- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04932226
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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Oxfordshire
-
Oxford, Oxfordshire, 영국, OX2 6GG
- Trisha Greenhalgh
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: 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
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Oxygen saturation
기간: Immediately after exercise
|
Oxygen saturation using pulse oximeter
|
Immediately after exercise
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
heart rate
기간: immediately after exercise
|
Heart rate
|
immediately after exercise
|
|
distance traveled
기간: immediately after exercise
|
distance traveled as a % of distance traveled when unmasked
|
immediately after exercise
|
|
comfort
기간: immediately after exercise
|
symptom survey of mask comfort and any adverse effects
|
immediately after exercise
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- PHC_facemasks&exercise1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구 프로토콜
- 통계 분석 계획(SAP)
- 정보에 입각한 동의서(ICF)
- 임상 연구 보고서(CSR)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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