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
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