NL-OMON54045已完成不适用
The effects of a multidomain lifestyle intervention on brain functioning and its relation with immunometabolic markers in ageing - HELI
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Age between 60-75 years (at pre-screening)
- •- Fluency in Dutch (speaking, reading and writing)
- •- Lives near study centres in Nijmegen and Wageningen (maximum of 50km of
- •traveling to either Nijmegen or Wageningen)
- •- Score >=2 points on the 6 modifiable cardiovascular risk factors listed below:
- •1. BMI >=25 (1 point)
- •2. Physical inactivity (below the 2020 WHO guidelines, meaning: <300 min of
- •moderate intensity aerobic physical activity, or <150 min of vigorous intensity
- •aerobic physical activity per week, spread out over several days) (1 point)
- •3. Hypertension (1 point, 2 points if hypertension is untreated)
- •4. Hypercholesterolemia (1 point)
- •5. Diabetes type-II (1 point)
- •6. Cardiovascular disease (EXCEPT: symptomatic cardiovascular disease such as
- •stroke, angina pectoris, heart failure, myocardial infarction, OR
- •revascularisation surgery in the last 12 months at pre-screening) (1 point)
排除标准
- •- Concurrent participation in other intervention trials
- •- Technologically illiterate (complete incompetence in working with computers,
- •apps, online questionnaires, etc.)
- •- No internet access from home
- •- Clinical diagnosis of >=1 of the following:
- •> Vascular event (CVA);
- •> Neurological pathology (e.g. MCI, dementia, MS, Parkinson's, epilepsy);
- •> Current malignant disease(s), with or without treatment;
- •> Current psychiatric disorder(s) (e.g. depression, psychosis, bipolar
- •> Symptomatic cardiovascular disease (e.g. stroke, angina pectoris, heart
- •failure, myocardial infarction);
- •> Revascularisation surgery in the last 12 months at pre-screening;
- •> Inflammatory bowel disease (characterised with diarrhoea);
- •> Visual impairment (e.g. blindness);
- •> Hearing or communicative impairment.
- •- Answering Yes on >=1 of the Donders Institute MRI safety screening protocol
- •questions (see 8 questions below):
- •1. Are there metal objects located in your upper body? Exception:
- •tooth-fillings and/or dental crowns.
- •2. Are there metal splinters in your body, in particular within the eyes? For
- •example: through labour work in the metal industry.
- •3. Are there jewellery items or piercings that you are unable to take off?
- •4. Have you had a brain surgery in the past?
- •5. Are there active implants present? For example: pacemaker, neurostimulator,
- •insulinpump, hearing aid (that is unable to be removed).
- •6. Are there any medical plasters or patches that you can*t or may not take
- •off? For example: nicotine patch.
- •7. Do you suffer from epilepsy?
- •8. Do you suffer from claustrophobia?
- •- Cognitive impairment as determined by Telephone Interview for Cognitive
- •Status (TICS-M1), performed during pre-screening before inclusion.
研究者
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