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临床试验/NCT02796976
NCT02796976已完成不适用

Exercise, Arterial Cross-Talk Modulation and Inflammation in an Ageing Population (ExAMIN AGE)

University of Basel2 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2016年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
158
试验地点
2
主要终点
Change of pulse wave velocity (m/s)

研究概览

简要总结

The aims of the study are twofold. In the cross-sectional approach (Part I), the study will be conducted in an older population to assess the association of physical fitness on different parts of the human vascular bed. In the interventional approach (Part II), it aims to investigate whether and to what extent advanced vascular ageing (AVA) in older subjects with increased cardiovascular risk can be reversed by regular walking- based high intensity interval training.

详细描述

In the cross-sectional part the investigators analyze physical fitness, vascular health and further outcomes in a healthy older active, a healthy older sedentary and a obese sedentary group with increased cardiovascular risk. The investigators will analyze large and small artery function, physical fitness and activity as well as inflammatory parameters in these three groups. Here the investigators will investigate the influence of physical activity and inflammatory parameters on the vascular health in different beds.

In the intervention part the older sedentary group with increasing cardiovascular risk (OSR) will be randomized in a control and an intervention group. The intervention group will get a high intensity interval training which is walking based and individual adjusted. The control group will get general lifestyle recommendations. After 12 weeks of training OSR group will be tasted again. The aim of the second part is to assess the effect of high intensity interval training on vascular health and inflammatory parameters.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
50 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • men and women aged 50-79 years
  • Active lifestyle: > 9 MET/week (> 3hours moderate walking/week); 18.5≤ BMI ≤ 29.9 kg/m2
  • Sedentary lifestyle: ≤ 3 MET/week (≤ 1 hour moderate walking/week); 18.5≤ BMI ≤ 29.9 kg/m2
  • Sedentary men and women aged 50-79 years with increased cardiovascular risk are allowed to have ≥ one additional cardiovascular risk factor

排除标准

  • History of cardiovascular, pulmonary or chronic inflammatory disease
  • blood pressure ≥ 140/90 mmHg during 24h monitoring
  • current or past smoker (in healthy group)
  • macular degeneration or glaucoma
  • compromising orthopaedic problems

研究组 & 干预措施

healthy older active

No Intervention

only cross-sectional

healthy older sedentary

No Intervention

only cross-sectional

older sedentary at risk

Active Comparator

cross-sectional and training or control condition

干预措施: Training or control condition (Other)

结局指标

主要结局

Change of pulse wave velocity (m/s)

时间窗: Change from baseline pulse wave velocity at 12 weeks

Measured at local, central and peripheral site

次要结局

  • Change of augmentation index (AIx@75) in %(Change from baseline augmentation index at 12 weeks)
  • Change of arteriolar to venular diameter ratio (AVR) in µm(Change from baseline AVR at 12 weeks)
  • Change of physical activity in METs per week(Change from baseline physical activity at 12 weeks)
  • Change of physical fitness in VO2max(Change from baseline VO2max at 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Henner Hanssen

Prof. Dr. med. Henner Hanssen

University of Basel

研究点 (2)

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