重新获得能量的锻炼(能量研究)
2023年12月1日 更新者:University of Florida
以中心为基础和以家庭为基础的步行锻炼干预,以减少老年乳腺癌幸存者的疲劳
大约 20%-70% 的乳腺癌幸存者在癌症治疗后会感到疲劳。
由于流行病学证据表明,高龄是有癌症病史的成年人疲劳的一个危险因素,因此年长的乳腺癌幸存者比年轻的幸存者更容易感到疲劳。
本研究的目的是测试步行运动干预的类型及其减轻老年乳腺癌幸存者疲劳的能力。
研究概览
详细说明
患有乳腺癌的女性在癌症治疗后经常会出现严重的疲劳(乏力),大约 40% 的乳腺癌幸存者会出现这种情况。 由于年龄较大是疲劳的一个危险因素,因此与较年轻的年龄组相比,年龄较大的乳腺癌幸存者的风险更高。 先前的证据表明,有氧运动可以减少炎症和生物能量生成障碍,这些都是导致疲劳发病机制的关键因素。 尽管介入性研究表明有氧运动可以改善年轻乳腺癌幸存者的疲劳,但有氧运动的抗疲劳作用往往会随着年龄的增长而降低。 研究人员假设,新的干预措施与有氧运动相结合可以提高其有效性并进一步减轻老年乳腺癌幸存者的严重疲劳。
在这项试点 RCT 中,研究人员将招募 24 名年龄≥60 岁的女性癌症幸存者,她们被诊断患有浸润性乳腺癌,但已完成至少 3 个月但不超过 1 年的辅助治疗。 参与者将被随机分配到以中心为基础的步行锻炼干预或以家庭为基础的步行锻炼干预,为期 8 周。 通过完成这项试点研究,研究人员将能够收集初步数据;完善我们的招聘、衡量、随机化和保留策略;并针对潜在的全面 RCT 调整我们的统计策略和时间表。
研究类型
介入性
注册 (估计的)
24
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Florida
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Gainesville、Florida、美国、32611
- 招聘中
- Institute on Aging; University of Florida
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接触:
- Stephen D Anton, PhD
- 电话号码:352-273-7514
- 邮箱:santon@ufl.edu
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首席研究员:
- Stephen D Anton, PhD
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
60年 至 105年 (成人、年长者)
接受健康志愿者
不
描述
纳入标准:
- 同意参与研究
- 年龄≥60岁
- 患有 I-III 期浸润性乳腺癌
- 癌症在 2021 年或 2022 年确诊
- 完成至少 3 个月但不超过 1 年的辅助治疗
- 愿意参与所有研究程序
- 至少有中度疲劳(定义为 PROMIS 测量的原始分数 ≥ 8)
排除标准:
- 未能提供知情同意
- 目前参与康复计划
- 运动训练的绝对禁忌症
- 显着认知障碍
- 进行性退行性神经系统疾病
- 过去 4 个月内发生髋部骨折、髋部或膝部置换术或脊柱手术
- 可能损害参与运动干预能力的其他重大合并症
- 孕
- 经常食用烟酰胺核苷补充剂
- 同时参与其他介入研究
- 没有或非常轻微的疲劳(在 PROMIS 中定义为原始分数≤7)
- 在过去三年内诊断出以下任何一种疾病(冠心病、心绞痛、心脏病发作、心力衰竭、中风、高血压、慢性阻塞性肺病、慢性支气管炎、关节炎、糖尿病和慢性肾病),由行为风险因素监测系统衡量
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:以中心为基础的步行锻炼
在研究期间,受试者将被随机分配接受每周 3 天的基于中心的步行锻炼干预。
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每次锻炼都将以短暂的热身开始,然后进行 30 分钟的步行。
最初将指示参与者以中等强度行走,相当于 Borg 类别比 (CR) 量表的 5-6。
如果可能,将鼓励参与者进行短时间的剧烈步行(CR10 量表为 7-8 分钟),目标是每节至少进行 10 分钟的剧烈步行。
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实验性的:居家步行锻炼
受试者将被随机分配到他们的社区步行锻炼五天/周。
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参与者将被要求每周在他们的社区步行锻炼五天。
将指导参与者在干预的第一个月开始进行 10-15 分钟的步行锻炼/会话,然后每周将锻炼持续时间增加 5 分钟/会话,以促进合理但稳定地朝着每次会话 30 分钟的目标迈进。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
自我报告的疲劳
大体时间:至第 8 周的基线
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患者报告结果测量信息系统 (PROMIS) 是一套以人为本的测量方法,根据专家对反映总体健康状况、功能状态和生活质量的项目的审查,评估和监测身体、心理和社会健康。
所有项目均基于 5 点量表(1=从不;2=很少;3=有时;4=经常;5=总是)和 PROMIS 反向评分项目 7 进行测量。所有项目的分数相加,分数较高表示比较疲劳。
原始总分将从 7 分到 35 分不等。
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至第 8 周的基线
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
精神困扰(抑郁和焦虑)
大体时间:至第 8 周的基线
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过去 7 天的精神困扰(抑郁和焦虑)将通过 PROMIS 进行测量。
参与者将分别回答8个和7个问题来反映抑郁和焦虑的严重程度;对于每个问题,将采用 5 分制和归一化 T 分数作为疲劳程度的衡量标准。
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至第 8 周的基线
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自我报告的疼痛
大体时间:至第 8 周的基线
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过去 7 天的自我报告疼痛将通过 PROMIS 疼痛干扰简表中的 6 个问题来衡量;这些问题测量疼痛的严重程度并使用 5 分制(1=完全没有;2=有点;3=有点;4=相当多;5=非常多),其总和可以转换为标准化 T -分数。
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至第 8 周的基线
