Prehabilitation to improve outcomes afteR Autologous sTem cEll transplantation (PIRATE): A pilot randomised controlled trial protocol.

Autor: Dennett AM; School of Allied Health, Human Services and Sport, La Trobe University, Bundoora, Australia.; Allied Health Clinical Research Office, Eastern Health, Box Hill, Australia., Porter J; Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Burwood, Australia., Ting SB; Department of Clinical Haematology, Eastern Health, Box Hill, Australia.; Eastern Health Clinical School, Monash University, Box Hill, Australia., Taylor NF; School of Allied Health, Human Services and Sport, La Trobe University, Bundoora, Australia.; Allied Health Clinical Research Office, Eastern Health, Box Hill, Australia.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2023 Apr 27; Vol. 18 (4), pp. e0277760. Date of Electronic Publication: 2023 Apr 27 (Print Publication: 2023).
DOI: 10.1371/journal.pone.0277760
Abstrakt: Background: Autologous stem cell transplant is a common procedure for people with haematological malignancies. While effective at improving survival, autologous stem cell transplant recipients may have a lengthy hospital admission and experience debilitating side-effects such as fatigue, pain and deconditioning that may prolong recovery. Prehabilitation comprising exercise and nutrition intervention before stem cell transplant aims to optimise physical capacity before the procedure to enhance functional recovery after transplant. However, few studies have evaluated prehabilitation in this setting. We aim to explore preliminary efficacy of improving physical capacity of prehabilitation for people undergoing autologous stem cell transplant.
Methods: The PIRATE study is a single-blinded, parallel two-armed pilot randomised trial of multidisciplinary prehabilitation delivered prior to autologous stem cell transplantation. Twenty-two patients with haematological malignancy waitlisted for transplant will be recruited from a tertiary haematology unit. The intervention will include up to 8 weeks of twice-weekly, supervised tailored exercise and fortnightly nutrition education delivered via phone, in the lead up to autologous stem cell transplant. Blinded assessments will be completed at week 13, approximately 4 weeks after transplant and health service measures collected at week 25 approximately 12 weeks after transplant. The primary outcome is to assess changes in physical capacity using the 6-minute walk test. Secondary measures are time to engraftment, C-reactive protein, physical activity (accelerometer), grip strength, health-related quality of life (EORTC QLQ-C30 and HDC29 supplement), self-efficacy and recording of adverse events. Health service data including hospital length of stay, hospital readmissions, emergency department presentations and urgent symptom clinic presentation at will also be recorded.
Discussion: This trial will inform design of a future definitive randomised controlled trial and implementation of prehabilitation for people receiving autologous stem cell transplant by providing data on efficacy and safety.
Trial Registration: The PIRATE Trial has been approved by the Eastern Health Human Research Ethics Committee (E20/003/61055) and is funded by the Eastern Health Foundation. This trial is registered with the Australian New Zealand Clinical Trials Registry ACTRN12620000496910. Registered April 20, 2020.
Competing Interests: The authors have declared that no competing interests exist.
(Copyright: © 2023 Dennett et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
Databáze: MEDLINE
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