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Impact of Intensive Exercise Training on Coronary Collateral Circulation in Patients With Stable CAD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01209637
First Posted: September 27, 2010
Last Update Posted: October 26, 2016
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.
Information provided by (Responsible Party):
Sven Möbius-Winkler, University of Leipzig
  Purpose

Exercise training in patients with coronary artery disease is able to correct several risk factors. Furthermore endothelial function can be improved.

There are some hinds for improved collateral circulation after exercise training, nevertheless there is no study showing significant improvement/ increase in coronary collaterals. This might be due to technique of collateral measurement. Therefore we conduct a study were coronary blod flow before and after 4 weeks of exercise training were measured.


Condition Intervention
Stable Coronary Artery Disease Behavioral: exercise training Behavioral: Intensive exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Intensive Exercise Training Compared to Inactive Controls on Coronary Collateral Circulation and Plaque Composition in Patients With Significant Stable Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by Sven Möbius-Winkler, University of Leipzig:

Primary Outcome Measures:
  • coronary collateral blod flow [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • plaque composition within the coronary artery [ Time Frame: 4 weeks ]
    plaque composition measured by virtual histology intravascular ultrasound

  • MACCE [ Time Frame: 4 week, 6 months, 12 months ]
    major cardiovascular events (death, myocardial infarction, stroke, TIA, coronary revascularisation, hospitalisation)

  • atherosclerosis parameter within the laboratory [ Time Frame: 4 weeks, 3, 6, 12 months ]
    e.g. wie hs-CRP, HDL, LDL, ges. Cholesterin, Triglyceride, Zytokine, Adipokine, Endocannaboide


Enrollment: 60
Study Start Date: March 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
standard care of coronary artery diseases incl. recommended home based exercise 3x/week
Active Comparator: Exercise training
exercise training for 4 weeks at 70% of ischemia free individual threshold within a rehabilitation care center
Behavioral: exercise training
exercise training min. 4 times a day for at least 30 min
Active Comparator: intensive exercise training
intensive exercise training incl. interval training
Behavioral: Intensive exercise training
Intensive exercise training for 4 times / day incl. interval training at 95% individual threshold

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stable CAD
  • min.1 coronary artery stenosis >50%
  • patient is symptomatic ( CCS 1-3)or has documented myocardial ischemia during stress test
  • angina threshold >75 Watt
  • informed consent

Exclusion Criteria:

  • Age <18 oder >75
  • akut coronary syndrome within 2 weeks
  • LV-EF < 40 %
  • significant valve diseases
  • reduced patient compliance
  • muscular disorder
  • bronchial asthma or COLD stadium III and IV
  Contacts and Locations
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): NCT01209637


Locations
Germany
Heart Center Leipzig- University Leipzig
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Sven Möbius-Winkler, MD Heart Center Leipzig- University Leipzig
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sven Möbius-Winkler, PI, University of Leipzig
ClinicalTrials.gov Identifier: NCT01209637     History of Changes
Other Study ID Numbers: SMW 04
First Submitted: September 24, 2010
First Posted: September 27, 2010
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Sven Möbius-Winkler, University of Leipzig:
stable coronary artery disease
significant coronary stenosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases