饮食失调对急性运动的反应
2024年3月19日 更新者:University of Wisconsin, Madison
限制性饮食失调的急性运动反应特征
饮食失调 (ED) 患者是临床重点关注的人群,其死亡率是所有精神疾病中最高的,而高达 80% 的 ED 患者中,强迫运动 (DEx) 是一种症状,会增加损害并产生负面影响影响治疗效果。
这项研究将开发任务来描述患有 ED 的青少年和年轻成年女性对运动的认知、情感和生物反应,并确定急性运动反应是否与自由生活活动和 DEx 相关。
该 R21 项目将提供基础数据,以指导更精确地针对强迫运动症状的治疗方法的研究和开发,并最终改善与 ED 相关的临床结果。
研究概览
详细说明
饮食失调(ED)是所有精神疾病中最致命的一种。
然而,ED 的一线治疗仅对大约 40% 的青少年患者有效。
影响治疗效果的一个障碍是持续进行驱动性运动(DEx;以强迫性方式进行运动以控制体重和/或调节情绪),这是许多诊断为限制性 ED 的青少年 (59-73%) 中报告的一种标志性症状。
在其他负面后遗症中,DEx 与自杀行为、较差的治疗结果、共病精神病理学增加以及复发风险有关。
此外,虽然多项与饮食相关的任务已被验证可以区分 ED 患者和健康人群,但目前还没有经过充分验证的任务可以直接评估 ED 人群对运动的敏感性和反应性。
由于 DEx 是一种人们知之甚少的症状,但它在 ED 维持中发挥着关键作用,因此研究其生物行为基础至关重要。
现有的研究指出运动的奖励和威胁功能,这可能会推动并维持 ED 患者的 DEx。
对 ED 患者运动的奖励函数和威胁函数进行评估将提高对 ED 特征的机制理解;最终,加深对 DEx 的了解将为治疗目标提供信息。
拟议项目将从两个地点招募有(n = 67)和没有(n = 33)ED 的青少年和年轻成年女性(16-22 岁)参与急性运动反应的综合评估。
当前的项目将 1) 描述患有和未患有 ED 的人对实验室内中等强度运动的生物行为反应的变异性; 2)创建和完善任务,捕捉演习期间奖励和威胁相关系统的参与情况; 3) 测试假设,即急性运动反应在 ED 患者中更为明显,并且急性运动反应与 ED 症状严重程度、DEx 和自由生活活动有关。
在受控环境中详细解释 ED 患者的急性运动效应将对 ED 的实证研究产生重大影响,特别是 (i) 改进 DEx 风险和功能的评估 (ii) 阐明 DEx 风险的可测试模型以及 (iii) )建议 DEx 干预的目标。
该项目中验证的方法将增进对 DEx(一种难治性 ED 特征)的理解。
这些方法还将为更大规模的临床研究奠定基础,从而阐明 DEx 在 ED 治疗中的最佳目标。
研究类型
介入性
注册 (估计的)
100
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。
学习联系方式
- 姓名:Katherine Schaumberg, PhD
- 电话号码:919-244-9415
- 邮箱:kschaumberg@wisc.edu
研究联系人备份
- 姓名:Sasha Gorrell, PhD
- 邮箱:Sasha.Gorrell@ucsf.edu
学习地点
-
-
California
-
San Francisco、California、美国、94158
- 招聘中
- University of California San Francisco
-
接触:
- Sasha Gorrell, PhD
- 电话号码:917-685-5436
- 邮箱:Sasha.Gorrell@ucsf.edu
-
首席研究员:
- Sasha Gorrell, PhD
-
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Wisconsin
-
Madison、Wisconsin、美国、53719
- 招聘中
- University of Wisconsin-Madison
-
接触:
- Katherine Schaumberg, PhD
- 电话号码:919-244-9415
- 邮箱:kschaumberg@wisc.edu
-
首席研究员:
- Katherine Schaumberg, PhD
-
-
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
- 孩子
- 成人
接受健康志愿者
是的
描述
纳入标准:
- 16-22岁
- ED 参与者必须符合 DSM-5 限制性饮食失调的全部标准,其特征是体重和体形问题,即神经性厌食症 (AN);轻度、中度或部分缓解)、非典型 AN 和仅限 OSFED -AN 型)
- 急诊科参与者必须身体状况稳定,并且适合门诊治疗
- 生物学上的女性,出生时指定为女性
- 英语会话
排除标准:
患有无法运动的健康状况(例如严重哮喘)的人将因任何禁忌症而被排除在外
- 生物学上的男性,出生时指定为男性
- BMI 低于 16(18 岁以上)或低于预期体重的 75%(18 岁以下)
- 饮食失调检查报告摄入量每日<1000kcal
- 当前清除 >1x 每天
- 当前客观暴食的定期发作(> 1 次/周)
- 目前根据饮食失调检查访谈自我报告的饮食失控情况
- 过去一个月因 ED 相关住院、部分住院或住院治疗
- 任何经认可的与身体活动相关的医疗问题(如有关心血管、肺部或代谢疾病的电话筛查问题中所探讨的)。
- 重大疾病(例如癌症、艾滋病)
- 身体不适或抽血困难
- 精神障碍
- 智力障碍
- 发育障碍
