TY  - JOUR
A1  - Hill, Aileen
A1  - Dossow, Vera von
A1  - Heyland, Daren K.
A1  - Rossaint, Rolf
A1  - Meybohm, Patrick
A1  - Fox, Henrik
A1  - Morshuis, Michiel
A1  - Elke, Gunnar
A1  - Panholzer, Bernd
A1  - Haneya, Assad
A1  - Böning, Andreas
A1  - Niemann, Bernd
A1  - Zayat, Rashad
A1  - Moza, Ajay
A1  - Stoppe, Christian
T1  - Preoperative nutritional optimization and physical exercise for patients scheduled for elective implantation for a left-ventricular assist device — The PROPER-LVAD study
JF  - Surgeries
N2  - Background: Prehabilitation is gaining increasing interest and shows promising effects on short- and long-term outcomes among patients undergoing major surgery. The effect of multimodal, interdisciplinary prehabilitation has not yet been studied in patients with severe heart failure scheduled for the implantation of a left-ventricular assist device (LVAD). Methods: This randomized controlled multi-center study evaluates the effect of preoperative combined optimization of nutritional and functional status. Patients in the intervention group are prescribed daily in-bed cycling and oral nutrition supplements (ONS) from study inclusion until the day before LVAD-implantation. Patients in the control group receive standard of care treatment. The primary outcomes for the pilot study that involves 48 patients are safety (occurrence of adverse events), efficacy (group separation regarding the intake of macronutrients), feasibility of the trial protocol (compliance (percentage of received interventions) and confirmation of recruitment rates. Secondary outcomes include longitudinal measurements of muscle mass, muscle strength, physical function and quality of life, next to traditional clinical outcomes (30-day mortality, hospital and ICU length of stay, duration of mechanical ventilation and number of complications and infections). If the pilot study is successful, a larger confirmatory, international multicenter study is warranted.
KW  - prehabilitation
KW  - medical nutrition therapy
KW  - in-bed cycling
KW  - left-ventricular assist device
KW  - trial protocol
KW  - clinical trial
KW  - oral nutrition supplements
Y1  - 2022
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-288317
SN  - 2673-4095
N1  - Funding: This investigator-initiated trial is supported by a grant from Fresenius Kabi Deutschland (Fresenius Kabi Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg). The oral nutrition supplements (Fresubin PRO®) are provided by Fresenius Kabi Germany.
VL  - 3
IS  - 4
SP  - 284
EP  - 296
ER  -