Physical Exercise and Coronary Artery Plaque Composition

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01228201

Enrollment

Registered

2010-10-26

Start date

2010-11-30

Completion date

2012-07-31

Last updated

2013-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

BEHAVIORALModerate continuous training

Three training sessions per week in a total of 12 weeks

BEHAVIORALAerobic interval training

Three training sessions per week in a total of 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026