Heart Transplantation
Conditions
Keywords
Heart Transplantation, Aerobic Exercise, Exercise, Physical, Exercise Test, Treadmill Test, VO2 peak, Muscle Strength, Quality of Life, Reinnervation, Heart Rate, Myocardial Function
Brief summary
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.
Interventions
OTHERInterval-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.
Sponsors
Helse Sor-Ost
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak oxygen uptake (VO2peak) | Before and after the intervention period of 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Isokinetic muscle strength of quadriceps and hamstrings | 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 |
| Vascular tone and compliance measured by tonometry | Before and after the intervention period of 1 year |
Countries
Norway
Outcome results
None listed