High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia

Study Overview
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Brief Summary
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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.

Official Title
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High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia

Conditions
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Heart Transplant Recipients, Physical Fitness

Intervention / Treatment
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* Behavioral: High Intensity Interval Training
* Behavioral: Moderate Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically stable HTx recipients approximately 8-12 weeks after HTx. Age > 18 years, both sexes Received immunosuppressive therapy as per local protocol. Patient willing and capable of giving written informed consent for study participation and anticipated to be able to participate in the study for 9- 12 months. Exclusion Criteria: Unstable condition or postoperative complications Recent severe rejection episodes Physical disabilities which prevent participation Other diseases or disabilities that contradict/refrain from exercise.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Intensity Interval Training<br> | Behavioral: High Intensity Interval Training<br>* 9 months of high intensity interval based aerobic exercise (3 times/week)<br>|
| Other: Moderate Training<br>Regular exercise training offered as usual care to all heart transplant recipients. | Behavioral: Moderate Training<br> <br> * Other names: Regular exercise training offered to all heart transplant recipients (usual care);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of exercise on peak oxygen uptake | Change in ml/kg/min | Baseline to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of exercise on muscle strength | Change measured in Newtonmeter and Joule | 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. | 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. | Baseline to one year | 
| Effect of exercise on myocardial function | Change in echocardiographic parametres such as stroke volume, cardiac index and ejection fraction. | Baseline to one year | 
| Effect of exercise on endothelial function | Change in endothelial function measured by flow mediated dilatation and EndoPat | Baseline to one year | 
| Effect of exercise on biomarkers | Neuroendocrine, inflammatory and immunological biomarkers. | Baseline to one year | 
| Effect of exercise on health related quality of life | Change measured on visual analogue scales and questionnaires | Baseline to one year | 
| Effect of exercise on safety and tolerability | Measured by number of serious adverse effects related to the intervention | 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. | Baseline to 3 years follow-up |