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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Rigshospitalet, Denmark.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01028599
First received: December 8, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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 Intervention
Heart Transplantation
Exercise Capacity
Endothelial Function
 Other: Intensive physical exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Physical Training on Oxygen Uptake and Endothelial Function in Heart Transplant Recipients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Change in maximal oxygen uptake. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change inm flow mediated vasodilatation. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2009
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise Other: Intensive physical exercise
Intensive physical exercise 1 hour three times per week

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.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028599

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

No publications provided

Responsible Party: Dr. Finn Gustafsson, Rigshospitalet
ClinicalTrials.gov Identifier: NCT01028599     History of Changes
Other Study ID Numbers: H-D-2009-004
Study First Received: December 8, 2009
Last Updated: December 8, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on June 17, 2013