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自我报告的睡眠障碍
大体时间:至第 8 周的基线
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自我报告的睡眠简表 (8a),用于评估 18 岁及以上人群睡眠障碍的纯域。
测量中的每个项目都采用 5 分制评分(1 = 非常好;2 = 好;3 = 一般;4 = 差;5 = 非常差),分数范围从 8 到 40,分数越高表明更严重的睡眠障碍,其总和可以转化为标准化的 T 分数。
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至第 8 周的基线
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步态速度
大体时间:至第 8 周的基线
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步态速度将通过 6 分钟步行测试进行评估,该测试衡量参与者在标准步行课程中可以在六分钟内完成的距离量,而无需跑步或过度用力。
步速将通过国家健康和营养检查调查中使用的方法进行测量;参与者将被要求完成 20 英尺的步行测试,步态速度将计算为 (20×0.3048
米)/(完成测试的时间(秒))。
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至第 8 周的基线
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身体机能
大体时间:至第 8 周的基线
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身体机能将通过短期身体机能成套测试 (SPPB) 进行评估。
该电池评估不同任务的功能表现,包括定时短距离步行、重复椅子站立和平衡测试。
此外,将使用手持式测力计评估等距握力,这是一种常用的上肢骨骼功能测量方法。
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至第 8 周的基线
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治疗诱发的周围神经病变 (TIPN)
大体时间:至第 8 周的基线
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10 项治疗诱发的神经病变评估量表 (TNAS) 将用于评估周围神经病变的严重程度和对基线时以及化疗后或化疗后日常功能的影响。
所有项目均基于 10 分制进行衡量。
所有项目的分数相加,分数越高表示神经病变越严重。
将计算两个分量表分数以评估与感觉或干扰维度相关的症状。
感官分量表得分将是 6 个感官项目的平均值:麻木、刺痛、疼痛、灼热或灼热感、寒冷感和睡眠不安。
干扰子量表得分 - 3 个干扰项目的平均值:行走困难、平衡困难和用手困难。
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至第 8 周的基线
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癌症治疗的功能评估 - 乳房 (FACT-B)
大体时间:至第 8 周的基线
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FACT-B 是一个包含 37 个项目的工具,旨在测量乳腺癌幸存者 HRQOL 的五个领域:身体、社会、情感、功能健康以及乳腺癌分量表 (BCS)。
测量中的每个项目都采用 5 点李克特式量表进行评分(完全没有;有一点;有点;有一点;非常多)。
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至第 8 周的基线
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感知压力
大体时间:至第 8 周的基线
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感知压力量表 (PSS-10) 涵盖感受和当前生活状况,两者均采用 5 点李克特量表(0 = 从不,1 = 几乎从不,2 = 有时,3 = 经常,4 = 非常经常);较高的分数表示较高的感知压力。
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至第 8 周的基线
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性格感恩
大体时间:至第 8 周的基线
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Gratitude Questionnaire-6 (GQ-6) 旨在衡量性格感恩的四个方面:(a) 强度,(b) 频率,(c) 跨度和 (d) 密度。
每个项目都采用 7 点李克特量表进行评分,范围从 1(非常不同意)到 7(非常同意)。
分数范围从 6 到 42,分数越高表示感恩倾向越高,分数越低表示感恩倾向越低。
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至第 8 周的基线
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习惯性体力活动
大体时间:至第 8 周的基线
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自我管理问卷,通过三个组成部分评估习惯性身体活动:工作活动、体育活动和休闲活动。
改良的 Baecke 问卷测量老年人的习惯性活动,其中包括有关家庭活动、体育和休闲活动的问题。
将使用 Apple Watch 测量基线和后续的自由生活身体活动。
将根据四个标准衡量步行锻炼干预的依从性:总步行分钟数、指定目标心率区内的总步行分钟数、每周完成的规定步行分钟数百分比以及每周目标心率区内规定步行分钟数的百分比.
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至第 8 周的基线
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Stephen Anton、University of Florida
出版物和有用的链接
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2023年11月29日
初级完成 (估计的)
2025年8月1日
研究完成 (估计的)
2025年8月1日
研究注册日期
首次提交
2022年8月23日
首先提交符合 QC 标准的
2023年1月12日
首次发布 (实际的)
2023年1月13日
研究记录更新
最后更新发布 (估计的)
2023年12月8日
上次提交的符合 QC 标准的更新
2023年12月1日
最后验证
2023年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.