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Effect of Exercise After Heart Transplantation (TEX)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01091194
First Posted: March 23, 2010
Last Update Posted: February 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Helse Sor-Ost
Information provided by (Responsible Party):
Oslo University Hospital
  Purpose
This is a randomized controlled trial which will include approximately 50 heart transplant recipients 1-8 years after heart transplantation. The intervention and follow up period is 1 year. The primary purpose is to investigate if systematic, high intensity, interval-based aerobic exercise training results in a greater improvement of exercise capacity (measured by VO2peak) than previously shown in heart transplant recipients.

Condition Intervention Phase
Heart Transplantation Other: Interval-based aerobic exercise Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of High Intensity Interval-based Aerobic Exercise 1-8 Years After Heart Transplantation. 1 Year Follow Up.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Peak oxygen uptake (VO2peak) [ Time Frame: Before and after the intervention period of 1 year ]

Secondary Outcome Measures:
  • Isokinetic muscle strength of quadriceps and hamstrings [ Time Frame: Before and after the intervention period of 1 year ]
  • Quality of life measured by questionnaires [ Time Frame: Before and after the intervention period of 1 year ]
  • Myocardial function measured by echocardiography [ Time Frame: Before and after the intervention period of 1 year ]
  • Progression on coronary atherosclerosis measured by intra vascular ultrasound (IVUS) [ Time Frame: Before and after the intervention period of 1 year ]
  • Vascular tone and compliance measured by tonometry [ Time Frame: Before and after the intervention period of 1 year ]
  • Regular blood screening, lipid profile, inflammatory status, nerve growth factor, biochemical markers for endothelial function, prothrombotic factor, factors connected to vascularization: NT-proBNP and gene expression analysis. [ Time Frame: Before and after the intervention period of 1 year ]
  • Analysis of isolated muscle cells from myocardial biopsy [ Time Frame: Before and after the intervention period of 1 year ]
  • Reinnervation as judged by autonomic nervous control (Heart Rate Variability) [ Time Frame: Before and after the intervention period of 1 year ]

Enrollment: 51
Study Start Date: October 2009
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Exercise
Interval-based aerobic exercise
Other: Interval-based aerobic exercise
High intensity interval-based aerobic exercise training. Duration: 1 year. Three 8-weeks supervised periods of physical training 3 times per week. Individual training 2 times per week between these periods.
Other Name: physical activity, fitness
No Intervention: Control
No intervention other than regular follow up hospital visits

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Norwegian heart transplanted patients > 18 years of age
  • 1-8 years after heart transplantation
  • Optimal medical treatment
  • Stable condition
  • Written informed consent
  • Must have access to a physical therapist or personal trainer in their hometown
  • Motivation for exercise

Exclusion Criteria:

  • Unstable condition
  • In need of revascularization or other invention
  • Infections, open wounds or skin diseases
  • Physical disabilities which prevent participation
  • Other diseases, illnesses or conditions which contradict exercise
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01091194


Locations
Norway
Department of Cardiology, Oslo University Hospital, Rikshospitalet
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
Helse Sor-Ost
Investigators
Study Director: Lars Gullestad, MD,PhD,Prof. Oslo University Hospital