Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital and Institute of Basic Medical Sciences, University of Oslo, Sognsvannsveien 9, 0372, Oslo, Norway.
Department of Health Sciences and Health Policy, University of Lucerne, Frohburgstrasse 3, 6002, Lucerne, Switzerland.
BMC Cancer. 2017 Dec 5;17(1):822. doi: 10.1186/s12885-017-3801-8.
BACKGROUND: Beyond survival of nowadays >80%, modern childhood cancer treatment strives to preserve long-term health and quality of life. However, the majority of today's survivors suffer from short- and long-term adverse effects such as cardiovascular and pulmonary diseases, obesity, osteoporosis, fatigue, depression, and reduced physical fitness and quality of life. Regular exercise can play a major role to mitigate or prevent such late-effects. Despite this, there are no data on the effects of regular exercise in childhood cancer survivors from randomized controlled trials (RCTs). Primary outcome of the current RCT is therefore the effect of a 12-months exercise program on a composite cardiovascular disease risk score in childhood cancer survivors. Secondary outcomes are single cardiovascular disease risk factors, glycaemic control, bone health, body composition, physical fitness, physical activity, quality of life, mental health, fatigue and adverse events (safety). METHODS: A total of 150 childhood cancer survivors aged ≥16 years and diagnosed ≥5 years prior to the study are recruited from Swiss paediatric oncology clinics. Following the baseline assessments patients are randomized 1:1 into an intervention and control group. Thereafter, they are seen at month 3, 6 and 12 for follow-up assessments. The intervention group is asked to add ≥2.5 h of intense physical activity/week, including 30 min of strength building and 2 h of aerobic exercises. In addition, they are told to reduce screen time by 25%. Regular consulting by physiotherapists, individual web-based activity diaries, and pedometer devices are used as motivational tools for the intervention group. The control group is asked to keep their physical activity levels constant. DISCUSSION: The results of this study will show whether a partially supervised exercise intervention can improve cardiovascular disease risk factors, bone health, body composition, physical activity and fitness, fatigue, mental health and quality of life in childhood cancer survivors. If the program will be effective, all relevant information of the SURfit physical activity intervention will be made available to interested clinics that treat and follow-up childhood cancer patients to promote exercise in their patients. TRIAL REGISTRATION: Prospectively registered in clinicaltrials.gov [ NCT02730767 ], registration date: 10.12.2015.
背景：如今，儿童癌症患者的生存率已超过 80%，现代儿童癌症治疗的目标不仅在于延长患者的生存时间，更在于提高患者的长期健康和生活质量。然而，目前大多数癌症幸存者都面临着诸多短期和长期的不良反应，如心血管和肺部疾病、肥胖、骨质疏松、疲劳、抑郁以及身体机能和生活质量下降等问题。定期运动可以起到减轻或预防这些不良反应的作用。尽管如此，目前仍缺乏关于儿童癌症幸存者定期运动效果的随机对照试验（RCT）数据。因此，本 RCT 的主要研究终点为为期 12 个月的运动方案对儿童癌症幸存者复合心血管疾病风险评分的影响。次要研究终点包括单一心血管疾病风险因素、血糖控制、骨健康、身体成分、身体机能、体力活动、生活质量、心理健康、疲劳和不良事件（安全性）。
方法：本研究共纳入了 150 名年龄≥16 岁、确诊癌症≥5 年且来自瑞士儿科肿瘤诊所的儿童癌症幸存者。在基线评估后，患者以 1:1 的比例随机分为干预组和对照组。此后，他们将在第 3、6 和 12 个月进行随访评估。干预组被要求每周增加≥2.5 小时的剧烈运动/周，包括 30 分钟的力量训练和 2 小时的有氧运动。此外，他们还被要求减少 25%的屏幕时间。运动治疗师定期咨询、个人网络活动日记和计步器设备被用作干预组的激励工具。对照组被要求保持其身体活动水平不变。
讨论：本研究的结果将显示部分监督的运动干预是否可以改善儿童癌症幸存者的心血管疾病风险因素、骨健康、身体成分、体力活动和身体机能、疲劳、心理健康和生活质量。如果该方案有效，我们将向有兴趣的、治疗和随访儿童癌症患者的诊所提供 SURfit 身体活动干预的所有相关信息，以促进其患者进行运动。
试验注册：前瞻性注册于 clinicaltrials.gov [NCT02730767]，注册日期：2015 年 12 月 10 日。
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