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Completed

NCT Number: NCT02796976

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

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.

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Key information

Conditions

Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Behavior Body Weight Cardiovascular Diseases Disease Heart; Disease, Activity Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

50 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin & Systemphysiologie

Basel, Canton of Basel-City, 4052, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training or control condition

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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®)

  2. 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

  3. 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.

  4. 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.

Other outcomes

  1. Change of diastolic function parameters (E/A; E/E')

    Time frame: Change from baseline parameters at 12 weeks

    Echocardiography

  2. 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

  3. Change of serum biomarkers (hs-CRP, IL-6, IL-10, TNF-α)

    Time frame: Change from baseline serum biomarkers at 12 weeks

    Blood sampling

  4. Change of cognitive Function

    Time frame: Change from baseline cognitive function at 12 weeks

    Executive function test battery

Sponsors and collaborators

Lead sponsor

University of Basel

Other

Collaborators

  • Basel Institute of Clinical Epidemiology (BICE)
  • University Hospital, Basel, Switzerland

Registry information

Official study title

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

Acronym: ExAMIN AGE

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jun 13, 2016
Registry last updated
Dec 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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