The Effect of Training on Endothelial Function, Progression of Disease,Inflammation, Heart Rate Variability and Mental Health After Percutaneous Coronary Intervention
EFECTOR
Effect of Exercise Training After Percutaneous Coronary Intervention
1 other identifier
interventional
40
1 country
1
Brief Summary
The Efector study is an open, randomized and controlled trial assessing the effect of regular exercise training on endothelial function, inflammatory markers, progression of disease, heart rate variability and mental health in patients who have been successfully treated with percutaneous coronary intervention and stent implantation for angina pectoris.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 coronary-artery-disease
Started Jan 2006
Typical duration for phase_4 coronary-artery-disease
1 active site
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
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 4, 2007
CompletedFirst Posted
Study publicly available on registry
May 7, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedApril 14, 2015
February 1, 2009
3.1 years
May 4, 2007
April 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
flow mediated dilation, serum concentrations of biomarkers, restenosis-rate/ late luminal loss, heart rate variability in SDNN
6 months
Secondary Outcomes (1)
Oxygen uptake capacity (mg/kg/min), Sf36 scores
6 months
Interventions
Exercise training in groups
Eligibility Criteria
You may qualify if:
- Successful PCI with stent implantation,
- Able to participate in the training program,
- No planned further revascularisation
You may not qualify if:
- CAGB,
- Inflammatory diseases other than CAD,
- Heart failure,
- Severe kidney failure,
- Inability to participate in the training program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stavanger University Hospital
Stavanger, Rogaland, 4022, Norway
Related Publications (2)
Munk PS, Breland UM, Aukrust P, Ueland T, Kvaloy JT, Larsen AI. High intensity interval training reduces systemic inflammation in post-PCI patients. Eur J Cardiovasc Prev Rehabil. 2011 Dec;18(6):850-7. doi: 10.1177/1741826710397600. Epub 2011 Feb 18.
PMID: 21450602DERIVEDMunk 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: 19853690DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter S Munk, MD
Helse Stavanger HF
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2007
First Posted
May 7, 2007
Study Start
January 1, 2006
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
April 14, 2015
Record last verified: 2009-02