School of Allied Health, Human Services and Sport, La Trobe University, Bundoora, Australia.
Allied Health Clinical Research Office, Eastern Health, Box Hill, Australia.
PLoS One. 2023 Apr 27;18(4):e0277760. doi: 10.1371/journal.pone.0277760. eCollection 2023.
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.
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.
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.
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.
自体干细胞移植是治疗血液恶性肿瘤患者的常用方法。虽然自体干细胞移植在提高生存率方面非常有效，但移植受者可能需要长时间住院，并经历疲劳、疼痛和功能下降等使人虚弱的副作用，这可能会延长康复时间。干细胞移植前的预康复包括运动和营养干预，旨在术前优化身体能力，以增强移植后的功能恢复。然而，很少有研究评估过这种情况下的预康复。我们旨在探讨预康复改善接受自体干细胞移植患者身体能力的初步效果。
PIRATE 研究是一项单盲、平行双臂、试点随机试验，对接受自体干细胞移植的患者进行多学科预康复。将从一家三级血液科招募 22 名等待移植的血液恶性肿瘤患者。该干预措施将包括最多 8 周的每周两次、监督定制的运动和每两周一次的电话营养教育，在自体干细胞移植前进行。盲法评估将在移植后第 13 周（约 4 周后）进行，健康服务措施将在移植后第 25 周（约 12 周后）收集。主要结果是使用 6 分钟步行测试评估身体能力的变化。次要结果是植入时间、C 反应蛋白、身体活动（加速度计）、握力、健康相关生活质量（EORTC QLQ-C30 和 HDC29 补充）、自我效能和不良事件记录。还将记录健康服务数据，包括住院时间、住院再入院、急诊就诊和紧急症状诊所就诊。
该试验将通过提供疗效和安全性数据，为未来的确定性随机对照试验设计和自体干细胞移植患者的预康复实施提供信息。
PIRATE 试验已获得东澳大利亚健康人体研究伦理委员会（E20/003/61055）的批准，并得到东澳大利亚健康基金会的资助。该试验在澳大利亚和新西兰临床试验注册中心（ACTRN12620000496910）注册。于 2020 年 4 月 20 日注册。
