Consequences of Eccentric Cycling on Exercise-related Neuromuscular Responses and Biomarkers in Breast Cancer Patients (PROTECT-05)
2022年5月25日 更新者：Institut de cancérologie Strasbourg Europe
This is a monocentric, prospective and interventional study aimed to investigating the physiological responses of eccentric compared to concentric cycling realized 1) at the same metabolic demand and 2) at the same mechanical power output. In order to compare the physiological responses between these two cycling modalities, 3 cycling sessions should be performed for each patient where concentric one will serve as reference / comparison to the eccentric one:
- Session (a): eccentric cycling
- Session (b): high intensity concentric cycling realized at the same mechanical power output than eccentric cycling
- Session (c): low intensity concentric cycling realized at the same metabolic demand than eccentric cycling The 3 sessions will be performed for each patient and order will be randomized.
研究概览
详细说明
For each participant, 10 visits will be realized as followed:
Visit 1: determination of maximal O2 consumption (VO2max) and first familiarization session to eccentric cycling Visits 2, 3 and 4: second, third and fourth eccentric cycling familiarization sessions Visits 5, 7 and 9: cycling sessions (a), (b) and (c) attributed in a random order Visits 6, 8 and 10: post-24h measurements after cycling sessions
研究类型
介入性
注册 (实际的)
12
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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Strasbourg、法国
- Institut de cancerologie Strasbourg Europe
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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
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
女性
描述
Inclusion Criteria:
- Woman who completed (neo)adjuvant chemotherapy since less than 1 year for a breast cancer
- Woman under hormonotherapy, or menopausal woman, or woman in amenorrhea
Exclusion Criteria:
- Pregnant and nursing woman
- psychiatric, musculoskeletal or neurological disorders
- presenting at least one contraindication to the use of the transcranial magnetic stimulation
- presenting at least one contraindication to the realisation of the maximum effort test
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：基础科学
- 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 |
|---|---|
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实验性的：eccentric cycling compared to concentric cycling
Every participant will perform the same protocol and will participated to the 3 experimental sessions (a, b and c) of the assigned intervention.
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Eccentric cycling
High intensity concentric cycling realized at the same mechanical power output than eccentric cycling
Low intensity concentric cycling realized at the same metabolic demand than eccentric cycling
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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 |
|---|---|---|
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Investigate the physiological responses of the eccentric cycling on the knee extensors muscles by changes of neuromuscular parameters
大体时间：24 hours after pedaling sessions
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Measurement of neuromuscular fatigue via change in maximal voluntary isometric contraction of the knee extensors muscles registered via a force sensor.
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24 hours after pedaling sessions
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Comparison of muscle pain after eccentric in session (a) and after concentric modalities in session (b) and session (c)
大体时间：24 hours after pedaling sessions
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Measurement of muscle pain by visual analog scale (VAS) consists of a 100 mm long line providing a range of score from 0-100 (0: no pain, 100: worst possible pain).
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24 hours after pedaling sessions
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Comparison of central (identified as a decrease in voluntary activation, VA) fatigue after eccentric in session (a) and after concentric modalities in session (b) and session (c)
大体时间：24 hours after pedaling sessions
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Measurement of central fatigue by percutaneous neurostimulation applied during the maximal voluntary contraction to evidence the level of voluntary activation (VA in %) and by transcranial magnetic stimulation to evidenced level of corticospinal excitability (measured by the MEP visible on EMG activity).
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24 hours after pedaling sessions
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Comparison of peripheral (identified as a decrease in the quadriceps twitch muscle contractile capacities, Qtw) fatigue after eccentric in session (a) and after concentric modalities in session (b) and session (c)
大体时间：24 hours after pedaling sessions
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Measurement of peripheral fatigue by percutaneous neurostimulation applied at rest to evoked quadriceps twitch force (Qtw) to evidence muscle contractile properties.
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24 hours after pedaling sessions
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Comparison of muscle thickness measured via ultrasonography on the vastus lateralis muscle after eccentric modality in pedaling session (a) and after concentric modalities in pedaling sessions (b) and (c)
大体时间：24 hours after pedaling sessions
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Change from baseline by ultrasonography measurements in the muscle thickness of the vastus lateralis muscle.
Muscle thickness was measured as the distance from the superior border of the superficial aponeurosis and the superior border of the deep aponeurosis.
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24 hours after pedaling sessions
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Comparison of muscle fibers pennation angle measured via ultrasonography on the vastus lateralis muscle after eccentric modality in pedaling session (a) and after concentric modalities in pedaling sessions (b) and (c)
大体时间：24 hours after pedaling sessions
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Change from baseline by ultrasonography measurements in the pennation angle of the vastus lateralis muscle.
Pennation angle was measured as the angle between a fiber and the deep aponeurosis.
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24 hours after pedaling sessions
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Comparison of muscle fibers fascile length measured via ultrasonography on the vastus lateralis muscle after eccentric modality in pedaling session (a) and after concentric modalities in pedaling sessions (b) and (c)
大体时间：24 hours after pedaling sessions
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Change from baseline by ultrasonography measurements in the fascicle length of the vastus lateralis muscle.
Fascicle length was measured as the distance of a fibers between its insertion on the superficial aponeurosis and its insertions on the deep aponeurosis.
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24 hours after pedaling sessions
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Comparison of muscle echogenecity measured via ultrasonography on the vastus lateralis muscle after eccentric modality in pedaling session (a) and after concentric modalities in pedaling sessions (b) and (c)
大体时间：24 hours after pedaling sessions
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Change from baseline by ultrasonography measurements in echogenecity of the vastus lateralis muscle.
Echo intensity was determined based on the gray scale analysis of each pixel, the corresponding index of muscle quality ranging between 0 and 255 arbitrary units.
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24 hours after pedaling sessions
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Comparison of blood markers in session (a) and after concentric modalities in session (b) and session (c)
大体时间：24 hours after pedaling sessions
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Change from baseline of blood markers dosage.
Blood markers dosage investigated will: Reactive oxygen species (ROS), carbonylated protein, lipid peroxidation, antioxidant enzyme, proinflammatory cytokines, and muscle damage markers (creatine kinase, lactate dehydrogenase).
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24 hours after pedaling sessions
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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：Roland SCHOTT, MD、Institut de cancerologie Strasbourg Europe
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)
2021年11月22日
初级完成 (实际的)
2022年4月28日
研究完成 (实际的)
2022年4月28日
研究注册日期
首次提交
2021年11月24日
首先提交符合 QC 标准的
2021年12月8日
首次发布 (实际的)
2021年12月21日
研究记录更新
最后更新发布 (实际的)
2022年5月26日
上次提交的符合 QC 标准的更新
2022年5月25日
最后验证
2022年5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.
Session (a)的临床试验
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Florida State UniversityNational Institute on Drug Abuse (NIDA); National Center for Advancing Translational Sciences...完全的