Effect of Exercise After Heart Transplantation (TEX)

This study has been completed.
Sponsor:
Collaborator:
Helse Sor-Ost
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01091194
First received: March 18, 2010
Last updated: February 18, 2013
Last verified: February 2013

March 18, 2010
February 18, 2013
October 2009
October 2011   (final data collection date for primary outcome measure)
Peak oxygen uptake (VO2peak) [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01091194 on ClinicalTrials.gov Archive Site
  • Isokinetic muscle strength of quadriceps and hamstrings [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
  • Quality of life measured by questionnaires [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
  • Myocardial function measured by echocardiography [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
  • Progression on coronary atherosclerosis measured by intra vascular ultrasound (IVUS) [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
  • Vascular tone and compliance measured by tonometry [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Analysis of isolated muscle cells from myocardial biopsy [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
  • Reinnervation as judged by autonomic nervous control (Heart Rate Variability) [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
  • Isokinetic muscle strength of quadriceps and hamstrings [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
  • Quality of life measured by questionnaires [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
  • Myocardial function measured by echocardiography [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
  • Progression on coronary atherosclerosis measured by IVUS [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
  • Vascular tone and compliance [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Analysis of isolated muscle cells from myocardial biopsy [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
  • Reinnervation as judged by autonomic nervous control (Heart Rate Variability) [ Time Frame: Before and after the intervention period of 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of Exercise After Heart Transplantation
Effect of High Intensity Interval-based Aerobic Exercise 1-8 Years After Heart Transplantation. 1 Year Follow Up.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Transplantation
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
  • Exercise
    Interval-based aerobic exercise
    Intervention: Other: Interval-based aerobic exercise
  • No Intervention: Control
    No intervention other than regular follow up hospital visits

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
December 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01091194
10920
No
Oslo University Hospital
Oslo University Hospital
Helse Sor-Ost
Study Director: Lars Gullestad, MD,PhD,Prof. Oslo University Hospital, Rikshospitalet
Oslo University Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP