基于多组分的抗阻运动方案联合蛋白质、维生素 D 和钙补充对接受 ADT 治疗的前列腺癌男性认知功能的影响：一项为期 12 个月的随机对照试验的二次分析。
Effects of a multicomponent resistance-based exercise program with protein, vitamin D and calcium supplementation on cognition in men with prostate cancer treated with ADT: secondary analysis of a 12-month randomised controlled trial.
机构信息
Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Victoria, Australia
Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Victoria, Australia.
出版信息
BMJ Open. 2022 Jun 24;12(6):e060189. doi: 10.1136/bmjopen-2021-060189.
OBJECTIVES
The aim of this preplanned secondary analysis of a 12-month randomised controlled trial was to investigate the effects of a multicomponent exercise programme combined with daily whey protein, calcium and vitamin D supplementation on cognition in men with prostate cancer treated with androgen deprivation therapy (ADT).
DESIGN
12-month, two-arm, randomised controlled trial.
SETTING
University clinical exercise centre.
PARTICIPANTS
70 ADT-treated men were randomised to exercise-training plus supplementation (Ex+ Suppl, n=34) or usual care (control, n=36).
INTERVENTION
Men allocated to Ex + Suppl undertook thrice weekly resistance training with weight-bearing exercise training plus daily whey protein (25 g), calcium (1200 mg) and vitamin D (2000 IU) supplementation.
PRIMARY AND SECONDARY OUTCOME MEASURES
Cognition was assessed at baseline, 6 and 12 months via a computerised battery (CogState), Trail-making test, Rey auditory-verbal learning test and Digit span. Data were analysed with linear mixed models and an intention-to-treat and prespecified per-protocol approach (exercise-training: ≥66%, nutritional supplement: ≥80%).
RESULTS
Sixty (86%) men completed the trial (Ex + Suppl, n=31; control, n=29). Five (7.1%) men were classified as having mild cognitive impairment at baseline. Median (IQR) adherence to the exercise and supplement was 56% (37%-82%) and 91% (66%-97%), respectively. Ex + Suppl had no effect on cognition at any time.
CONCLUSIONS
A 12-month multicomponent exercise training and supplementation intervention had no significant effect on cognition in men treated with ADT for prostate cancer compared with usual care. Exercise training adherence below recommended guidelines does not support cognitive health in men treated with ADT for prostate cancer.
TRIAL REGISTRATION NUMBER
Australian and New Zealand Clinical Trial Registry (ACTRN12614000317695, registered 25/03/2014) and acknowledged under the Therapeutic Goods Administration Clinical Trial Notification Scheme (CT-2015-CTN-03372-1 v1).
目的
本研究对一项为期 12 个月的随机对照试验进行了预先计划的二次分析，旨在探讨联合应用多种成分的运动方案与每日乳清蛋白、钙和维生素 D 补充剂对接受雄激素剥夺治疗（ADT）的前列腺癌男性认知功能的影响。
设计
12 个月、双臂、随机对照试验。
地点
大学临床运动中心。
参与者
70 名接受 ADT 治疗的男性被随机分配至运动训练加补充剂组（Ex+Suppl，n=34）或常规护理组（对照组，n=36）。
干预
分配至 Ex+Suppl 的男性每周进行三次抗阻训练，包括负重运动训练以及每日乳清蛋白（25g）、钙（1200mg）和维生素 D（2000IU）补充剂。
主要和次要结局测量
使用计算机化成套测试（CogState）、连线测验、 Rey 听觉词语学习测验和数字跨度测验，分别在基线、6 个月和 12 个月评估认知功能。使用线性混合模型以及意向治疗和预先指定的方案分析（运动训练：≥66%，营养补充剂：≥80%）。
结果
60 名（86%）男性完成了试验（Ex+Suppl，n=31；对照组，n=29）。5 名（7.1%）男性在基线时被归类为轻度认知障碍。运动和补充剂的中位（IQR）依从率分别为 56%（37%-82%）和 91%（66%-97%）。Ex+Suppl 在任何时间点均对认知功能无影响。
结论
与常规护理相比，12 个月的多成分运动训练和补充干预对接受 ADT 治疗的前列腺癌男性的认知功能没有显著影响。运动训练依从性低于推荐指南并不能支持接受 ADT 治疗的前列腺癌男性的认知健康。
试验注册
澳大利亚和新西兰临床试验注册中心（ACTRN12614000317695，于 2014 年 3 月 25 日注册），并根据治疗商品管理局临床研究通知计划（CT-2015-CTN-03372-1 v1）得到认可。
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