Trial document




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  DRKS00000100

Trial Description

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Title

The influence of multimodal physical activity on cognition and everyday life competence in patients with early Alzheimer's disease

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Trial Acronym

Sport & KOG

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URL of the Trial

http://www.uni-due.de/rke-ap/SportUndCog.shtml

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Brief Summary in Lay Language

There is evidence that physical activity and cognitive activation retards the development of Alzheimer's disease. Only few trails have already examined the influence of a combined physical and cognitive activity on cognitive function in patients with early Alzheimer's disease.

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Brief Summary in Scientific Language

The aim of the trail is to analyse if multimodal physical activity significantly improves cognitive function and everyday life competence of patients with early Alzheimer's disease. Primary endpoints are the measurement of cognitive reduction with ADAS-Cog. Activities of daily living are measured using the ADCS-ADL.

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Organizational Data

  •   DRKS00000100
  •   2009/03/24
  •   [---]*
  •   yes
  •   Approved
  •   08-3818, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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

  •   G30 -  Alzheimer's disease
  •   F00 -  Dementia in Alzheimer's disease
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Interventions/Observational Groups

  •   Intervention
    -Motor activity anamnesis
    -1-3 times a week combined physical and cognitive activity programme
    -1-2 times a month telephone counselling (month3-6)
  •   Control intervention - Stretching
    -Motor activity anamnesis
    -1-3 times a week stretching programme
    -1-2 times a month telephone counselling (month3-6)
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Characteristics

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

Primary endpoints are measured at T0 (after screening), T1 (month 6) and T2 (month 12)
-measurement of cognitive reduction with ADAS-Cog
-Activities of daily living are measured using the ADCS-ADL

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Secondary Outcome

Secondary endpoints are measured at T0 (after screening), T1 (month 6) and T2 (month 12)
-MWT-B (Mehrfachwahl-Wortschatztest)
-SKT (Syndrom-Kurz-Test)
-Clinical Dementia Rating (CDR)
-DEMQOL (Smith, et al., 2005)
-SF12 (Quality of life)
-HPS (Häusliche Pflegeskala)
-NPI (Neuropsychiatric Inventory)
-BDI (Beck Depression Inventory)
-PASE (physical activity)
-GPAQ (physical activity)
-measurement of physical activity by pedometer

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Planned
  •   2009/04/01
  •   300
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   no maximum age
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Additional Inclusion Criteria

-diagnosis of Alzheimer's dementia according to NINCDS-ADRDA respectively ICD 10
-Mini-Mental-State-Test (20 - 25) at screening
-Hachinski Ischemia Scale <=4 at screening
-CT or MRT, maximal 2 years old, compatible with Alzheimer's dementia
-Geriatric Depression Scale (GDS) <=4 (15-item scale)
-ambulant patients
-exercise ECG analysed by specialist in internal medicine
-caregiver (contact 3 times a week, overall 5 hours a week), who can report the patient's state of health
-informed consent form signed by patient and caregiver

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Exclusion Criteria

-diagnosis of a possible, probable or certain vascular dementia NINDS-AIREN criteria
-missing approval ability, missing ability to take part in intervention programme or missing compliance
-intake of following drugs with change of dosage during the last 3 months before baseline: antidepressants, tranquilizer / sleeping pills, anti-psychotica or anti-epileptica
-excessive alcohol, drug or medicament abuse. Diagnosis of drug abuse or drug addiction (ICD-10) as a primary clinical diagnosis, which indicates the initiation or continuation of a medical treatment of this disorder
-clinically relevant neurologic or psychiatric diseases, such as severe depression, schizophrenia, epilepsy or Parkinson's disease
-participation in a pharmaceutical trail 2 months before baseline
-decompensated or poorly regulated diabetes
-decompensated or poorly regulated hypertonia
-cardiovascular event during the last 3 months e.g. cardiac catheterization, vascular surgery, acute coronary syndrome, myocardial infarction or unstable angina, clinical relevant cardiac dysrhythmia, cardiac surgery, angiography with stent implantation
-other clinically significant aberrances in clinical, neurologic, laboratory medicine examination, clinically relevant ECG changes, which could impair the patient's health related to the trail
-cardiologically relevant anaemia

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Addresses

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    • Universitätsklinikum Essen Universität Duisburg-Essen
    • Hufelandandstrasse 55
    • 45147  Essen
    • Germany
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    • Rheinische Kliniken Essen Klinik für Psychiatrie und Psychotherapie Universität Duisburg-Essen
    • Mr.  Prof. Dr. med.  Jens  Wiltfang 
    • Virchowstr. 174
    • 45147  Essen
    • Germany
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    • Rheinische Kliniken Essen Klinik für Psychiatrie und Psychotherapie Universität Duisburg-Essen
    • Mr.  Dr.  Bernhard  Müller 
    • Virchowstr. 174
    • 45147  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Deutsches Zentrum für Luft- und Raumfahrt e.V. Projektträger im DLR Gesundheitsforschung für das Bundesministerium für Gesundheit
    • Heinrich-Konen-Straße 1
    • 53227  Bonn
    • Germany
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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.