Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02796976
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : December 6, 2018
Sponsor:
Collaborators:
University Hospital, Basel, Switzerland
Basel Institute of Clinical Epidemiology (BICE)
Information provided by (Responsible Party):
Henner Hanssen, University of Basel

Tracking Information
First Submitted Date  ICMJE June 2, 2016
First Posted Date  ICMJE June 13, 2016
Last Update Posted Date December 6, 2018
Study Start Date  ICMJE March 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2016)
  • Change of augmentation index (AIx@75) in % [ Time Frame: Change from baseline augmentation index at 12 weeks ]
    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 [ Time Frame: Change from baseline AVR at 12 weeks ]
    Dynamic and static retinal vessel analyzes will be investigated
  • Change of physical activity in METs per week [ Time Frame: Change from baseline physical activity at 12 weeks ]
    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 [ Time Frame: Change from baseline VO2max at 12 weeks ]
    An individual treadmill ramp test will be used to investigate peak oxygen consumption and maximal heart rate.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 10, 2016)
  • Change of diastolic function parameters (E/A; E/E`) [ Time Frame: Change from baseline parameters at 12 weeks ]
    Echocardiography
  • Change of autonomic function in heart rate variability (HRV) in beats per minute (bpm) [ Time Frame: Change from baseline HRV at 12 weeks ]
    12-lead ECG monitoring
  • Change of serum biomarkers (hs-CRP, IL-6, IL-10, TNF-α) [ Time Frame: Change from baseline serum biomarkers at 12 weeks ]
    Blood sampling
  • Change of cognitive Function [ Time Frame: Change from baseline cognitive function at 12 weeks ]
    Executive function test battery
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Exercise, Arterial Cross-Talk Modulation and Inflammation in an Ageing Population
Official Title  ICMJE Exercise, Arterial Cross-Talk Modulation and Inflammation in an Ageing Population (ExAMIN AGE)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Disease
  • Obesity
  • Atherosclerosis
  • Heart; Disease, Activity
Intervention  ICMJE 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.
Study Arms  ICMJE
  • No Intervention: healthy older active
    only cross-sectional
  • No Intervention: healthy older sedentary
    only cross-sectional
  • Active Comparator: older sedentary at risk
    cross-sectional and training or control condition
    Intervention: Other: Training or control condition
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2018)
158
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2016)
180
Actual Study Completion Date  ICMJE February 2018
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02796976
Other Study ID Numbers  ICMJE EKNZ-2015-351
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Henner Hanssen, University of Basel
Study Sponsor  ICMJE University of Basel
Collaborators  ICMJE
  • University Hospital, Basel, Switzerland
  • Basel Institute of Clinical Epidemiology (BICE)
Investigators  ICMJE Not Provided
PRS Account University of Basel
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP