Is it feasible to conduct a randomised controlled trial of pretransplant exercise (prehabilitation) for patients with multiple myeloma awaiting autologous haematopoietic stem cell transplantation? Protocol for the PREeMPT study.
Is it feasible to conduct a randomised controlled trial of pretransplant exercise (prehabilitation) for patients with multiple myeloma awaiting autologous haematopoietic stem cell transplantation? Protocol for the PREeMPT study.
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DOI：
10.1136/bmjopen-2017-021333
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发表时间：
2018-03-09
期刊：
影响因子：
2.9
通讯作者：
Mawson S
中科院分区：
文献类型：
--
作者：
Keen C;Skilbeck J;Ross H;Smith L;Collins K;Dixey J;Walters S;Greenfield DM;Snowden JA;Mawson S
虽然骨髓瘤是一种无法治愈的恶性肿瘤，但近年来疾病管理的发展已导致预期寿命增加。治疗通常涉及干细胞移植。生存率的提高等同于更多的患者生活在疾病和治疗的负担下，使骨髓瘤成为一种长期疾病。有证据表明，运动对干细胞移植后恢复的患者有好处，而预防治疗前的运动在其他疾病领域也有效果。到目前为止，还没有关于等待移植治疗的骨髓瘤患者中的早产的研究。我们的目的是确定是否可以对等待自体干细胞移植的多发性骨髓瘤患者进行移植前运动的随机对照试验。这项混合方法研究确定了被分配到自体移植名单的诊断为多发性骨髓瘤的患者，并邀请他们在等待移植期间参加每周六次的个性化，监督运动。确定可行性目标的定量数据包括招募率、依从性和不良事件，以及包括6分钟步行距离测试和生活质量在内的结局指标。定性访谈进行了有目的的样本患者，以捕捉他们的经验的研究和干预。已获得伦理委员会批准。传播将通过开放获取的出版物和演示文稿，并将寻求达到多专业基地以及患者和护理人员团体，解决在这一研究领域的广泛兴趣。NCT 03135925;预结果。
While myeloma is an incurable malignancy, developments in disease management have led to increased life expectancy in recent years. Treatment typically involves stem-cell transplantation. Increased survival rates equate to more patients living with the burden of both the disease and its treatment for increasing number of years, rendering myeloma a long-term condition. Evidence exists to demonstrate the benefits of exercise for patients recovering from stem-cell transplantation, and prehabilitation—exercise before treatment—has been shown to be effective in other disease areas. To date there has been no research into prehabilitation in patients with myeloma awaiting transplantation treatment. Our objective is to determine whether it is feasible to conduct a randomised controlled trial into pretransplant exercise for patients with multiple myeloma who are awaiting autologous stem-cell transplantation. This mixed methods study identifies patients with diagnosis of multiple myeloma who have been assigned to the autologous transplantation list and invites them to participate in six weekly sessions of individualised, supervised exercise while awaiting transplantation. Quantitative data to determine feasibility targets include rates of recruitment, adherence and adverse events, and outcome measures including 6 min walking distance test and quality of life. Qualitative interviews are undertaken with a purposive sample of patients to capture their experiences of the study and the intervention. Ethics committee approval has been obtained. Dissemination will be through open-access publications and presentations and will seek to reach multiprofessional bases as well as patients and carer groups, addressing the widespread interest in this area of research. NCT03135925; Pre-results.
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