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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
History of Changes
  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:

U.S. FDA Resources

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
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

Publications:

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01091194     History of Changes
Other Study ID Numbers: 10920
Study First Received: March 18, 2010
Last Updated: February 18, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Heart Transplantation
Aerobic Exercise
Exercise, Physical
Exercise Test
Treadmill Test
VO2 peak
 Muscle Strength
Quality of Life
Reinnervation
Heart Rate
Myocardial Function

ClinicalTrials.gov processed this record on June 18, 2013