Working...
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

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Obesity Atherosclerosis Heart; Disease, Activity Other: Training or control condition Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Exercise, Arterial Cross-Talk Modulation and Inflammation in an Ageing Population (ExAMIN AGE)
Study Start Date : March 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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®)

  2. 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

  3. 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.

  4. 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.


Other Outcome Measures:
  1. Change of diastolic function parameters (E/A; E/E`) [ Time Frame: Change from baseline parameters at 12 weeks ]
    Echocardiography

  2. 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

  3. Change of serum biomarkers (hs-CRP, IL-6, IL-10, TNF-α) [ Time Frame: Change from baseline serum biomarkers at 12 weeks ]
    Blood sampling

  4. Change of cognitive Function [ Time Frame: Change from baseline cognitive function at 12 weeks ]
    Executive function test battery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796976


Locations
Layout table for location information
Switzerland
Bereich Sport- und Bewegungsmedizin, Abteilung Präventive Sportmedizin & Systemphysiologie
Basel, Basel Stadt, Switzerland, 4052
Sponsors and Collaborators
University of Basel
University Hospital, Basel, Switzerland
Basel Institute of Clinical Epidemiology (BICE)

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Henner Hanssen, Prof. Dr. med. Henner Hanssen, University of Basel
ClinicalTrials.gov Identifier: NCT02796976     History of Changes
Other Study ID Numbers: EKNZ-2015-351
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Henner Hanssen, University of Basel:
arterial stiffness
retinal vessels
physical activity
ageing

Additional relevant MeSH terms:
Layout table for MeSH terms
Inflammation
Cardiovascular Diseases
Atherosclerosis
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases