Physical Exercise and Coronary Artery Plaque Composition

NCT ID: NCT01228201

Last Updated: 2013-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-07-31

Brief Summary

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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

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Aerboic interval training

Group Type EXPERIMENTAL

Aerobic interval training

Intervention Type BEHAVIORAL

Three training sessions per week in a total of 12 weeks

Moderate continuous training

Group Type ACTIVE_COMPARATOR

Moderate continuous training

Intervention Type BEHAVIORAL

Three training sessions per week in a total of 12 weeks

Interventions

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Moderate continuous training

Three training sessions per week in a total of 12 weeks

Intervention Type BEHAVIORAL

Aerobic interval training

Three training sessions per week in a total of 12 weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

Trondheim University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rune Wiseth

Professor Rune Wiseth

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rune Wiseth, M.D, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Trondheim University Hospital

Locations

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Department of Cardiology

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type BACKGROUND
PMID: 19853690 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35226566 (View on PubMed)

Other Identifiers

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NTNU - project no 46028000

Identifier Type: -

Identifier Source: org_study_id

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