Skip to main content
OpenTrials
Completed

NCT Number: NCT01091194

Effect of Exercise After Heart Transplantation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Transplantation Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Cardiology, Oslo University Hospital, Rikshospitalet

Oslo, 0027, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interval-based aerobic exercise

Other

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 names: physical activity, fitness

Primary outcomes

  1. Peak oxygen uptake (VO2peak)

    Time frame: Before and after the intervention period of 1 year

Secondary outcomes

  1. Isokinetic muscle strength of quadriceps and hamstrings

    Time frame: Before and after the intervention period of 1 year

  2. Quality of life measured by questionnaires

    Time frame: Before and after the intervention period of 1 year

  3. Myocardial function measured by echocardiography

    Time frame: Before and after the intervention period of 1 year

  4. Progression on coronary atherosclerosis measured by intra vascular ultrasound (IVUS)

    Time frame: Before and after the intervention period of 1 year

  5. Vascular tone and compliance measured by tonometry

    Time frame: Before and after the intervention period of 1 year

  6. 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

  7. Analysis of isolated muscle cells from myocardial biopsy

    Time frame: Before and after the intervention period of 1 year

  8. Reinnervation as judged by autonomic nervous control (Heart Rate Variability)

    Time frame: Before and after the intervention period of 1 year

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Helse Sor-Ost

Registry information

Official study title

Effect of High Intensity Interval-based Aerobic Exercise 1-8 Years After Heart Transplantation. 1 Year Follow Up.

Acronym: TEX

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 23, 2010
Registry last updated
Feb 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.