Department of General Surgery, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China.
School of Medicine, Jiangnan University, Wuxi, Jiangsu, China.
BMJ Open. 2024 May 21;14(5):e083228. doi: 10.1136/bmjopen-2023-083228.
Patients with liver cancer are susceptible to experiencing a decline in muscle mass and function, which can lead to physical frailty and have a negative impact on prognosis. However, there is currently a lack of physical activity interventions specifically tailored for these patients. Therefore, we have developed a modular multimodal hospital-home chain physical activity rehabilitation programme (3M2H-PARP) designed specifically for patients with liver cancer undergoing transarterial chemoembolisation (TACE). We aim to validate the effectiveness and feasibility of this programme through a randomised controlled trial (RCT).
3M2H-PARP RCT will compare a 12-week, modular, multimodal physical activity rehabilitation programme that includes supervised exercise in a hospital setting and self-management exercise at home. The programmes consist of aerobic, resistance, flexibility and balance exercise modules, and standard survivorship care in a cohort of liver cancer survivors who have undergone TACE. The control group will receive standard care. A total of 152 participants will be randomly assigned to either the 3M2H-PARP group or the control group. Assessments will be conducted at three time points: baseline, after completing the intervention and a 24-week follow-up visit. The following variables will be evaluated: liver frailty index, Functional Assessment of Cancer Therapy-Hepatobiliary subscale, Cancer Fatigue Scale, Pittsburgh Sleep Quality Index, Hospital Anxiety and Depression Scale and physical activity level. After the completion of the training programme, semi-structured interviews will be conducted with participants from the 3M2H-PARP group to investigate the programme's impact on their overall well-being. SPSS V.26.0 software will be used for statistical analyses.
Ethical approval has been granted by the Jiangnan University School of Medicine Research Ethics Committee. The findings will be disseminated through publication in a peer-reviewed journal.
ChiCTR2300076800.
肝癌患者易出现肌肉质量和功能下降，导致身体虚弱，并对预后产生负面影响。然而，目前针对这些患者的身体活动干预措施还比较缺乏。因此，我们专门为接受经动脉化疗栓塞（TACE）治疗的肝癌患者开发了一种模块化多模式医院-家庭链式身体活动康复方案（3M2H-PARP）。我们旨在通过随机对照试验（RCT）验证该方案的有效性和可行性。
3M2H-PARP RCT 将比较 12 周的模块化多模式身体活动康复方案，该方案包括在医院进行监督运动和在家进行自我管理运动。方案包括有氧运动、阻力运动、灵活性和平衡运动模块，以及 TACE 治疗后的肝癌幸存者的标准生存护理。对照组将接受标准护理。共有 152 名参与者将被随机分配到 3M2H-PARP 组或对照组。评估将在三个时间点进行：基线、干预完成后和 24 周随访。将评估以下变量：肝脆弱指数、癌症治疗功能评估-肝胆子量表、癌症疲劳量表、匹兹堡睡眠质量指数、医院焦虑和抑郁量表以及身体活动水平。完成培训计划后，将对 3M2H-PARP 组的参与者进行半结构化访谈，以调查该方案对他们整体健康的影响。SPSS V.26.0 软件将用于统计分析。
江南大学医学院研究伦理委员会已批准该研究的伦理。研究结果将通过发表在同行评议的期刊上进行传播。
ChiCTR2300076800。
