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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Oxfordshire
-
Oxford、Oxfordshire、イギリス、OX2 6GG
- Trisha Greenhalgh
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:ヘルスサービス研究
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の: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
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Oxygen saturation
時間枠:Immediately after exercise
|
Oxygen saturation using pulse oximeter
|
Immediately after exercise
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
heart rate
時間枠:immediately after exercise
|
Heart rate
|
immediately after exercise
|
|
distance traveled
時間枠:immediately after exercise
|
distance traveled as a % of distance traveled when unmasked
|
immediately after exercise
|
|
comfort
時間枠:immediately after exercise
|
symptom survey of mask comfort and any adverse effects
|
immediately after exercise
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- PHC_facemasks&exercise1
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- 研究プロトコル
- 統計分析計画 (SAP)
- インフォームド コンセント フォーム (ICF)
- 臨床試験報告書(CSR)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。