Face Masks and Oxygen Levels - What Happens During Exercise? (Masks in Exercise - a RandomIsed Trial) (MERIT)
Peripheral Oxygen Saturations Among Healthy Young Adults Wearing Face Masks Whilst Exercising
研究概览
详细说明
The investigators will conduct a crossover study comparing three different types of face mask (cloth, surgical or filtering facepiece respirator - FFR) versus no face mask to determine the effect on oxygen saturations, heart rate and symptoms of healthy young adults during 15 minutes of moderate to high intensity exercise. The investigators will promote the study through sports societies at three leading United Kingdom (UK) universities, namely the University of Oxford, University of Nottingham and King's College London. The investigators will also advertise the study on social media.
Interested individuals will be encouraged to visit the study website or read the patient information sheets available to share via email. Volunteer participants will be asked to read the eligibility criteria, patient information sheet and recruitment information before applying to take part. Those who wish to participate will be asked to complete an online form, including their first name, date of birth, address, email address, demographics, details of their regular exercise and details of any past medical history or medication.
Those wishing to discuss the study will have the opportunity to request a phone call from a member of the study team before agreeing to take part.
Submitted applications will be screened by the study team for eligibility. Those who are deemed not to be eligible will be contacted, explaining the reason. Selected participants will be informed and contacted to arrange a date for the study session. This will be conducted at their local university sports centre or a local park. The number of participants attending a single study session will be in compliance with any UK government restrictions relating to COVID-19 in place at that time.
On the day of the study, participants will meet a member of the study team, who will ask them to complete an online consent form.
Participants will then be asked to complete an exercise study session. The type of exercise will be either:
- Running
- Cycling
- Rowing on a fixed machine
Participants will be asked to complete four x 15 minute pieces of exercise within this single session. The aim will be to exercise at moderate to high intensity with the goal of covering the same distance each time. Between 15 minutes of exercise, participants will be asked to take a 5 minute rest break. For each 15 minute session, participants will wear one of the following:
- a cloth mask
- a surgical mask
- a FFR
- no mask
The order in which participants wear the face masks will be determined by a random sequence generator(https://www.phc.ox.ac.uk/research/technology-outputs/sortition-clinical-trial-randomisation-software). The masks will be provided by the researcher at the time.
Participants will wear no mask during each rest period. Prior to starting, participants will have their resting heart rate and oxygen levels recorded. Halfway through each exercise period, immediately on completing the exercise and at 1 minute following completion of the exercise, participants will have their heart rate, oxygen levels and distance travelled recorded by a member of the study team.
Upon completion of the exercise session, participants will be asked to complete an online survey via a secure portal, hosted by the University of Oxford. They will be asked to complete questions regarding the type of exercise they did, oxygen levels and heart rate at each time point, distance travelled and average speed, and questions regarding the ease of exercise and comfort of wearing each masks, as well as any additional symptoms they might have experienced during the exercise session as a result of wearing the mask.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Oxfordshire
-
Oxford、Oxfordshire、英国、OX2 6GG
- Trisha Greenhalgh
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male or Female, aged 18 - 35 years old.
- Exercise at least three times a week on a regular basis.
- Participant is willing and able to give informed consent for participation in the study.
Exclusion Criteria:
- Known to have a significant acute or longstanding medical illness that limits their exercise capacity.
- Develop symptoms of anosmia, cough or fever between agreeing to participate and completing the exercise, suggesting they may have developed COVID-19.
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 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 |
---|---|
其他:All participants
Each participant is his/her own control.
Each will have all four interventions in random order.
|
Buff bandana double layer worn over nose and mouth
standard surgical mask
filtering facepiece 2 respirator
|
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 |
---|---|---|
Oxygen saturation
大体时间:Immediately after exercise
|
Oxygen saturation using pulse oximeter
|
Immediately after exercise
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
heart rate
大体时间:immediately after exercise
|
Heart rate
|
immediately after exercise
|
distance traveled
大体时间:immediately after exercise
|
distance traveled as a % of distance traveled when unmasked
|
immediately after exercise
|
comfort
大体时间:immediately after exercise
|
symptom survey of mask comfort and any adverse effects
|
immediately after exercise
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- PHC_facemasks&exercise1
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
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)
- 临床研究报告(CSR)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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.
cloth mask的临床试验
-
Northern Health and Social Care TrustAntrim Area Hospital完全的
-
University of North Carolina, Chapel HillUniversity of Michigan; University of Washington; University of Texas Southwestern Medical Center 和其他合作者招聘中