurologie, AG Neuropsychologie
    • Mr.  Prof. Dr.  Josef  Kessler 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    end of 1:1-Block address contact otherSupport
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    • Universität Vechta, Institut für Gerontologie und Center für Neuropsychologische Diagnostik und Intervention
    • Ms.  Prof. Dr.  Elke  Kalbe 
    • Driverstr. 22
    • 49377  Vechta
    • Germany
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    end of 1:1-Block address contact materialSupport
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    • Forschungszentrum Jülich, Institut für Neurowissenschaften und Medizin (INM-3)
    • Mr.  Prof. Dr.  Gereon Rudolf  Fink 
    • Leo-Brandt-Straße
    • 52425  Jülich
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.