Physical Exercise and Coronary Artery Plaque Composition

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Behavioral: Aerobic interval training; Behavioral: Moderate continuous training

• Registration Number: NCT01228201
• Lead Sponsor: Trondheim University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-21
• Study First Submitted QC: 2010-10-25
• Study First Posted: 2010-10-26
• Study Start: 2010-11
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-10
• Last Update Posted: 2013-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerboic interval training	Aerobic interval training	-
Moderate continuous training	Moderate continuous training	-

Primary Outcome Measures

Name	Time	Method
Artery plaque composition evaluated by intravascular ultrasound and virtual histology	After 12 weeks	Findings at 12 weeks will be compared to baseline results

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Cardiology; 🇳🇴 Trondheim, Norway