Effect of Exercise After Heart Transplantation

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Transplantation

Intervention / Treatment
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* Other: Interval-based aerobic exercise


Participation Criteria
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Eligibility Criteria
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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

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Exercise<br>Interval-based aerobic exercise | Other: Interval-based aerobic exercise<br>* 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.<br>* Other names: physical activity, fitness;|
| No Intervention: Control<br>No intervention other than regular follow up hospital visits | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak oxygen uptake (VO2peak) |  | Before and after the intervention period of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isokinetic muscle strength of quadriceps and hamstrings |  | Before and after the intervention period of 1 year | 
| Quality of life measured by questionnaires |  | Before and after the intervention period of 1 year | 
| Myocardial function measured by echocardiography |  | Before and after the intervention period of 1 year | 
| Progression on coronary atherosclerosis measured by intra vascular ultrasound (IVUS) |  | Before and after the intervention period of 1 year | 
| Vascular tone and compliance measured by tonometry |  | Before and after the intervention period of 1 year | 
| 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. |  | Before and after the intervention period of 1 year | 
| Analysis of isolated muscle cells from myocardial biopsy |  | Before and after the intervention period of 1 year | 
| Reinnervation as judged by autonomic nervous control (Heart Rate Variability) |  | Before and after the intervention period of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Transplantation, Aerobic Exercise, Exercise, Physical, Exercise Test, Treadmill Test, VO2 peak, Muscle Strength, Quality of Life, Reinnervation, Heart Rate, Myocardial Function