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

Not Applicable

• Conditions: G30; F00; Alzheimer disease; Dementia in Alzheimer disease

• Registration Number: DRKS00000100
• Lead Sponsor: niversitätsklinikum EssenUniversität Duisburg-Essen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 300

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

-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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoints are measured at T0 (after screening), T1 (month 6) and T2 (month 12)<br>-measurement of cognitive reduction with ADAS-Cog<br>-Activities of daily living are measured using the ADCS-AD

Secondary Outcome Measures

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