Clinical trial NCT01796379: High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia
Official title: High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Transplant Recipients
Physical Fitness
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
name: Norwegian Health Association
First posted: 2013-02-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Effect of exercise on peak oxygen uptake
timeFrame: Baseline to one year
Secondary outcomes:
measure: Effect of exercise on muscle strength
timeFrame: Baseline to one year
measure: Effect of exercise on progression of coronary artery vasculopathy (CAV)
timeFrame: Baseline to one year
measure: Effect of exercise on chronotropic responses
timeFrame: Baseline to one year
measure: Effect of exercise on myocardial function
timeFrame: Baseline to one year
measure: Effect of exercise on endothelial function
timeFrame: Baseline to one year
measure: Effect of exercise on biomarkers
timeFrame: Baseline to one year
measure: Effect of exercise on health related quality of life
timeFrame: Baseline to one year
measure: Effect of exercise on safety and tolerability
timeFrame: Baseline to 3 years follow-up
measure: Long-term effects of exercise
timeFrame: Baseline to 3 years follow-up
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital Rikshospitalet
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Oslo Unversity Hospital
name: Lars Gullestad, Professor
role: PRINCIPAL_INVESTIGATOR
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: Nytroen K, Yardley M, Rolid K, Bjorkelund E, Karason K, Wigh JP, Dall CH, Arora S, Aakhus S, Lunde K, Solberg OG, Gustafsson F, Prescott EI, Gullestad L. Design and rationale of the HITTS randomized controlled trial: Effect of High-intensity Interval Training in de novo Heart Transplant Recipients in Scandinavia. Am Heart J. 2016 Feb;172:96-105. doi: 10.1016/j.ahj.2015.10.011. Epub 2015 Oct 21.
citation: Rolid K, Andreassen AK, Yardley M, Bjorkelund E, Karason K, Wigh JP, Dall CH, Gustafsson F, Gullestad L, Nytroen K. Clinical features and determinants of VO2peak in de novo heart transplant recipients. World J Transplant. 2018 Sep 10;8(5):188-197. doi: 10.5500/wjt.v8.i5.188.
citation: Rolid K, Andreassen AK, Yardley M, Gude E, Bjorkelund E, Authen AR, Grov I, Pettersen KI, Dall CH, Karason K, Broch K, Gullestad L, Nytroen K. High-intensity interval training and health-related quality of life in de novo heart transplant recipients - results from a randomized controlled trial. Health Qual Life Outcomes. 2020 Aug 17;18(1):283. doi: 10.1186/s12955-020-01536-4.
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.
citation: Rolid K, Andreassen AK, Yardley M, Gude E, Bjorkelund E, Authen AR, Grov I, Broch K, Gullestad L, Nytroen K. Long-term effects of high-intensity training vs moderate intensity training in heart transplant recipients: A 3-year follow-up study of the randomized-controlled HITTS study. Am J Transplant. 2020 Dec;20(12):3538-3549. doi: 10.1111/ajt.16087. Epub 2020 Jun 28.
citation: Nytroen K, Rolid K, Andreassen AK, Yardley M, Gude E, Dahle DO, Bjorkelund E, Relbo Authen A, Grov I, Philip Wigh J, Have Dall C, Gustafsson F, Karason K, Gullestad L. Effect of High-Intensity Interval Training in De Novo Heart Transplant Recipients in Scandinavia. Circulation. 2019 May 7;139(19):2198-2211. doi: 10.1161/CIRCULATIONAHA.118.036747.