Treadmill Stress Test With and Without Mask (TREADMASK)
2021年7月26日 更新者：Université de Sherbrooke
Treadmill Stress Test With and Without Mask: Comparison of Exercise Capacity and Perception
The purpose of this study is to assess if wearing a surgical mask affects the results of a standard treadmill test.
研究概览
详细说明
The persons interested to participate will be informed of the implication and potential risks associated with the study.
The participants that accept and meet the eligibility criteria will give written consent and be randomized into two groups.
One group will first perform a treadmill test with a surgical mask and then repeat the test without a mask.
The second group will do the first treadmill test without a mask and the second one with a surgical mask.
研究类型
介入性
注册 (实际的)
35
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
-
-
Quebec
-
Sherbrooke、Quebec、加拿大、J1H 5N4
- Centre Hospitalier Universitaire de Sherbrooke
-
-
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 至 65年 (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:
- Adults (18-65 years old)
- Healthy
- Vaccinated against COVID-19
Exclusion Criteria:
- Any cardiac or respiratory condition
- Walking difficulty
- Waiting for a stress test for a medical reason
- Abnormal resting ECG
- Inability to wear a mask
- Inability to understand or follow the instructions
- Medical contraindication to performing a treadmill stress 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：随机化
- 介入模型：交叉作业
- 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：With, then without a mask
Participants will first perform a treadmill test with a mask and 48 hours or more later will perform another similar treadmill test without a mask.
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Treadmill test performed with and without a mask.
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|
实验性的：Without, then with a mask
Participants will first perform a treadmill test without a mask and 48 hours or more later will perform another similar treadmill test with a mask.
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Treadmill test performed with and without a mask.
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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 |
|---|---|---|
|
Change in Metabolic Equivalents With vs Without a Mask
大体时间：Through study completion, an average of 1 week
|
The maximal metabolic equivalents achieved will be calculated for each treadmill test performed.
|
Through study completion, an average of 1 week
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Borg's Category-Ratio Scale for Rating of Perceived Exertion With vs Without a Mask
大体时间：Through study completion, an average of 1 week
|
The Borg Scale is a self-reporting instrument assessing intensity of perceived exertion on a 0 to 10 scale, 0 being rest and 10 maximal effort.
|
Through study completion, an average of 1 week
|
其他结果措施
结果测量 |
大体时间 |
|---|---|
|
Change in Exercise Duration With vs Without a Mask
大体时间：Through study completion, an average of 1 week
|
Through study completion, an average of 1 week
|
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Change in Heart Rate During Exercise With vs Without a Mask
大体时间：Through study completion, an average of 1 week
|
Through study completion, an average of 1 week
|
|
Change in Blood Pressure During Exercise With vs Without a Mask
大体时间：Through study completion, an average of 1 week
|
Through study completion, an average of 1 week
|
|
Change in Oxygen Saturation During Exercise With vs Without a Mask
大体时间：Through study completion, an average of 1 week
|
Through study completion, an average of 1 week
|
|
Change in Duration of Exercise Before Reaching 85% of Predicted Maximal Heart Rate With vs Without a Mask
大体时间：Through study completion, an average of 1 week
|
Through study completion, an average of 1 week
|
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Change in Calculated Maximal Oxygen Consumption During Exercise With vs Without a Mask
大体时间：Through study completion, an average of 1 week
|
Through study completion, an average of 1 week
|
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：Warner Mampuya, MD, PhD、Université de Sherbrooke
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5月11日
初级完成 (实际的)
2021年6月16日
研究完成 (实际的)
2021年6月16日
研究注册日期
首次提交
2021年5月5日
首先提交符合 QC 标准的
2021年5月13日
首次发布 (实际的)
2021年5月18日
研究记录更新
最后更新发布 (实际的)
2021年7月27日
上次提交的符合 QC 标准的更新
2021年7月26日
最后验证
2021年7月1日
更多信息
与本研究相关的术语
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
All IPD that underlies results in a publication will be available in the supplementary appendix of the publication or on request.
IPD 共享时间框架
The data will be available at the time of the publication and for the 2 following years.
IPD 共享支持信息类型
- 研究协议
- 统计分析计划 (SAP)
- 知情同意书 (ICF)
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.