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临床试验/DRKS00000100
DRKS00000100尚未招募未知

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

niversitätsklinikum EssenUniversität Duisburg-Essen0 个研究点目标入组 300 人开始时间: 2009年3月24日最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
发起方
入组人数
300

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
50 Years 至 one(—)
性别
All

入选标准

  • 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

排除标准

  • -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

研究者

发起方
niversitätsklinikum EssenUniversität Duisburg-Essen

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