NCT02796976

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

December 6, 2018

Status Verified

December 1, 2018

Enrollment Period

1.8 years

First QC Date

June 2, 2016

Last Update Submit

December 5, 2018

Conditions

Cardiovascular DiseaseObesityAtherosclerosisHeart; Disease, Activity

Keywords

arterial stiffnessretinal vesselsphysical activityageing

Outcome Measures

Primary Outcomes (1)

  • Change of pulse wave velocity (m/s)

    Measured at local, central and peripheral site

    Change from baseline pulse wave velocity at 12 weeks

Secondary Outcomes (4)

  • 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

Other Outcomes (4)

  • Change of diastolic function parameters (E/A; E/E')

    Change from baseline parameters at 12 weeks

  • Change of autonomic function in heart rate variability (HRV) in beats per minute (bpm)

    Change from baseline HRV at 12 weeks

  • Change of serum biomarkers (hs-CRP, IL-6, IL-10, TNF-α)

    Change from baseline serum biomarkers at 12 weeks

  • +1 more other outcomes

Study Arms (3)

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

Other: Training or control condition

Interventions

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.

older sedentary at risk

Eligibility Criteria

Age50 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin & Systemphysiologie

Basel, Canton of Basel-City, 4052, Switzerland

Location

Related Publications (7)

  • 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.

    PMID: 25558034BACKGROUND

  • 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.

    PMID: 24728623BACKGROUND

  • 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.

    PMID: 21392768BACKGROUND

  • 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.

    PMID: 35194110DERIVED

  • 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.

    PMID: 31551805DERIVED

  • 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.

    PMID: 31333489DERIVED

  • 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.

    PMID: 31323685DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesObesityAtherosclerosisDiseaseMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Henner Hanssen

Study Record Dates

First Submitted

June 2, 2016

First Posted

June 13, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2017

Study Completion

February 1, 2018

Last Updated

December 6, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)