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

Primary Purpose

Cardiovascular Disease, Obesity, Atherosclerosis

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Training or control condition
Sponsored by
University of Basel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Disease focused on measuring arterial stiffness, retinal vessels, physical activity, ageing

Eligibility Criteria

50 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin & Systemphysiologie

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Active Comparator

Arm Label

healthy older active

healthy older sedentary

older sedentary at risk

Arm Description

only cross-sectional

only cross-sectional

cross-sectional and training or control condition

Outcomes

Primary Outcome Measures

Change of pulse wave velocity (m/s)
Measured at local, central and peripheral site

Secondary Outcome Measures

Change of augmentation index (AIx@75) in %
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
Dynamic and static retinal vessel analyzes will be investigated
Change of physical activity in METs per week
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
An individual treadmill ramp test will be used to investigate peak oxygen consumption and maximal heart rate.

Full Information

First Posted
June 2, 2016
Last Updated
December 5, 2018
Sponsor
University of Basel
Collaborators
University Hospital, Basel, Switzerland, Basel Institute of Clinical Epidemiology (BICE)
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1. Study Identification

Unique Protocol Identification Number
NCT02796976
Brief Title
Exercise, Arterial Cross-Talk Modulation and Inflammation in an Ageing Population
Acronym
ExAMIN AGE
Official Title
Exercise, Arterial Cross-Talk Modulation and Inflammation in an Ageing Population (ExAMIN AGE)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Basel
Collaborators
University Hospital, Basel, Switzerland, Basel Institute of Clinical Epidemiology (BICE)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Obesity, Atherosclerosis, Heart; Disease, Activity
Keywords
arterial stiffness, retinal vessels, physical activity, ageing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
healthy older active
Arm Type
No Intervention
Arm Description
only cross-sectional
Arm Title
healthy older sedentary
Arm Type
No Intervention
Arm Description
only cross-sectional
Arm Title
older sedentary at risk
Arm Type
Active Comparator
Arm Description
cross-sectional and training or control condition
Intervention Type
Other
Intervention Name(s)
Training or control condition
Intervention Description
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 Outcome Measure Information:
Title
Change of pulse wave velocity (m/s)
Description
Measured at local, central and peripheral site
Time Frame
Change from baseline pulse wave velocity at 12 weeks
Secondary Outcome Measure Information:
Title
Change of augmentation index (AIx@75) in %
Description
AIx and AIx@75 will be measured by using the gold standard device for single measurements (SphygmoCor®)
Time Frame
Change from baseline augmentation index at 12 weeks
Title
Change of arteriolar to venular diameter ratio (AVR) in µm
Description
Dynamic and static retinal vessel analyzes will be investigated
Time Frame
Change from baseline AVR at 12 weeks
Title
Change of physical activity in METs per week
Description
The Freiburger Questionnaire of physical activity and inactivity and an accelerometer for seven days will be used to measure physical activity.
Time Frame
Change from baseline physical activity at 12 weeks
Title
Change of physical fitness in VO2max
Description
An individual treadmill ramp test will be used to investigate peak oxygen consumption and maximal heart rate.
Time Frame
Change from baseline VO2max at 12 weeks
Other Pre-specified Outcome Measures:
Title
Change of diastolic function parameters (E/A; E/E')
Description
Echocardiography
Time Frame
Change from baseline parameters at 12 weeks
Title
Change of autonomic function in heart rate variability (HRV) in beats per minute (bpm)
Description
12-lead ECG monitoring
Time Frame
Change from baseline HRV at 12 weeks
Title
Change of serum biomarkers (hs-CRP, IL-6, IL-10, TNF-α)
Description
Blood sampling
Time Frame
Change from baseline serum biomarkers at 12 weeks
Title
Change of cognitive Function
Description
Executive function test battery
Time Frame
Change from baseline cognitive function at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin & Systemphysiologie
City
Basel
State/Province
Basel Stadt
ZIP/Postal Code
4052
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25558034
Citation
Hanssen H, Nussbaumer M, Moor C, Cordes M, Schindler C, Schmidt-Trucksass A. Acute effects of interval versus continuous endurance training on pulse wave reflection in healthy young men. Atherosclerosis. 2015 Feb;238(2):399-406. doi: 10.1016/j.atherosclerosis.2014.12.038. Epub 2014 Dec 23.
Results Reference
background
PubMed Identifier
24728623
Citation
Nussbaumer M, Donath L, Fischer M, Schafer J, Faude O, Zahner L, Schmidt-Trucksass A, Hanssen H. Effects of acute bouts of endurance exercise on retinal vessel diameters are age and intensity dependent. Age (Dordr). 2014 Jun;36(3):9650. doi: 10.1007/s11357-014-9650-3. Epub 2014 Apr 12.
Results Reference
background
PubMed Identifier
21392768
Citation
Hanssen H, Nickel T, Drexel V, Hertel G, Emslander I, Sisic Z, Lorang D, Schuster T, Kotliar KE, Pressler A, Schmidt-Trucksass A, Weis M, Halle M. Exercise-induced alterations of retinal vessel diameters and cardiovascular risk reduction in obesity. Atherosclerosis. 2011 Jun;216(2):433-9. doi: 10.1016/j.atherosclerosis.2011.02.009. Epub 2011 Feb 17.
Results Reference
background
PubMed Identifier
35194110
Citation
Streese L, Demougin P, Iborra P, Kanitz A, Deiseroth A, Kropfl JM, Schmidt-Trucksass A, Zavolan M, Hanssen H. Untargeted sequencing of circulating microRNAs in a healthy and diseased older population. Sci Rep. 2022 Feb 22;12(1):2991. doi: 10.1038/s41598-022-06956-4.
Results Reference
derived
PubMed Identifier
31551805
Citation
Deiseroth A, Streese L, Kochli S, Wust RS, Infanger D, Schmidt-Trucksass A, Hanssen H. Exercise and Arterial Stiffness in the Elderly: A Combined Cross-Sectional and Randomized Controlled Trial (EXAMIN AGE). Front Physiol. 2019 Sep 4;10:1119. doi: 10.3389/fphys.2019.01119. eCollection 2019.
Results Reference
derived
PubMed Identifier
31333489
Citation
Streese L, Kotliar K, Deiseroth A, Infanger D, Vilser W, Hanssen H. Retinal Endothelial Function, Physical Fitness and Cardiovascular Risk: A Diagnostic Challenge. Front Physiol. 2019 Jul 5;10:831. doi: 10.3389/fphys.2019.00831. eCollection 2019.
Results Reference
derived
PubMed Identifier
31323685
Citation
Streese L, Khan AW, Deiseroth A, Hussain S, Suades R, Tiaden A, Kyburz D, Cosentino F, Hanssen H. High-intensity interval training modulates retinal microvascular phenotype and DNA methylation of p66Shc gene: a randomized controlled trial (EXAMIN AGE). Eur Heart J. 2020 Apr 14;41(15):1514-1519. doi: 10.1093/eurheartj/ehz196.
Results Reference
derived

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

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