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HIIT-based Exercise Intervention for Improvement of Immunomodulatory, Cardiopulmonary, and Psychosocial Parameters During Maintenance Therapy of Paediatric Acute Lymphoblastic Leukaemia (HEALL) (HEALL)

2026年11月9日 更新者：University of Erlangen-Nürnberg Medical School

In this study, the investigators aim to examine the effects of high-intensity interval training (HIIT) on cardiopulmonary fitness and immunological recovery in female ALL survivors who underwent cancer treatment during childhood and adolescence.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

108

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

研究联系人备份

学习地点

  • 德国
    • Baveria
      • Erlangen、Baveria、德国、91054
        • University Hospital Erlangen, Department for childhood and adolescence medicine
        • 接触：

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

6年 至 10年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Diagnosed acute lymphatic leukemia
  • Begin of maintenance therapy
  • From 6 to 10 years of age
  • Physical ability to participate in HIIT and cardiopulmonary exercise testing

Exclusion Criteria:

  • Known pleural or pericardial effusion
  • Critical condition (requiring respiratory support, ventilation, oxygen, shock, symptomatic heart failure)
  • Marked thoracic deformities/malformations
  • Previous lung surgery
  • Injuries that do not allow physical stress diagnostics

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
有源比较器：Intervention Group

Total of 6 months of HIIT
行为的：HII-Training (HIIT) 6 Months

HIIT should be done at least 2-3 times per week. Each session's duration is 60 minutes including warm-up and cool-down. Study participation will be monitored.

诊断测试：Cardiopulmonary exercise testing

Treadmill Exercising Test

诊断测试：Echocardiography

Echocardiography with strain rate imaging

诊断测试：Electrocardiography (EKG)

Routine Electrocardiography

诊断测试：blood draw

Comprehensive fluorescence activated cell sorting (FACS) systematically assessing immune reconstitution of T-, B-, and NK cells after termination of intensive chemotherapy (5ml)

诊断测试：Questionnaire

QoL: Kid-KINDL

诊断测试：MSOT

Multispectral-optoacustic imaging of the calf muscle
有源比较器：Control Group

3 months without intervention followed by 3 months of HIIT
诊断测试：Cardiopulmonary exercise testing

Treadmill Exercising Test

诊断测试：Echocardiography

Echocardiography with strain rate imaging

诊断测试：Electrocardiography (EKG)

Routine Electrocardiography

诊断测试：blood draw

Comprehensive fluorescence activated cell sorting (FACS) systematically assessing immune reconstitution of T-, B-, and NK cells after termination of intensive chemotherapy (5ml)

诊断测试：Questionnaire

QoL: Kid-KINDL

诊断测试：MSOT

Multispectral-optoacustic imaging of the calf muscle

行为的：HIT-Training (HIIT) 3 Months

HIIT should be done at least 2-3 times per week. Each session's duration is 60 minutes including warm-up and cool-down. Study participation will be monitored.

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
VO2
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

Oxygen uptake (VO2)
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
VO2max
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

peak oxygen uptake (VO2max)
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
RER
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

Respiratory exchange ratio (RER)
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
VT2
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

Ventilatory anaerobic threshold (VT2)
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
VCO2
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

Carbon dioxide output (VCO2)
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
HR
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

Heart rate (HR)
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
HRR
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

Heart Rate Reserve (HRR)
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
Breath rate at VAT
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

Breath rate at VAT
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
BRR
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

Breath rate reserve (BRR)
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
VE
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

minute ventilation (VE)
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
O2 Pulse
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

O2 Pulse
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
HRV
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

Heart rate variability (HRV)
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
Echocardiography
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

Myocardial function by echocardiographic strain and strain-rate imaging
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
Age
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

Age in years
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
Gender
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

Gender
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
Weight
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

Weight
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
Blood pressure
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

Blood pressure measurement
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
QoL
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

Quality of Life: Kid-KINDL
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
Immune reconstitution (IR)
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

T-, B- and natural killer cell count and marker expression profiles in FACS Blood sample (5ml)
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
Oxygenated haemoglobin (HbO₂, MSOT)
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

Oxygenated haemoglobin (HbO₂)
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
Deoxygenated haemoglobin (HHb, MSOT)
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

Deoxygenated haemoglobin (HHb)
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
Total haemoglobin (tHb, MSOT)
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

Total haemoglobin (tHb)
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
Tissue oxygen saturation (sO₂, MSOT)
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

Tissue oxygen saturation (sO₂)
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
Signal Intensity (SI, MSOT)
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

MSOT signal intensity per region of interest
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization
MSOT topogram of perfusion of the m. gastrocnemius
大体时间：3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

MSOT topogram of perfusion of the m. gastrocnemius
3 Time points: First evaluation: Before Randomization Second evaluation: 3 months after randomization Third evaluation: 6 months since after randomization

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。

赞助

University of Erlangen-Nürnberg Medical School

合作者

Bavarian Cancer Research Center (BZKF)

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 (估计的)

2027年1月1日

初级完成 (估计的)

2028年7月1日

研究完成 (估计的)

2029年1月1日

研究注册日期

首次提交

2026年10月29日

首先提交符合 QC 标准的

2026年11月9日

首次发布 (实际的)

2026年11月13日

研究记录更新

最后更新发布 (实际的)

2026年11月13日

上次提交的符合 QC 标准的更新

2026年11月9日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HEALL
  • TPRÄ_25_3_E_KARO (其他赠款/资助编号：Bavarian Cancer Research Center (BZKF))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The raw, individual and identifiable patient data are protected and are not available due to data privacy laws. Further data sets are planned to be shared

IPD 共享时间框架

Beginning 9 months and ending 36 months following article publication

IPD 共享访问标准

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request as follows:

Individual participant data will not be available Study Protocol and Statistical Analysis Plan will be available The data will be available beginning 9 months and ending 36 months following article publication.

The data will be available to researchers who provide a methodologically sound proposal.

The data will be available for individual participant data meta-analysis, only. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at https://www.uk-erlangen.de.

Restrictions may apply due to patient privacy and the General Data Protection Regulation.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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