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
Recruitment status was Active, not recruiting
Sponsor:
Rigshospitalet, Denmark
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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 8, 2009 | ||||
| Last Updated Date | December 8, 2009 | ||||
| Start Date ICMJE | September 2009 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in maximal oxygen uptake. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Change inm flow mediated vasodilatation. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Physical Training on Oxygen Uptake and Endothelial Function in Heart Transplant Recipients | ||||
| Official Title ICMJE | Effect of Physical Training on Oxygen Uptake and Endothelial Function in Heart Transplant Recipients | ||||
| 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. |
||||
| 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 Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Other: Intensive physical exercise
Intensive physical exercise 1 hour three times per week |
||||
| Study Arm (s) | Experimental: Exercise
Intervention: Other: Intensive physical exercise |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | January 2010 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01028599 | ||||
| Other Study ID Numbers ICMJE | H-D-2009-004 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Finn Gustafsson, Rigshospitalet | ||||
| Study Sponsor ICMJE | Rigshospitalet, Denmark | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Rigshospitalet, Denmark | ||||
| Verification Date | September 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||