TY - JOUR

T1 - Design and rationale of the HITTS randomized controlled trial

T2 - Effect of High-intensity Interval Training in de novo Heart Transplant Recipients in Scandinavia

AU - Nytrøen, Kari

AU - Yardley, Marianne

AU - Rolid, Katrine

AU - Bjørkelund, Elisabeth

AU - Karason, Kristjan

AU - Wigh, Julia Philip

AU - Dall, Christian Have

AU - Arora, Satish

AU - Aakhus, Svend

AU - Lunde, Ketil

AU - Solberg, Ole Geir

AU - Gustafsson, Finn

AU - Prescott, Eva Irene Bossano

AU - Gullestad, Lars

N1 - Copyright © 2015 Elsevier Inc. All rights reserved.

PY - 2016/2

Y1 - 2016/2

N2 - 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.

AB - 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.

KW - Exercise Therapy

KW - Heart Transplantation

KW - Humans

KW - Patient Education as Topic

KW - Postoperative Care

KW - Randomized Controlled Trials as Topic

KW - Research Design

KW - Scandinavian and Nordic Countries

KW - Transplant Recipients

KW - Journal Article

KW - Research Support, Non-U.S. Gov't

U2 - 10.1016/j.ahj.2015.10.011

DO - 10.1016/j.ahj.2015.10.011

M3 - Journal article

C2 - 26856221

VL - 172

SP - 96

EP - 105

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

ER -