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Physical Exercise and Coronary Artery Plaque Composition

Sponsor
Trondheim University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01228201
Collaborator
Norwegian University of Science and Technology (Other)
40
Enrollment
1
Location
2
Arms
20
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Moderate continuous training
  • Behavioral: Aerobic interval training
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Physical Exercise and Coronary Artery Plaque Composition
Study Start Date :
Nov 1, 2010
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Jul 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Aerboic interval training

Behavioral: Aerobic interval training
Three training sessions per week in a total of 12 weeks
Active Comparator: Moderate continuous training

Behavioral: Moderate continuous training
Three training sessions per week in a total of 12 weeks

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Cardiology Trondheim Norway N-7006

Sponsors and Collaborators

  • Trondheim University Hospital
  • Norwegian University of Science and Technology

Investigators

  • Principal Investigator: Rune Wiseth, M.D, PhD, Department of Cardiology, Trondheim University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rune Wiseth, Professor Rune Wiseth, Trondheim University Hospital
ClinicalTrials.gov Identifier:
NCT01228201
Other Study ID Numbers:
  • NTNU - project no 46028000
First Posted:
Oct 26, 2010
Last Update Posted:
Apr 11, 2013
Last Verified:
Apr 1, 2013
Additional relevant MeSH terms:
Coronary Artery Disease

Study Results

No Results Posted as of Apr 11, 2013