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

October 25, 2016 updated by: Sven Möbius-Winkler, University of Leipzig

Impact of Intensive Exercise Training Compared to Inactive Controls on Coronary Collateral Circulation and Plaque Composition in Patients With Significant Stable Coronary Artery Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04289
        • Heart Center Leipzig- University Leipzig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
coronary collateral blod flow
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
plaque composition within the coronary artery
Time Frame: 4 weeks
plaque composition measured by virtual histology intravascular ultrasound
4 weeks
MACCE
Time Frame: 4 week, 6 months, 12 months
major cardiovascular events (death, myocardial infarction, stroke, TIA, coronary revascularisation, hospitalisation)
4 week, 6 months, 12 months
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
4 weeks, 3, 6, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Investigators

  • Principal Investigator: Sven Möbius-Winkler, MD, Heart Center Leipzig- University Leipzig

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 24, 2010

First Submitted That Met QC Criteria

September 24, 2010

First Posted (Estimate)

September 27, 2010

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMW 04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stable Coronary Artery Disease

Clinical Trials on exercise training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe