Surgical Face Mask Effects in Patients With COVID-19

Study Overview
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Brief Summary
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The use of personal protective equipment is mandatory for healthcare workers caring patient with COVID-19. To maximise the reduction of virus spread during clinical procedures involving the presence of healthcare workers, it is also recommended to patients to wear surgical facemask. Routine clinical procedures include cardio-pulmonary and strengthening exercises. During these exercises, the wearing of a face mask may be difficult to tolerate by patients, especially since they experience breathing difficulties due to the illness. Therefore, this study aims to verify the effects of the surgical facemask on breathing difficulties and exercise performance during a 1-minute sit to stand test.

Official Title
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Effects of Surgical Face Mask on Submaximal Exercise Test in Patients With COVID-19

Conditions
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Covid19

Intervention / Treatment
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* Other: Sit-To-Stand test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized for COVID-19 No need of supplemental oxygen during the procedure Exclusion Criteria: Altered state of consciousness Respiratory co-morbidities Neurological or orthopedic co-morbidities susceptible to alter the reliability of the sit-to-stand test Having required high flow nasal cannula or non-invasive ventilation during the hospital stay

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical Facemask<br>The surgical facemask will be worn during the sit-to-stand test | Other: Sit-To-Stand test<br>* The 1-minute sit-to-stand test will be realized with or without a surgical facemask covering the face of the patient with COVID-19<br>|
| No Intervention: Control<br>No facemask will be worn during the sit-to-stand test | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in dyspnea level | The Modified Borg dyspnea scale will be used to estimate dyspnea This scale range from 0 (no dyspnea) to 10 (maximal dyspnea) | Before, immediately after and 2 minutes after the sit-to-stand test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in respiratory rate | Respiratory rate will be measured using two inductive plethysmography belts | Before, immediately after and 2 minutes after the sit-to-stand test | 
| Changes in heart rate | Heart rate will be measured using a pulse oximeter | Before, immediately after and 2 minutes after the sit-to-stand test | 
| Changes in pulsed oxygen saturation (SpO2) | SpO2 will be measured using a pulse oximeter | Before, immediately after and 2 minutes after the sit-to-stand test | 
| Number of sit-to-stand repetition | The number of repetitions will be manually counted | 1 minute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sit-To-Stand test, Surgical Facemask, Dyspnea