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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01028599
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Heart Transplantation Exercise Capacity Endothelial Function Other: Intensive physical exercise

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Physical Training on Oxygen Uptake and Endothelial Function in Heart Transplant Recipients
Study Start Date : September 2009
Primary Completion Date : December 2009
Study Completion Date : January 2010

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Exercise Other: Intensive physical exercise
Intensive physical exercise 1 hour three times per week


Outcome Measures

Primary Outcome Measures :
  1. Change in maximal oxygen uptake. [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Change inm flow mediated vasodilatation. [ Time Frame: 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Heart transplant recipients > 1 year after transplantation

Exclusion Criteria:

  • Recent rejection, severe renal dysfunction, graft dysfunction, allograft vasculopathy, cancer, inability to exercise.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028599


Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Finn Gustafsson, MD, PhD Department of Cardiology, Rigshospitalet
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Finn Gustafsson, Dr, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01028599     History of Changes
Other Study ID Numbers: H-D-2009-004
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015

Keywords provided by Finn Gustafsson, Rigshospitalet, Denmark:
Heart transplantation
Exercise capacity
Endothelial function