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Clinical Trials/NCT02796976
NCT02796976CompletedNot Applicable

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

University of Basel1 site in 1 country158 target enrollmentStarted: March 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
158
Locations
1
Primary Endpoint
Change of pulse wave velocity (m/s)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
50 Years to 79 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

healthy older active

No Intervention

only cross-sectional

healthy older sedentary

No Intervention

only cross-sectional

older sedentary at risk

Active Comparator

cross-sectional and training or control condition

Intervention: Training or control condition (Other)

Outcomes

Primary Outcomes

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

  • Change of augmentation index (AIx@75) in %(Change from baseline augmentation index at 12 weeks)
  • Change of arteriolar to venular diameter ratio (AVR) in µm(Change from baseline AVR at 12 weeks)
  • Change of physical activity in METs per week(Change from baseline physical activity at 12 weeks)
  • Change of physical fitness in VO2max(Change from baseline VO2max at 12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Henner Hanssen

Prof. Dr. med. Henner Hanssen

University of Basel

Study Sites (1)

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