G30 F00
Conditions
Interventions
Group 1: Intervention
-Motor activity anamnesis
-1-3 times a week combined physical and cognitive activity programme
-1-2 times a month telephone counselling (month3-6)
Group 2: Control intervention -
Sponsors
Universitätsklinikum Essen
Universität Duisburg-Essen
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Contacts
Public ContactBernhard Müller
Rheinische Kliniken Essen Klinik für Psychiatrie und Psychotherapie Universität Duisburg-Essen
Outcome results
None listed