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

Obesity Clinical Trial

— ExAMIN AGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796976
• Other study ID #: EKNZ-2015-351
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: February 2018

Study information

• Verified date: December 2018
• Source: University of Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Disease
• Cardiovascular Diseases
• Heart; Disease, Activity
• Inflammation
• Obesity

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin & Systemphysiologie	Basel	Basel Stadt

Sponsors (3)

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

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

Hanssen H, Nickel T, Drexel V, Hertel G, Emslander I, Sisic Z, Lorang D, Schuster T, Kotliar KE, Pressler A, Schmidt-Trucksäss 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. — View Citation

Hanssen H, Nussbaumer M, Moor C, Cordes M, Schindler C, Schmidt-Trucksäss 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. — View Citation

Nussbaumer M, Donath L, Fischer M, Schäfer J, Faude O, Zahner L, Schmidt-Trucksäss 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of diastolic function parameters (E/A; E/E`)	Echocardiography	Change from baseline parameters at 12 weeks
Other	Change of autonomic function in heart rate variability (HRV) in beats per minute (bpm)	12-lead ECG monitoring	Change from baseline HRV at 12 weeks
Other	Change of serum biomarkers (hs-CRP, IL-6, IL-10, TNF-a)	Blood sampling	Change from baseline serum biomarkers at 12 weeks
Other	Change of cognitive Function	Executive function test battery	Change from baseline cognitive function at 12 weeks
Primary	Change of pulse wave velocity (m/s)	Measured at local, central and peripheral site	Change from baseline pulse wave velocity at 12 weeks
Secondary	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 from baseline augmentation index at 12 weeks
Secondary	Change of arteriolar to venular diameter ratio (AVR) in µm	Dynamic and static retinal vessel analyzes will be investigated	Change from baseline AVR at 12 weeks
Secondary	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 from baseline physical activity at 12 weeks
Secondary	Change of physical fitness in VO2max	An individual treadmill ramp test will be used to investigate peak oxygen consumption and maximal heart rate.	Change from baseline VO2max at 12 weeks