Physical Exercise Therapy vs Relaxation in Allogeneic Stem Cell Transplantation (PETRA) (PETRA)
2019年12月20日 更新者：German Cancer Research Center
Effects of an One-year Physical Exercise Intervention on Prognosis, Side-effects and Complications After Allogeneic Stem Cell Transplantation
The PETRA-Study is a randomized, controlled trial and designed to examine the effects of an one-year physical exercise intervention on prognosis, side-effects and complications after allogeneic stem cell transplantation.
The exercise intervention includes both, resistance and endurance training. Patients assigned to the control group perform a relaxation program (progressive muscle relaxation - Jacobsen) and have the same frequency of social contact.
研究概览
研究类型
介入性
注册 (实际的)
267
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
-
-
-
Heidleberg、德国、69120
- German Cancer Research Center
-
-
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
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Medical indication: allogeneic stem cell transplantation
Exclusion Criteria:
- Orthopeadic limitations that hamper the exercise intervention
- Osseous degenerations that have an improved fracture risk
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：支持治疗
- 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 |
|---|---|
|
实验性的：resistance and endurance exercise
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resistance and endurance exercise, 3-5 times per week
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|
有源比较器：relaxation
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resistance and endurance exercise, 3-5 times per week
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
总生存期
大体时间：两年
|
两年
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fatigue
大体时间：admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation
|
measured by the Multidimensional Fatique Inventory (MFI)
|
admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation
|
|
Quality of Life
大体时间：admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation
|
mesured by the European Organistion for Research and Treatment of Cancer questionnaire including the high dose chemotherapy module (EORTC-QLQ-C30/HDC-29)
|
admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation
|
|
Hemoglobin, Leukocytes, Thrombocytes
大体时间：during hospitalisation for allo-HSCT (expected average 4-5 weeks), day 100, day 180, day 270, day 365 post transplantation
|
Hematological and immunological reconstitution
|
during hospitalisation for allo-HSCT (expected average 4-5 weeks), day 100, day 180, day 270, day 365 post transplantation
|
|
Side-effects (Infections, GvHD, Depression, Distress)
大体时间：during hospitalisation for allo-HSCT (expected average 4-5 weeks), day 100, day 180, day 270, day 365 post transplantation
|
Depression mesured by "Allgemeine Depressionskala" (ADS, the German version of the Center for Epidemiological Studies Depression Scale (CES-D)) Distress mesures by the NCCN Distress Thermometer
|
during hospitalisation for allo-HSCT (expected average 4-5 weeks), day 100, day 180, day 270, day 365 post transplantation
|
|
Adherence to exercise protocol
大体时间：one year
|
Fesability of an one-year exercise intervention after allogeneic HSCT
|
one year
|
|
Muscular strength
大体时间：admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation
|
measured at the IsoMed2000 and/or Handheld Dynamometer
|
admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation
|
|
cardiorespiratory fitness
大体时间：admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation
|
measured by ergospirometry (VO2max) and/or 6 Minutes Walk Test (meters)
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admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation
|
|
IL-6, IL-4, IL-8, IL-10, IL-1ra, TNF-alpha, Prostaglandin
大体时间：admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation
|
Biomarker in blood and urine
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admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation
|
|
median survival, non-relapse mortality
大体时间：admission to hospital until 2 years after transplantation
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admission to hospital until 2 years after transplantation
|
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。
合作者
调查人员
- 首席研究员：Joachim Wiskemann, PhD、National Center for Tumor Diseases
- 首席研究员：Martin Bohus, Prof. MD、Central Institute of Mental Health
- 学习椅：Dreger Peter, Prof. MD、University Hospital Heidelberg
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
- Aziz JA, Smith C, Slobodian M, Du I, Shorr R, De Lisio M, Allan DS. Impact of Exercise Training on Hematological Outcomes Following Hematopoietic Cell Transplantation: A Scoping Review. Clin Invest Med. 2021 Jun 14;44(2):E19-26. doi: 10.25011/cim.v44i2.36369.
- Wiskemann J, Kuehl R, Dreger P, Huber G, Kleindienst N, Ulrich CM, Bohus M. Physical Exercise Training versus Relaxation in Allogeneic stem cell transplantation (PETRA Study) - Rationale and design of a randomized trial to evaluate a yearlong exercise intervention on overall survival and side-effects after allogeneic stem cell transplantation. BMC Cancer. 2015 Sep 7;15:619. doi: 10.1186/s12885-015-1631-0.
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)
2011年2月1日
初级完成 (实际的)
2019年7月1日
研究完成 (实际的)
2019年7月1日
研究注册日期
首次提交
2011年4月18日
首先提交符合 QC 标准的
2011年6月15日
首次发布 (估计)
2011年6月16日
研究记录更新
最后更新发布 (实际的)
2019年12月24日
上次提交的符合 QC 标准的更新
2019年12月20日
最后验证
2019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.