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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Rikshospitalet
  More Information