Clinical trial NCT02796976: Exercise, Arterial Cross-Talk Modulation and Inflammation in an Ageing Population
Official title: Exercise, Arterial Cross-Talk Modulation and Inflammation in an Ageing Population (ExAMIN AGE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Obesity
Atherosclerosis
Heart; Disease, Activity
Keywords: arterial stiffness
retinal vessels
physical activity
ageing
Lead sponsor: University of Basel
Sponsor class: OTHER
Collaborators: name: University Hospital, Basel, Switzerland
name: Basel Institute of Clinical Epidemiology (BICE)
First posted: 2016-06-13
Enrollment: 158
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change of pulse wave velocity (m/s)
timeFrame: Change from baseline pulse wave velocity at 12 weeks
Secondary outcomes:
measure: Change of augmentation index (AIx@75) in %
timeFrame: Change from baseline augmentation index at 12 weeks
measure: Change of arteriolar to venular diameter ratio (AVR) in µm
timeFrame: Change from baseline AVR at 12 weeks
measure: Change of physical activity in METs per week
timeFrame: Change from baseline physical activity at 12 weeks
measure: Change of physical fitness in VO2max
timeFrame: Change from baseline VO2max at 12 weeks
Other outcomes:
measure: Change of diastolic function parameters (E/A; E/E')
timeFrame: Change from baseline parameters at 12 weeks
measure: Change of autonomic function in heart rate variability (HRV) in beats per minute (bpm)
timeFrame: Change from baseline HRV at 12 weeks
measure: Change of serum biomarkers (hs-CRP, IL-6, IL-10, TNF-α)
timeFrame: Change from baseline serum biomarkers at 12 weeks
measure: Change of cognitive Function
timeFrame: Change from baseline cognitive function at 12 weeks
Locations:
city: Basel
country: Switzerland
facility: Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin & Systemphysiologie
state: Basel Stadt
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.