Larsen Rikke Faebo, Jarden Mary, Minet Lisbeth Rosenbek, Frølund Ulf Christian, Abildgaard Niels
1Department of Physiotherapy and Occupational Therapy, Zealand University Hospital, Sygehusvej 10, 4000 Roskilde, Denmark.
2Department of Clinical Research, University of Southern Denmark, Campusvej 55, 5230 Odense M, Denmark.
Pilot Feasibility Stud. 2019 Nov 12;5:130. doi: 10.1186/s40814-019-0518-2. eCollection 2019.
The study evaluated the feasibility and safety of the exercise intervention and physical test procedures of our ongoing randomized controlled trial, examining the effect of physical exercise in newly diagnosed patients with multiple myeloma.
Patients are randomized 1:1 to a control group (usual care) or an intervention group (usual care and exercise) by block randomization with stratification of planned treatment, WHO performance status, and study site. The exercise intervention consists of eight supervised exercise sessions combined with home-based exercise over a 10-week period. Bone disease is systematically evaluated to determine limitations regarding physical testing and/or exercise. Feasibility outcome measures were study eligibility, acceptance, and attrition, and furthermore attendance, adherence, tolerability, and safety to the exercise intervention. Additionally, test completion, pain, and adverse events during the physical test procedures were evaluated. Outcome assessors were blinded to allocation.
Of 49 patients screened, 30 were included. The median age was 69 years, range 38-90, 77% were males, and 67% had bone disease. Study eligibility was 82%, acceptance 75%, and attrition 20%. Attendance at supervised exercise sessions was 92%, and adherence to supervised exercise sessions and home-based exercise sessions was 99% and 89%, respectively. No serious adverse events attributed to exercise or physical tests were reported. All patients completed the physical tests, except for two patients, where physical test procedures were modified due to bone disease.
The exercise intervention and physical test procedures were feasible and safe in patients with multiple myeloma, even in older patients with multiple myeloma and in patients with myeloma bone disease.
ClinicalTrials.gov. ID NCT02439112. Registered on May 7, 2015.
本研究评估了我们正在进行的随机对照试验的运动干预和身体测试程序的可行性与安全性，该试验旨在研究体育锻炼对新诊断的多发性骨髓瘤患者的影响。
通过分层区组随机化将患者按1:1随机分配至对照组（常规护理）或干预组（常规护理加运动），分层因素包括计划治疗方案、世界卫生组织体能状态及研究地点。运动干预包括在10周内进行8次有监督的运动课程，并结合家庭运动。对骨病进行系统评估，以确定身体测试和/或运动的限制因素。可行性结果指标包括研究入选情况、接受程度、损耗率，此外还有运动干预的出勤情况、依从性、耐受性和安全性。另外，还评估了身体测试程序期间的测试完成情况、疼痛及不良事件。结果评估人员对分组情况不知情。
在49例筛查患者中，30例被纳入研究。中位年龄为69岁，范围为38 - 90岁，77%为男性，67%患有骨病。研究入选率为82%，接受率为75%，损耗率为20%。有监督运动课程的出勤率为92%，对有监督运动课程和家庭运动课程的依从率分别为99%和89%。未报告因运动或身体测试导致的严重不良事件。除两名患者因骨病修改了身体测试程序外，所有患者均完成了身体测试。
运动干预和身体测试程序在多发性骨髓瘤患者中是可行且安全的，即使在老年多发性骨髓瘤患者及骨髓瘤骨病患者中也是如此。
ClinicalTrials.gov。标识符NCT02439112。于2015年5月7日注册。
