An interventional study of High Intensity Interval Training and Moderate Training in Heart Transplant Recipients and Physical Fitness, sponsored by Oslo University Hospital. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-09.
Sponsored by Oslo University Hospital · Not applicable, Interventional, and Prevention
Compared to end-stage heart failure, a patient's situation is usually greatly improved after a heart transplant (HTx), but the exercise capacity remains sub-normal, also long-term, ranging from 50 to 70% in most studies. While effective rehabilitation, including regular exercise, is considered an effective tool of improving health related quality of life (HRQoL) and prognosis of cardiac patients in general, the knowledge about and the effect of different rehabilitation programs among HTx recipients is limited. Exercise training is considered one of the most central parts in rehabilitation, but the mode of exercise used in different studies varies considerably. It is documented that high intensity interval training (HIT) has superior effects compared to training with moderate intensity in cardiac and heart failure patients. In contrast, HTx recipients have a denervated heart, and HIT had been considered unphysiological. However, the investigators have recently demonstrated highly beneficial effects on exercise capacity, muscle strength, body composition, reduced progression of cardiac allograft vasculopathy and HRQoL among long-term HTx recipients. In the present study the investigators want to test the hypothesis that systematic aerobic exercise with high intensity improve exercise capacity also in newly transplanted recipients, and secondarily that it gives favourable effects on the heart, peripheral circulation and a better HRQoL.
Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: High Intensity Interval Training
Regular exercise training offered as usual care to all heart transplant recipients.
Behavioral: Moderate Training
9 months of high intensity interval based aerobic exercise (3 times/week)
Also known as: Regular exercise training offered to all heart transplant recipients (usual care)
Effect of exercise on peak oxygen uptake
Change in ml/kg/min
Time frame: Baseline to one year
Effect of exercise on muscle strength
Change measured in Newtonmeter and Joule
Time frame: Baseline to one year
Effect of exercise on progression of coronary artery vasculopathy (CAV)
Change measured by intravascular ultrasound; change in maximum intimal thickness, total atheroma volume, percent atheroma volume and virtual histology.
Time frame: Baseline to one year
Effect of exercise on chronotropic responses
Change in heart rate response, including changes in minimum and maximum heart rate and changes in chronotropic response index.
Time frame: Baseline to one year
Effect of exercise on myocardial function
Change in echocardiographic parametres such as stroke volume, cardiac index and ejection fraction.
Time frame: Baseline to one year
Effect of exercise on endothelial function
Change in endothelial function measured by flow mediated dilatation and EndoPat
Time frame: Baseline to one year
Effect of exercise on biomarkers
Neuroendocrine, inflammatory and immunological biomarkers.
Time frame: Baseline to one year
Effect of exercise on health related quality of life
Change measured on visual analogue scales and questionnaires
Time frame: Baseline to one year
Effect of exercise on safety and tolerability
Measured by number of serious adverse effects related to the intervention
Time frame: Baseline to 3 years follow-up
Long-term effects of exercise
Long-term effects will be measured by all outcomes listed above, including number of serious adverse effects.
Time frame: Baseline to 3 years follow-up
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Oslo University Hospital