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

Heart Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028599
• Other study ID #: H-D-2009-004
• Status: Completed
• Phase: N/A
• First received: December 8, 2009
• Last updated: October 26, 2015
• Start date: September 2009
• Est. completion date: January 2010

Study information

• Verified date: October 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Heart transplant recipients > 1 year after transplantation

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Endothelial Function
• Exercise Capacity
• Heart Transplantation

Intervention

Other:
• Intensive physical exercise
Intensive physical exercise 1 hour three times per week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in maximal oxygen uptake.		8 weeks	No
Secondary	Change inm flow mediated vasodilatation.		8 weeks	No