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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02796976
Acronym
ExAMIN AGE
Enrollment
158
Registered
2016-06-13
Start date
2016-03-31
Completion date
2018-02-28
Last updated
2018-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

arterial stiffness, retinal vessels, physical activity, ageing

Brief summary

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

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.

Interventions

OTHERTraining 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.

Sponsors

University Hospital, Basel, Switzerland
CollaboratorOTHER
Basel Institute of Clinical Epidemiology (BICE)
CollaboratorOTHER
University of Basel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to 79 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change of pulse wave velocity (m/s)Change from baseline pulse wave velocity at 12 weeksMeasured at local, central and peripheral site

Secondary

MeasureTime frameDescription
Change of augmentation index (AIx@75) in %Change from baseline augmentation index at 12 weeksAIx 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 µmChange from baseline AVR at 12 weeksDynamic and static retinal vessel analyzes will be investigated
Change of physical activity in METs per weekChange from baseline physical activity at 12 weeksThe 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 VO2maxChange from baseline VO2max at 12 weeksAn individual treadmill ramp test will be used to investigate peak oxygen consumption and maximal heart rate.

Other

MeasureTime frameDescription
Change of autonomic function in heart rate variability (HRV) in beats per minute (bpm)Change from baseline HRV at 12 weeks12-lead ECG monitoring
Change of serum biomarkers (hs-CRP, IL-6, IL-10, TNF-α)Change from baseline serum biomarkers at 12 weeksBlood sampling
Change of cognitive FunctionChange from baseline cognitive function at 12 weeksExecutive function test battery
Change of diastolic function parameters (E/A; E/E')Change from baseline parameters at 12 weeksEchocardiography

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026