NCT01228201

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 26, 2010

Completed
6 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

April 11, 2013

Status Verified

April 1, 2013

Enrollment Period

1.7 years

First QC Date

October 21, 2010

Last Update Submit

April 10, 2013

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Artery plaque composition evaluated by intravascular ultrasound and virtual histology

    Findings at 12 weeks will be compared to baseline results

    After 12 weeks

Secondary Outcomes (1)

  • Occurrence of in-stent restenosis related to endothelial dysfunction, inflammatory biomarkers and the dimension of the main left coronary artery

    After 12 weeks

Study Arms (2)

Aerboic interval training

EXPERIMENTAL
Behavioral: Aerobic interval training

Moderate continuous training

ACTIVE COMPARATOR
Behavioral: Moderate continuous training

Interventions

Moderate continuous trainingBEHAVIORAL

Three training sessions per week in a total of 12 weeks

Moderate continuous training
Aerobic interval trainingBEHAVIORAL

Three training sessions per week in a total of 12 weeks

Aerboic interval training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • stable or unstable coronary artery disease treated with percutaneous coronary intervention with stent implantation,
  • informed patient consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology

Trondheim, N-7006, Norway

Location

Related Publications (2)

  • 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.

    PMID: 19853690BACKGROUND

  • 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.

    PMID: 35226566DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Rune Wiseth, M.D, PhD

    Department of Cardiology, Trondheim University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Rune Wiseth

Study Record Dates

First Submitted

October 21, 2010

First Posted

October 26, 2010

Study Start

November 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

April 11, 2013

Record last verified: 2013-04

Locations

NO(1)