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Surgical Face Mask Effects in Patients With COVID-19

NCT ID: NCT04689542

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-04-02

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.

Detailed Description

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Conditions

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Covid19

Keywords

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Sit-To-Stand test Surgical Facemask Dyspnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Surgical Facemask

The surgical facemask will be worn during the sit-to-stand test

Group Type EXPERIMENTAL

Sit-To-Stand test

Intervention Type OTHER

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

Control

No facemask will be worn during the sit-to-stand test

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sit-To-Stand test

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Poncin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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COSIT

Identifier Type: -

Identifier Source: org_study_id