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Physical Exercise and Coronary Artery Plaque Composition

This study has been completed.
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
Rune Wiseth, Trondheim University Hospital
ClinicalTrials.gov Identifier:
NCT01228201
First received: October 21, 2010
Last updated: April 10, 2013
Last verified: April 2013

October 21, 2010
April 10, 2013
November 2010
July 2012   (final data collection date for primary outcome measure)
Artery plaque composition evaluated by intravascular ultrasound and virtual histology [ Time Frame: After 12 weeks ] [ Designated as safety issue: Yes ]
Findings at 12 weeks will be compared to baseline results
Same as current
Complete list of historical versions of study NCT01228201 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Findings at 12 weeks will be compared to baseline results
Same as current
Not Provided
Not Provided
 
Physical Exercise and Coronary Artery Plaque Composition
Physical Exercise and Coronary Artery Plaque Composition

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Coronary Artery Disease
  • Behavioral: Moderate continuous training
    Three training sessions per week in a total of 12 weeks
  • Behavioral: Aerobic interval training
    Three training sessions per week in a total of 12 weeks
  • Experimental: Aerboic interval training
    Intervention: Behavioral: Aerobic interval training
  • Active Comparator: Moderate continuous training
    Intervention: Behavioral: Moderate continuous training
Munk PS, Staal EM, Butt N, Isaksen K, Larsen AI. High-intensity interval training may reduce in-stent restenosis following percutaneous coronary intervention with stent implantation A randomized controlled trial evaluating the relationship to endothelial function and inflammation. Am Heart J. 2009 Nov;158(5):734-41.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01228201
NTNU - project no 46028000
No
Rune Wiseth, Trondheim University Hospital
Trondheim University Hospital
Norwegian University of Science and Technology
Principal Investigator: Rune Wiseth, M.D, PhD Department of Cardiology, Trondheim University Hospital
Trondheim University Hospital
April 2013

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