Coronary Disease and the Effect of High-intensity Interval Training

NCT ID: NCT02494947

Last Updated: 2019-08-26

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-04-30

Brief Summary

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The primary purpose of this study is to investigate if systematic, high intensity, interval-based aerobic exercise training results in regression of lipid content of atherosclerotic coronary artery plaques, and in reduction of plaque burden in patients with stable coronary heart disease. Composition and morphologic characteristics of plaques will be studied by intra-coronary near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS) in patients undergoing percutaneous coronary intervention.

Detailed Description

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Conditions

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Coronary 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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interval training

high intensity interval-based aerobic exercise

Group Type EXPERIMENTAL

high intensity interval-based aerobic exercise

Intervention Type BEHAVIORAL

Interval exercises done 3 times weekly during 6 months according to standard procedures at the Department of Circulation and Medical Imaging.

Usual care

Intervention Type OTHER

controls

usual care

Group Type OTHER

Usual care

Intervention Type OTHER

Interventions

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high intensity interval-based aerobic exercise

Interval exercises done 3 times weekly during 6 months according to standard procedures at the Department of Circulation and Medical Imaging.

Intervention Type BEHAVIORAL

Usual care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* stable coronary artery disease
* will undergo cardiac catheterization
* will be treated with percutaneous coronary intervention (PCI)
* signed written informed consent
* able to execute the intervention

Exclusion Criteria

* earlier bypass surgery
* known inflammatory disease other than atherosclerosis
* planned surgery within 4 months
* included in another randomized controlled study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rune Wiseth, phd prof

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

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St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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Vesterbekkmo EK, Madssen E, Aamot Aksetoy IL, Follestad T, Nilsen HO, Hegbom K, Wisloff U, Wiseth R. CENIT (Impact of Cardiac Exercise Training on Lipid Content in Coronary Atheromatous Plaques Evaluated by Near-Infrared Spectroscopy): A Randomized Trial. J Am Heart Assoc. 2022 May 17;11(10):e024705. doi: 10.1161/JAHA.121.024705. Epub 2022 May 16.

Reference Type DERIVED
PMID: 35574968 (View on PubMed)

Other Identifiers

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2015/210

Identifier Type: -

Identifier Source: org_study_id

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