Exercise, Arterial Cross-Talk Modulation and Inflammation in an Ageing Population

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cardiovascular Disease, Obesity, Atherosclerosis, Heart; Disease, Activity

Intervention / Treatment
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* Other: Training or control condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: healthy older active<br>only cross-sectional | |
| No Intervention: healthy older sedentary<br>only cross-sectional | |
| Active Comparator: older sedentary at risk<br>cross-sectional and training or control condition | Other: Training or control condition<br>* Participants get a 12 week high intensity and walking-based interval training which is adapted to their individual physical fitness level or a general recommendation on physical activity according to European Guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pulse wave velocity (m/s) | Measured at local, central and peripheral site | Change from baseline pulse wave velocity at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of augmentation index (AIx@75) in % | AIx and AIx@75 will be measured by using the gold standard device for single measurements (SphygmoCor®) | Change from baseline augmentation index at 12 weeks | 
| Change of arteriolar to venular diameter ratio (AVR) in µm | Dynamic and static retinal vessel analyzes will be investigated | Change from baseline AVR at 12 weeks | 
| Change of physical activity in METs per week | The Freiburger Questionnaire of physical activity and inactivity and an accelerometer for seven days will be used to measure physical activity. | Change from baseline physical activity at 12 weeks | 
| Change of physical fitness in VO2max | An individual treadmill ramp test will be used to investigate peak oxygen consumption and maximal heart rate. | Change from baseline VO2max at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arterial stiffness, retinal vessels, physical activity, ageing