Trial document




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  DRKS00017745

Trial Description

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Title

TEAMSenior in practice

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Trial Acronym

TEAMSenior

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URL of the Trial

http://www.iknd.ovgu.de/Team/Ärtze+_+Wissenschaftliche+Mitarbeiter+der+AG+Düzel/Autonomie+im+Alter.html

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Brief Summary in Lay Language

People with mild Alzheimer's dementia train 24 weeks on a special bicycle ergometer, which offers a combination of memory- and endurance training. The subjects are accompanied by volunteer seniors. The aim is to improve the autonomy of people with dementia and reduce the relatives burden with the help of volunteer seniors.

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Brief Summary in Scientific Language

The aim is to provide the intervention "team senior in practice" for a high risk of rapid cognitive decline as beginning and mild Alzheimer's disease with a deficiency of exercise as a metabolic risk factor. The system should be easy to use for people with neurodegenerative diseases and allow monitoring of physical and mental functions.

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Organizational Data

  •   DRKS00017745
  •   2019/09/03
  •   [---]*
  •   yes
  •   Approved
  •   102/19, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   G30 -  Alzheimer disease
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Interventions/Observational Groups

  •   Intervention group 1
    Control group without intervention
  •   Intervention Group 2
    Subject trains on the ergometer without TEAM partner
  •   Intervention group 3
    subject trains on the ergometer and gets a TEAM partner
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Mini-Mental Status-Test, ADAS-Cog, Geriatric Depression Scale

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Secondary Outcome

B-ADL, QOL-AD, fitness, neural correlates

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2020/01/01
  •   90
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   60   Years
  •   80   Years
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Additional Inclusion Criteria

Age: 60 to 80
Suspected or diagnosed mild cognitive impairment (MCI) or mild Alzheimer's dementia
Physical inactivity according to WHO recommendations: <150 minutes of moderate physical activity per week

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Exclusion Criteria

Contraindications to a long-term ergometer training (severe cardiovascular disease, severe insulin-dependent diabetes, arterial disease, severe hypertension, severe medical illness)

current major depressive disorder and / or severe neuropsychological disorder

current severe neurological disease of the central nervous system

current dependence (e.g., alcohol, psychological pharmaceuticals, cocaine, heroin)

taking benzodiazepines

Severe visual and hearing impairments (uncorrected)

Subjects who are not evaluated as suitable for sports in the context of the primary care check-up

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Addresses

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    • Universitätsklinikum Magdeburg
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Institut für Kognitive Neurologie und Demenzforschung
    • Mr.  Professor  Emrah  Düzel 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Institut für Kognitive Neurologie und Demenzforschung
    • Ms.  M.Sc.  Nancy  Busse 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Investitionsbank Sachsen-Anhalt
    • 39104  Magdeburg
    • Germany
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    •   [---]*
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Status

  •   Recruiting planned
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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.