Cardiovascular DiseaseExAMIN AGENCT02796976

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

A study of Cardiovascular Disease and Obesity, run by University of Basel at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 to 79 yearsHealthy volunteers can take part
Conditions the study is for: Cardiovascular Disease, Obesity, Atherosclerosis
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 158 participants
Where: 1 siteSwitzerland
Study dates: Mar 2016to Feb 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 79 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin & Systemphysiologie
Basel, Canton of Basel-City, 4052

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

Conditions: Cardiovascular Disease, Obesity, Atherosclerosis, Heart; Disease, Activity
Being tested: Training or control condition
Keywords: arterial stiffness, retinal vessels, physical activity, ageing
Medical subject headings: Cardiovascular Diseases, Obesity, Atherosclerosis, Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Training or control conditionOther
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.

Study groups in NCT02796976
Study group	Role	What they receive
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 Receives: Other: Training or control condition

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of pulse wave velocity (m/s)
Measured at local, central and peripheral site
Measured: Change from baseline pulse wave velocity at 12 weeks

Secondary outcomes (4)

Change of augmentation index (AIx@75) in %
AIx and AIx@75 will be measured by using the gold standard device for single measurements (SphygmoCor®)
Measured: Change from baseline augmentation index at 12 weeks
Change of arteriolar to venular diameter ratio (AVR) in µm
Dynamic and static retinal vessel analyzes will be investigated
Measured: Change from baseline AVR at 12 weeks
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.
Measured: Change from baseline physical activity at 12 weeks
Change of physical fitness in VO2max
An individual treadmill ramp test will be used to investigate peak oxygen consumption and maximal heart rate.
Measured: Change from baseline VO2max at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Feb 2018

First posted13 Jun 2016 (estimated)
Study startMar 2016
Primary completionDec 2017
Study completionFeb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 158 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02796976
Sponsor's protocol ID: EKNZ-2015-351
Acronym: ExAMIN AGE
Status last verified: Dec 2018
First submitted: 2 Jun 2016
Last updated: 6 Dec 2018
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 25558034
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.
PubMed 24728623
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.
PubMed 21392768
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.
PubMed 35194110
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.
PubMed 31551805
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.
PubMed 31333489
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.
PubMed 31323685

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exercise, Arterial Cross-Talk Modulation and Inflammation in an Ageing Population (ExAMIN AGE)
ClinicalTrials.gov ID: NCT02796976
Acronym / sponsor ID: ExAMIN AGE / EKNZ-2015-351
Conditions: Cardiovascular Disease, Obesity, Atherosclerosis, Heart; Disease, Activity
Keywords: arterial stiffness, retinal vessels, physical activity, ageing
Study type: Interventional
Recruitment status: Completed
Enrolment: 158 participants (actual)
Lead sponsor: University of BaselUniversity, hospital or other
Collaborators: University Hospital, Basel, Switzerland, Basel Institute of Clinical Epidemiology (BICE)
Study start: Mar 2016
Primary completion: Dec 2017 (actual)
Study completion: Feb 2018 (actual)
First posted: 13 Jun 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
healthy older active	No intervention	–only cross-sectional
healthy older sedentary	No intervention	–only cross-sectional
older sedentary at risk	Active comparator	Other: Training or control conditioncross-sectional and training or control condition

Who may qualify

Ages: 50 to 79 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Training or control conditionParticipants 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.	Other	older sedentary at risk

Primary outcome

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

4 secondary outcomes

Change of augmentation index (AIx@75) in %
Time frame: 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
Change of physical activity in METs per week
Time frame: Change from baseline physical activity at 12 weeks
Change of physical fitness in VO2max
Time frame: Change from baseline VO2max at 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
Background: PubMed 25558034Hanssen 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.
Background: PubMed 24728623Nussbaumer 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.
Background: PubMed 21392768Hanssen 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.
Derived from this study: PubMed 35194110Streese 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.
Derived from this study: PubMed 31551805Deiseroth 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.
Derived from this study: PubMed 31333489Streese 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.
Derived from this study: PubMed 31323685Streese 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Cardiovascular Disease and Obesity, run by University of Basel at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of pulse wave velocity (m/s) (time frame: Change from baseline pulse wave velocity at 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02796976, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2018.