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
  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:


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
Study Completion Date: January 2010
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Rigshospitalet, Denmark

Additional 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 
Study First Received: December 8, 2009
Last Updated: October 26, 2015
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 February 11, 2016