Jarden Mary, Møller Tom, Kjeldsen Lars, Birgens Henrik, Christensen Jesper Frank, Bang Christensen Karl, Diderichsen Finn, Hendriksen Carsten, Adamsen Lis
The University Hospitals Centre for Health Research UCSF, Department 9701, Copenhagen University Hospital (Rigshospitalet), Blegdamsvej 9, Copenhagen, DK-2100, Denmark.
BMC Cancer. 2013 Oct 2;13:446. doi: 10.1186/1471-2407-13-446.
Patients with acute leukemia experience a substantial symptom burden and are at risk of developing infections throughout the course of repeated cycles of intensive chemotherapy. Physical activity in recent years has been a strategy for rehabilitation in cancer patients to remedy disease and treatment related symptoms and side effects. To date, there are no clinical practice exercise guidelines for patients with acute leukemia undergoing induction and consolidation chemotherapy. A randomized controlled trial is needed to determine if patients with acute leukemia can benefit by a structured and supervised counseling and exercise program.
METHODS/DESIGN: This paper presents the study protocol: Patient Activation through Counseling and Exercise--Acute Leukemia (PACE-AL) trial, a two center, randomized controlled trial of 70 patients with acute leukemia (35 patients/study arm) following induction chemotherapy in the outpatient setting. Eligible patients will be randomized to usual care or to the 12 week exercise and counseling program. The intervention includes 3 hours + 30 minutes per week of supervised and structured aerobic training (moderate to high intensity 70-80%) on an ergometer cycle, strength exercises using hand weights and relaxation exercise. Individual health counseling sessions include a self directed home walk program with a step counter. The primary endpoint is functional performance/exercise capacity (6 minute walk distance). The secondary endpoints are submaximal VO₂ max test, sit to stand and bicep curl test, physical activity levels, patient reported outcomes (quality of life, anxiety and depression, symptom prevalence, intensity and interference). Evaluation of clinical outcomes will be explored including incidence of infection, hospitalization days, body mass index, time to recurrence and survival. Qualitative exploration of patients' health behavior and experiences.
PACE-AL will provide evidence of the effect of exercise and health promotion counseling on functional and physical capacity, the symptom burden and quality of life in patients with acute leukemia during out patient management. The results will inform clinical practice exercise guidelines and rehabilitation programs for patients undergoing treatment for acute leukemia. Optimizing the treatment and care pathway may ease the transition for patients from illness to the resumption of everyday activities.
ClinicalTrials.gov Identifier: NCT01404520.
急性白血病患者承受着巨大的症状负担，在强化化疗的反复疗程中面临感染风险。近年来，体育活动已成为癌症患者康复的一种策略，以缓解与疾病和治疗相关的症状及副作用。迄今为止，尚无针对接受诱导和巩固化疗的急性白血病患者的临床实践运动指南。需要进行一项随机对照试验，以确定急性白血病患者是否能从结构化且有监督的咨询和运动计划中获益。
方法/设计：本文介绍了研究方案：通过咨询和运动激活患者——急性白血病（PACE-AL）试验，这是一项在门诊环境中对70例急性白血病患者（每组35例）进行的两中心随机对照试验。符合条件的患者将被随机分配至常规护理组或为期12周的运动和咨询计划组。干预措施包括每周3小时+30分钟在测力计自行车上进行的有监督且结构化的有氧训练（中等至高强度70-80%）、使用哑铃的力量训练和放松训练。个体健康咨询课程包括一个使用计步器的自主居家步行计划。主要终点是功能表现/运动能力（6分钟步行距离）。次要终点是次极量VO₂ max测试、坐立试验和二头肌卷曲试验、身体活动水平、患者报告的结果（生活质量、焦虑和抑郁、症状发生率、强度和干扰）。将探索对临床结局的评估，包括感染发生率、住院天数、体重指数、复发时间和生存率。对患者健康行为和经历的定性探索。
PACE-AL将提供证据，证明运动和健康促进咨询对急性白血病患者门诊管理期间的功能和身体能力、症状负担及生活质量的影响。研究结果将为急性白血病患者的临床实践运动指南和康复计划提供参考。优化治疗和护理途径可能会缓解患者从患病到恢复日常活动的过渡。
ClinicalTrials.gov标识符：NCT01404520。
