Design and rationale of the HITTS randomized controlled trial: Effect of High-intensity Interval Training in de novo Heart Transplant Recipients in Scandinavia

• Published in: The American heart journal Vol. 172; pp. 96 - 105
• Main Authors: Nytrøen, Kari, Yardley, Marianne, Rolid, Katrine, Bjørkelund, Elisabeth, Karason, Kristjan, Wigh, Julia Philip, Dall, Christian Have, Arora, Satish, Aakhus, Svend, Lunde, Ketil, Solberg, Ole Geir, Gustafsson, Finn, Prescott, Eva Irene Bossano, Gullestad, Lars
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-02-2016
• Subjects: Exercise Therapy; Heart Transplantation - rehabilitation; Humans; Patient Education as Topic - methods; Postoperative Care - methods; Randomized Controlled Trials as Topic - methods; Research Design; Scandinavian and Nordic Countries; Transplant Recipients; Scandinavian and Nordic Countries
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2015.10.011

There is no consensus on how, when, and at what intensity exercise should be performed and organized after heart transplantation (HTx). Most rehabilitation programs are conducted in HTx centers, which might be impractical and costly. We have recently shown that high-intensity interval training (HIT) is safe, well tolerated, and efficacious in maintenance HTx recipients, but there are no studies among de novo patients, and whether HIT is feasible and superior to moderate training in HTx recipients is unclear.
A total of 120 clinically stable HTx recipients older than 18 years will be recruited from 3 Scandinavian HTx centers. Participants are randomized to HIT or moderate training, shortly after surgery. All exercises are supervised in the patients' local communities. Testing at baseline and follow-up includes the following: VO2peak (primary end point), muscle strength, body composition, quality of life, myocardial performance, endothelial function, biomarkers, and progression of cardiac allograft vasculopathy. A subgroup (n = 90) will also be tested at 3-year follow-up to assess long-term effects of exercise.
So far, the HIT intervention is well tolerated, without any serious adverse events. We aim to test whether decentralized HIT is feasible, safe, and superior to moderate training, and whether it will lead to significant improvement in exercise capacity and less long-term complications.