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

December 5, 2018 updated by: Henner Hanssen, University of Basel

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Basel Stadt
      • Basel, Basel Stadt, Switzerland, 4052
        • Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin & Systemphysiologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: healthy older active
only cross-sectional
No Intervention: healthy older sedentary
only cross-sectional
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 from baseline pulse wave velocity at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 from baseline augmentation index at 12 weeks
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 from baseline AVR at 12 weeks
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 from baseline physical activity at 12 weeks
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 from baseline VO2max at 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of diastolic function parameters (E/A; E/E')
Time Frame: Change from baseline parameters at 12 weeks
Echocardiography
Change from baseline parameters at 12 weeks
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 from baseline HRV at 12 weeks
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 from baseline serum biomarkers at 12 weeks
Change of cognitive Function
Time Frame: Change from baseline cognitive function at 12 weeks
Executive function test battery
Change from baseline cognitive function at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Basel

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

June 2, 2016

First Submitted That Met QC Criteria

June 10, 2016

First Posted (Estimate)

June 13, 2016

Study Record Updates

Last Update Posted (Actual)

December 6, 2018

Last Update Submitted That Met QC Criteria

December 5, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKNZ-2015-351

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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