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The Effect of Training on Endothelial Function, Progression of Disease,Inflammation, Heart Rate Variability and Mental Health After Percutaneous Coronary Intervention (EFECTOR)

This study has been completed.
Information provided by (Responsible Party):
Helse Stavanger HF Identifier:
First received: May 4, 2007
Last updated: April 13, 2015
Last verified: February 2009
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.

Condition Intervention Phase
Coronary Artery Disease
Behavioral: exercise training
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Exercise Training After Percutaneous Coronary Intervention

Resource links provided by NLM:

Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • flow mediated dilation, serum concentrations of biomarkers, restenosis-rate/ late luminal loss, heart rate variability in SDNN [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Oxygen uptake capacity (mg/kg/min), Sf36 scores [ Time Frame: 6 months ]

Estimated Enrollment: 40
Study Start Date: January 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: exercise training
    Exercise training in groups
Detailed Description:
Pas er randomized to a 6 months training group or none training. At baseline and at 6 months patients are examined with blood tests to measure serum concentrations of inflammatory markers, a test for endothelial function, heart rate variability and a coronary angiogram. Further patients are asked to answer questionnaires concerning mental health (SF36, HADS).

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Successful PCI with stent implantation,
  • Able to participate in the training program,
  • No planned further revascularisation

Exclusion Criteria:

  • CAGB,
  • Inflammatory diseases other than CAD,
  • Heart failure,
  • Severe kidney failure,
  • Inability to participate in the training program
  Contacts and Locations
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Please refer to this study by its identifier: NCT00469950

Stavanger University Hospital
Stavanger, Rogaland, Norway, 4022
Sponsors and Collaborators
Helse Stavanger HF
Principal Investigator: Peter S Munk, MD Helse Stavanger HF
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Helse Stavanger HF Identifier: NCT00469950     History of Changes
Other Study ID Numbers: 3.2005.1437
Study First Received: May 4, 2007
Last Updated: April 13, 2015

Keywords provided by Helse Stavanger HF:
endothelial function
late luminal loss
heart rate variability
oxygen uptake capacity
inflammatory markers

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on April 27, 2017