Back to resultsPhysical Exercise and Coronary Artery Plaque Composition
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Moderate continuous training
Aerobic interval training
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
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
Sites / Locations
- Department of Cardiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Aerboic interval training
Moderate continuous training
Arm Description
Outcomes
Primary Outcome Measures
Artery plaque composition evaluated by intravascular ultrasound and virtual histology
Findings at 12 weeks will be compared to baseline results
Secondary Outcome Measures
Occurrence of in-stent restenosis related to endothelial dysfunction, inflammatory biomarkers and the dimension of the main left coronary artery
Findings at 12 weeks will be compared to baseline results
Full Information
NCT ID
NCT01228201
First Posted
October 21, 2010
Last Updated
April 10, 2013
Sponsor
Trondheim University Hospital
Collaborators
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT01228201
Brief Title
Physical Exercise and Coronary Artery Plaque Composition
Official Title
Physical Exercise and Coronary Artery Plaque Composition
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Trondheim University Hospital
Collaborators
Norwegian University of Science and Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aerboic interval training
Arm Type
Experimental
Arm Title
Moderate continuous training
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Moderate continuous training
Intervention Description
Three training sessions per week in a total of 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Aerobic interval training
Intervention Description
Three training sessions per week in a total of 12 weeks
Primary Outcome Measure Information:
Title
Artery plaque composition evaluated by intravascular ultrasound and virtual histology
Description
Findings at 12 weeks will be compared to baseline results
Time Frame
After 12 weeks
Secondary Outcome Measure Information:
Title
Occurrence of in-stent restenosis related to endothelial dysfunction, inflammatory biomarkers and the dimension of the main left coronary artery
Description
Findings at 12 weeks will be compared to baseline results
Time Frame
After 12 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rune Wiseth, M.D, PhD
Organizational Affiliation
Department of Cardiology, Trondheim University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology
City
Trondheim
ZIP/Postal Code
N-7006
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
19853690
Citation
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. doi: 10.1016/j.ahj.2009.08.021.
Results Reference
background
PubMed Identifier
35226566
Citation
Taraldsen MD, Wiseth R, Videm V, Bye A, Madssen E. Associations between circulating microRNAs and coronary plaque characteristics: potential impact from physical exercise. Physiol Genomics. 2022 Apr 1;54(4):129-140. doi: 10.1152/physiolgenomics.00071.2021. Epub 2022 Feb 28.
Results Reference
derived
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Physical Exercise and Coronary Artery Plaque Composition
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