Effect of Physical Training on Oxygen Uptake and Endothelial Function in Heart Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Finn Gustafsson, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01028599
First received: December 8, 2009
Last updated: October 26, 2015
Last verified: October 2015

December 8, 2009
October 26, 2015
September 2009
December 2009   (final data collection date for primary outcome measure)
Change in maximal oxygen uptake. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01028599 on ClinicalTrials.gov Archive Site
Change inm flow mediated vasodilatation. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Physical Training on Oxygen Uptake and Endothelial Function in Heart Transplant Recipients
Effect of Physical Training on Oxygen Uptake and Endothelial Function in Heart Transplant Recipients
The purpose of this study is to investigate the effect of physical training on work capacity and vascular function after heart transplantation, cardiac transplant recipients are randomized to 8 weeks of intense physical training or control. Vascular function is measured non-invasively. Effect on the hormones and the immune system is evaluated using blood samples.
To investigate the effect of physical training on work capacity and vascular function after heart transplantation, cardiac transplant recipients are randomized to 8 weeks of intense physical training or control. Vascular function is measured non-invasively using forearm flow mediated dilatation. Effect on the blood natriuretic peptides and the inflammatory markers is evaluated using blood samples at baseline and after the training or control period.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Heart Transplantation
  • Exercise Capacity
  • Endothelial Function
Other: Intensive physical exercise
Intensive physical exercise 1 hour three times per week
Experimental: Exercise
Intervention: Other: Intensive physical exercise
Monk-Hansen T, Dall CH, Christensen SB, Snoer M, Gustafsson F, Rasmusen H, Prescott E. Interval training does not modulate diastolic function in heart transplant recipients. Scand Cardiovasc J. 2014 Apr;48(2):91-8. doi: 10.3109/14017431.2013.871058. Epub 2014 Jan 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Heart transplant recipients > 1 year after transplantation

Exclusion Criteria:

  • Recent rejection, severe renal dysfunction, graft dysfunction, allograft vasculopathy, cancer, inability to exercise.
Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01028599
H-D-2009-004
No
Not Provided
Not Provided
Finn Gustafsson, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Not Provided
Principal Investigator: Finn Gustafsson, MD, PhD Department of Cardiology, Rigshospitalet
Rigshospitalet, Denmark
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP