NCT01028599

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

3 months

First QC Date

December 8, 2009

Last Update Submit

October 26, 2015

Conditions

Heart TransplantationExercise CapacityEndothelial Function

Keywords

Heart transplantationExercise capacityEndothelial function

Outcome Measures

Primary Outcomes (1)

  • Change in maximal oxygen uptake.

    8 weeks

Secondary Outcomes (1)

  • Change inm flow mediated vasodilatation.

    8 weeks

Study Arms (1)

Exercise

EXPERIMENTAL
Other: Intensive physical exercise

Interventions

Intensive physical exerciseOTHER

Intensive physical exercise 1 hour three times per week

Exercise

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Heart transplant recipients \> 1 year after transplantation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Monk-Hansen T, Dall CH, Christensen SB, Snoer M, Gustafsson F, Rasmusen H, Prescott E. Interval training does not modulate diastolic function in heart transplant recipients. Scand Cardiovasc J. 2014 Apr;48(2):91-8. doi: 10.3109/14017431.2013.871058. Epub 2014 Jan 27.

    PMID: 24320690DERIVED

Study Officials

  • Finn Gustafsson, MD, PhD

    Department of Cardiology, Rigshospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 8, 2009

First Posted

December 9, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

October 28, 2015

Record last verified: 2015-10