title: Design and rationale of the HITTS randomized controlled trial: Effect of High-intensity Interval Training in de novo Heart Transplant Recipients in Scandinavia.
abstract: 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.
authors: Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, University of Oslo, Oslo, Norway. Electronic address: knytroen@gmail.com.
authors: Kari
authors: K
authors: Nytrøen
authors: Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, University of Oslo, Oslo, Norway.
authors: Marianne
authors: M
authors: Yardley
authors: Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
authors: Katrine
authors: K
authors: Rolid
authors: Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
authors: Elisabeth
authors: E
authors: Bjørkelund
authors: Sahlgrenska University Hospital, Gothenburg, Sweden.
authors: Kristjan
authors: K
authors: Karason
authors: Sahlgrenska University Hospital, Gothenburg, Sweden.
authors: Julia Philip
authors: JP
authors: Wigh
authors: Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark.
authors: Christian Have
authors: CH
authors: Dall
authors: Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
authors: Satish
authors: S
authors: Arora
authors: Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
authors: Svend
authors: S
authors: Aakhus
authors: Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
authors: Ketil
authors: K
authors: Lunde
authors: Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
authors: Ole Geir
authors: OG
authors: Solberg
authors: Rigshospitalet University Hospital, Copenhagen, Denmark.
authors: Finn
authors: F
authors: Gustafsson
authors: Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark.
authors: Eva Irene Bossano
authors: EI
authors: Prescott
authors: Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, University of Oslo, Oslo, Norway.
authors: Lars
authors: L
authors: Gullestad
mesh_terms: D005081:Exercise Therapy; D016027:Heart Transplantation / Q000534:rehabilitation*; D006801:Humans; D010353:Patient Education as Topic / Q000379:methods*; D011182:Postoperative Care / Q000379:methods*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D012537:Scandinavian and Nordic Countries; D066027:Transplant Recipients