Clinical trial NCT01091194: Effect of Exercise After Heart Transplantation
Official title: Effect of High Intensity Interval-based Aerobic Exercise 1-8 Years After Heart Transplantation. 1 Year Follow Up.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Transplantation
Keywords: Heart Transplantation
Aerobic Exercise
Exercise, Physical
Exercise Test
Treadmill Test
VO2 peak
Muscle Strength
Quality of Life
Reinnervation
Heart Rate
Myocardial Function
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Sor-Ost
First posted: 2010-03-23
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Peak oxygen uptake (VO2peak)
timeFrame: Before and after the intervention period of 1 year
Secondary outcomes:
measure: Isokinetic muscle strength of quadriceps and hamstrings
timeFrame: Before and after the intervention period of 1 year
measure: Quality of life measured by questionnaires
timeFrame: Before and after the intervention period of 1 year
measure: Myocardial function measured by echocardiography
timeFrame: Before and after the intervention period of 1 year
measure: Progression on coronary atherosclerosis measured by intra vascular ultrasound (IVUS)
timeFrame: Before and after the intervention period of 1 year
measure: Vascular tone and compliance measured by tonometry
timeFrame: Before and after the intervention period of 1 year
measure: 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.
timeFrame: Before and after the intervention period of 1 year
measure: Analysis of isolated muscle cells from myocardial biopsy
timeFrame: Before and after the intervention period of 1 year
measure: Reinnervation as judged by autonomic nervous control (Heart Rate Variability)
timeFrame: Before and after the intervention period of 1 year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Cardiology, Oslo University Hospital, Rikshospitalet
Study officials:
affiliation: Oslo University Hospital
name: Lars Gullestad, MD,PhD,Prof.
role: STUDY_DIRECTOR
References:
citation: Nytroen K, Rustad LA, Aukrust P, Ueland T, Hallen J, Holm I, Rolid K, Lekva T, Fiane AE, Amlie JP, Aakhus S, Gullestad L. High-intensity interval training improves peak oxygen uptake and muscular exercise capacity in heart transplant recipients. Am J Transplant. 2012 Nov;12(11):3134-42. doi: 10.1111/j.1600-6143.2012.04221.x. Epub 2012 Aug 17.
citation: Rustad LA, Nytroen K, Amundsen BH, Gullestad L, Aakhus S. One year of high-intensity interval training improves exercise capacity, but not left ventricular function in stable heart transplant recipients: a randomised controlled trial. Eur J Prev Cardiol. 2014 Feb;21(2):181-91. doi: 10.1177/2047487312469477. Epub 2012 Nov 26.
citation: Nytroen K, Rustad LA, Gude E, Hallen J, Fiane AE, Rolid K, Holm I, Aakhus S, Gullestad L. Muscular exercise capacity and body fat predict VO(2peak) in heart transplant recipients. Eur J Prev Cardiol. 2014 Jan;21(1):21-9. doi: 10.1177/2047487312450540. Epub 2012 Jun 1.
citation: Nytroen K, Rolid K, Yardley M, Gullestad L. Effect of high-intensity interval training in young heart transplant recipients: results from two randomized controlled trials. BMC Sports Sci Med Rehabil. 2020 Jun 4;12:35. doi: 10.1186/s13102-020-00180-1. eCollection 2020.