van Waart Hanna, Stuiver Martijn M, van Harten Wim H, Geleijn Edwin, de Maaker-Berkhof Marianne, Schrama Jolanda, Geenen Maud M, Meerum Terwogt Jetske M, van den Heiligenberg Simone M, Hellendoorn-van Vreeswijk Jeannette A J H, Sonke Gabe S, Aaronson Neil K
Division of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Department of Physical Therapy, Netherlands Cancer Institute, Amsterdam, The Netherlands.
Int J Colorectal Dis. 2018 Jan;33(1):29-40. doi: 10.1007/s00384-017-2921-6. Epub 2017 Nov 9.
We report the recruitment rate, reasons for and factors influencing non-participation, and descriptive results of a randomized controlled trial of two different exercise programs for patients with colon cancer undergoing adjuvant chemotherapy.
Participants were randomized to a low-intensity, home-based program (Onco-Move), a moderate- to high-intensity, combined supervised resistance and aerobic exercise program (OnTrack), or Usual Care. Non-participants provided reasons for non-participation and were asked to complete a questionnaire assessing behavioral and attitudinal variables. Trial participants completed performance-based and self-reported outcome measures prior to randomization, at the end of chemotherapy, and at the 6-month follow-up.
Twenty-three of 63 referred patients agreed to participate in the trial. All 40 non-participants provided reasons for non-participation. Forty-five percent of the non-participants completed the questionnaire. Those who did not want to exercise had higher fatigue scores at baseline and a more negative attitude toward exercise. Compliance to both programs was high and no adverse events occurred. On average, the colon cancer participants were able to maintain or improve their physical fitness levels and maintain or decrease their fatigue levels during chemotherapy and follow-up.
Recruitment of patients with colon cancer to a physical exercise trial during adjuvant chemotherapy proved to be difficult, underscoring the need to develop more effective strategies to increase participation rates. Both home-based and supervised programs are safe and feasible in patients with colon cancer undergoing chemotherapy. Effectiveness needs to be established in a larger trial.
Netherlands Trial Register - NTR2159.
我们报告了一项针对接受辅助化疗的结肠癌患者的两种不同运动方案的随机对照试验的招募率、不参与的原因和影响因素，以及描述性结果。
参与者被随机分配到低强度居家运动方案（Onco-Move）、中高强度的有监督的抗阻与有氧运动联合方案（OnTrack）或常规护理组。不参与者提供了不参与的原因，并被要求完成一份评估行为和态度变量的问卷。试验参与者在随机分组前、化疗结束时以及6个月随访时完成基于表现和自我报告的结局测量。
63名被转诊患者中有23名同意参加试验。所有40名不参与者都提供了不参与的原因。45%的不参与者完成了问卷。那些不想运动的人在基线时疲劳得分更高，对运动的态度更消极。两个方案的依从性都很高，且未发生不良事件。平均而言，结肠癌参与者在化疗和随访期间能够维持或提高其体能水平，并维持或降低其疲劳水平。
事实证明，在辅助化疗期间招募结肠癌患者参加体育锻炼试验很困难，这突出表明需要制定更有效的策略来提高参与率。居家运动方案和有监督的运动方案对接受化疗的结肠癌患者都是安全可行的。有效性需要在更大规模的试验中确定。
荷兰试验注册中心 - NTR2159。