- 活性物质使用障碍
- 根据自杀筛查问卷当前的自杀风险
- 怀孕
- 至少 4 周不稳定的精神科药物
- 实验室会议前一整天不允许使用急性镇静剂/止痛药(例如苯二氮卓类药物、阿片类药物)和处方兴奋剂(例如哌醋甲酯、安非他明)。 上述短期药物保留仅适用于在用于治疗多动症或其他精神疾病的情况下服用上述药物的受试者
- 静息心率 <50 次/分钟(筛选访视时评估)
- 低血压 (<90/60),(在筛选访视时评估)
- 每日吸食大麻
- 抽血或体力活动期间有头晕或昏厥史
- 体力活动时有胸痛史
- 骨骼、关节、心脏、肺部、代谢或其他可能因体力活动而恶化的医疗状况(例如慢性阻塞性肺病、糖尿病、高血压),目前无法通过药物或生活方式的改变来解决。
- 妨碍任务执行的身体残疾(例如失明或耳聋)
- 研究者认为可能使参与者面临负面结果风险的任何其他情况
- 患有限制性饮食失调症的个体,不包括体重和体形问题 (ARFID) 或有原发性暴食症 (神经性贪食症)
- 身体活动准备问卷中与运动相关的健康风险指示
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:其他
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:对运动和休息的反应
研究参与者在 3 个研究日内接受规定的锻炼、自定进度的锻炼和休息条件
|
将全面检查 ED 严重程度、体力活动反应的生物和情感标记,以及与体力活动相关的运动特异性和一般正(奖励)和负(回避/逃避)效价敏感性。
|
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 |
---|---|---|
对实验室锻炼的反应 - 身体形象
大体时间:在 30 分钟的活动中每 5 分钟一次。除了学习日本身之外,没有任何后续行动。
|
身体形象状态量表有 6 个项目,要求参与者以 9 点李克特量表报告他们的瞬时身体满意度。
每个项目都以“现在,我感觉”这句话开头[例如:“现在,我对我的外表感到(非常不满意到非常满意)”]
|
在 30 分钟的活动中每 5 分钟一次。除了学习日本身之外,没有任何后续行动。
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对实验室练习的反应 - 影响
大体时间:在 30 分钟的活动中每 5 分钟一次。除了学习日本身之外,没有任何后续行动。
|
参与者在锻炼期间每 5 分钟自我报告一次身体活动影响量表 (PAAS) 中代表最高负荷的项目。
这些项目包括感觉“糟糕”、“热情”、“疲劳”和“平静”。
参与者使用 5 分制对每个项目进行评分(0=没有感觉 -4=感觉非常强烈)。
|
在 30 分钟的活动中每 5 分钟一次。除了学习日本身之外,没有任何后续行动。
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对实验室锻炼的反应 - 生物标志物
大体时间:运动前(基线)、运动后(30 分钟)、休息前(基线)、休息后(30 分钟)。除了学习日本身之外,没有任何后续行动。
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将通过运动和休息前后采集的血液样本收集生物标志物,并通过酶联免疫吸附测定 (ELISA) 试剂盒进行测量: 循环瘦素(瘦素免疫测定) 循环内源性大麻素(2-花生四烯酰甘油 (2-AG) 和 2-油酰甘油 (2-OG) 血浆免疫测定) 循环脑源性神经营养因子(BDNF 免疫测定) 循环皮质醇(皮质醇免疫测定) |
运动前(基线)、运动后(30 分钟)、休息前(基线)、休息后(30 分钟)。除了学习日本身之外,没有任何后续行动。
|
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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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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2日
初级完成 (估计的)
2025年7月31日
研究完成 (估计的)
2025年7月31日
研究注册日期
首次提交
2024年1月9日
首先提交符合 QC 标准的
2024年1月18日
首次发布 (实际的)
2024年1月19日
研究记录更新
最后更新发布 (实际的)
2024年3月20日
上次提交的符合 QC 标准的更新
2024年3月19日
最后验证
2024年3月1日
更多信息
与本研究相关的术语
其他研究编号
- 2019-1585
- 1R21MH131787-01A1 (美国 NIH 拨款/合同)
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计划共享个人参与者数据 (IPD)?
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研究结论时
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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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