Physical Exercise and Coronary Artery Plaque Composition

April 10, 2013 updated by: Rune Wiseth, Trondheim University Hospital
The purpose of this study is to examine the effect of two different physical exercise protocols on changes in coronary artery plaque composition and development of in-stent restenosis in patients treated with percutaneous coronary intervention with stent implantation. The investigators will compare aerobic interval training and moderate continuous training. Both exercise protocols have a duration of 12 weeks. The investigators hypothesize that aerobic interval training is superior to moderate continuous training regarding effects on the composition of coronary artery plaques and a reduction in the development of in-stent restenosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

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

  • Norway
      • Trondheim, Norway, N-7006
        • Department of Cardiology

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • stable or unstable coronary artery disease treated with percutaneous coronary intervention with stent implantation,
  • informed patient consent

Exclusion Criteria:

  • ST-elevation myocardial infarction,
  • inability to give informed consent,
  • inability to participate in regular training due to residency, work situation or comorbidity,
  • any known chronic inflammatory disease other than atherosclerosis,
  • planned surgery within the next four months

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aerboic interval training
Behavioral: Aerobic interval training
Three training sessions per week in a total of 12 weeks
Active Comparator: Moderate continuous training
Behavioral: Moderate continuous training
Three training sessions per week in a total of 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Artery plaque composition evaluated by intravascular ultrasound and virtual histology
Time Frame: After 12 weeks
Findings at 12 weeks will be compared to baseline results
After 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of in-stent restenosis related to endothelial dysfunction, inflammatory biomarkers and the dimension of the main left coronary artery
Time Frame: After 12 weeks
Findings at 12 weeks will be compared to baseline results
After 12 weeks

Collaborators and Investigators

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

Sponsor

Trondheim University Hospital

Collaborators

Norwegian University of Science and Technology

Investigators

  • Principal Investigator: Rune Wiseth, M.D, PhD, Department of Cardiology, Trondheim University Hospital

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

November 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

October 21, 2010

First Submitted That Met QC Criteria

October 25, 2010

First Posted (Estimate)

October 26, 2010

Study Record Updates

Last Update Posted (Estimate)

April 11, 2013

Last Update Submitted That Met QC Criteria

April 10, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTNU - project no 46028000

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.

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