Exercise, Arterial Cross-Talk Modulation and Inflammation in an Ageing Population (ExAMIN AGE)
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|ClinicalTrials.gov Identifier: NCT02796976|
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : December 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease Obesity Atherosclerosis Heart; Disease, Activity||Other: Training or control condition||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||158 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Exercise, Arterial Cross-Talk Modulation and Inflammation in an Ageing Population (ExAMIN AGE)|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||February 2018|
No Intervention: healthy older active
No Intervention: healthy older sedentary
Active Comparator: older sedentary at risk
cross-sectional and training or control condition
Other: Training or control condition
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.
- Change of pulse wave velocity (m/s) [ Time Frame: Change from baseline pulse wave velocity at 12 weeks ]Measured at local, central and peripheral site
- Change of augmentation index (AIx@75) in % [ Time Frame: Change from baseline augmentation index at 12 weeks ]AIx and AIx@75 will be measured by using the gold standard device for single measurements (SphygmoCor®)
- Change of arteriolar to venular diameter ratio (AVR) in µm [ Time Frame: Change from baseline AVR at 12 weeks ]Dynamic and static retinal vessel analyzes will be investigated
- Change of physical activity in METs per week [ Time Frame: Change from baseline physical activity at 12 weeks ]The Freiburger Questionnaire of physical activity and inactivity and an accelerometer for seven days will be used to measure physical activity.
- Change of physical fitness in VO2max [ Time Frame: Change from baseline VO2max at 12 weeks ]An individual treadmill ramp test will be used to investigate peak oxygen consumption and maximal heart rate.
- Change of diastolic function parameters (E/A; E/E') [ Time Frame: Change from baseline parameters at 12 weeks ]Echocardiography
- Change of autonomic function in heart rate variability (HRV) in beats per minute (bpm) [ Time Frame: Change from baseline HRV at 12 weeks ]12-lead ECG monitoring
- Change of serum biomarkers (hs-CRP, IL-6, IL-10, TNF-α) [ Time Frame: Change from baseline serum biomarkers at 12 weeks ]Blood sampling
- Change of cognitive Function [ Time Frame: Change from baseline cognitive function at 12 weeks ]Executive function test battery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796976
|Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin & Systemphysiologie|
|Basel, Basel Stadt, Switzerland, 4052|