Protocol for GET FIT Prostate: a randomized, controlled trial of group exercise training for fall prevention and functional improvements during and after treatment for prostate cancer.
Protocol for GET FIT Prostate: a randomized, controlled trial of group exercise training for fall prevention and functional improvements during and after treatment for prostate cancer.
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DOI：
10.1186/s13063-021-05687-7
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发表时间：
2021-11-06
期刊：
影响因子：
2.5
通讯作者：
Beer TM
中科院分区：
文献类型：
--
作者：
Winters-Stone KM;Li F;Horak F;Dieckmann N;Hung A;Amling C;Beer TM
许多前列腺癌幸存者接受雄激素剥夺治疗（ADT），但这些治疗可能会增加虚弱，恶化身体功能，并增加跌倒风险。虽然运动可以对抗与ADT相关的功能下降，但没有研究测试是否以及哪种类型的运动可以减少福尔斯和虚弱。本试验的目的是比较力量训练与太极拳训练对暴露于ADT治疗前列腺癌的男性的福尔斯跌倒、虚弱和身体功能的相对有效性。接受ADT治疗的前列腺癌幸存者（N = 360）在过去一年中跌倒或根据经验证的风险因素有跌倒风险，将招募这些患者参加这项单盲、平行组、随机试验。受试者将被随机分配到三个有监督的团体训练计划之一：（i）力量训练，（ii）太极拳训练，或（iii）拉伸（对照），每周训练3次，持续6个月。在基线、3个月（干预中期）、6个月（干预后即刻）和12个月（随访）时评估结局。主要结局是通过每月自我报告评估的福尔斯。次要结局包括：虚弱（低瘦体重（通过生物电阻抗分析）、疲惫（通过SF-36活力量表）、低活动（通过CHAMPS体力活动调查）、缓慢（通过4 m通常步行速度）和虚弱（通过椅子站立时间））;还将收集身体功能的客观和主观指标。将使用负二项回归模型评估组间福尔斯的差异，而混合效应模型将用于比较训练组对次要结局的相对疗效。运动是缓解ADT治疗男性中发生的福尔斯问题的非药物方法。通过适当的锻炼，男性可以避免或延迟与癌症治疗相关的福尔斯、虚弱和残疾。该试验的结果预计将告知临床实践如何将运动作为ADT处方的前列腺癌幸存者癌症护理的一部分。ClinicalTrials.gov NCT 03741335。于2018年11月18日注册。在线版本包含补充材料，可通过10.1186/s13063-021-05687-7获得。
Many prostate cancer survivors are treated with androgen deprivation therapy (ADT), but these therapies may increase frailty, worsen physical functioning, and increase fall risk. While exercise may counter functional declines associated with ADT, no studies have tested whether and which type of exercise may reduce falls and frailty. The purpose of this trial is to compare the relative efficacy of strength training versus tai ji quan training against each other and to a stretching control group on falls, frailty, and physical functioning in men expose to ADT for prostate cancer. Prostate cancer survivors treated with ADT (N = 360) who have fallen in the past year or are at risk of a fall based on validated risk factors will be recruited to participate in this single-blind, parallel group, randomized trial. Participants will be randomized to one of three supervised, group training programs: (i) strength training, (ii) tai ji quan training, or (iii) stretching (control), that train 3×/week for 6 months. Outcomes are assessed at baseline, 3 (mid-intervention), 6 (immediately post-intervention), and 12 (follow-up) months. The primary outcome is falls assessed by monthly self-report. Secondary outcomes include the following: frailty (low lean body mass (by bioelectrical impedance analysis), exhaustion (by SF-36 vitality scale), low activity (by CHAMPS physical activity survey), slowness (by 4 m usual walk speed), and weakness (by chair stand time)); objective and subjective measures of physical function will also be collected. Negative binomial regression models will be used to assess differences in falls between groups, while mixed effects modeling will be used to compare the relative efficacy of training group on secondary outcomes. Exercise represents a non-pharmacologic approach to mitigate the problem of falls experienced among men treated with ADT. By engaging in appropriate exercise, men may be able to avoid or delay falls, frailty, and disability associated with their cancer treatment. Findings of the trial are expected to inform clinical practice about how exercise could be prescribed as part of cancer care for prostate cancer survivors prescribed ADT. ClinicalTrials.gov NCT03741335. Registered on November 18, 2018. The online version contains supplementary material available at 10.1186/s13063-021-05687-7.
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影响因子：
1.9
作者：
Bennett JA;Winters-Stone KM;Dobek J;Nail LM
通讯作者：
Nail LM
影响因子：
3.1
作者：
Cella, David;Lai, Jin-Shei;Stone, Arthur
通讯作者：
Stone, Arthur
接受雄激素剥夺疗法的前列腺癌生化复发老年男性的肥胖、体能缺陷和跌倒： 病例对照研究
影响因子：
2.1
作者：
Bylow, Kathryn;Hemmerich, Joshua;Dale, William
通讯作者：
Dale, William
影响因子：
5
作者：
Chan, Benjamin K. S.;Marshall, Lynn M.;Orwoll, Eric S.
通讯作者：
Orwoll, Eric S.
影响因子：
7.2
作者：
Groll, DL;To, T;Wright, JG
通讯作者：
Wright, JG