Surgical Face Mask Effects in Patients With COVID-19

November 5, 2021 updated by: Poncin, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Surgical Facemask
The surgical facemask will be worn during the sit-to-stand test
Other: 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
NO_INTERVENTION: Control
No facemask will be worn during the sit-to-stand test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in dyspnea level
Time Frame: Before, immediately after and 2 minutes after the sit-to-stand test
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
Time Frame: Before, immediately after and 2 minutes after the sit-to-stand test
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
Time Frame: Before, immediately after and 2 minutes after the sit-to-stand test
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)
Time Frame: Before, immediately after and 2 minutes after the sit-to-stand test
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
Time Frame: 1 minute
The number of repetitions will be manually counted
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2021

Primary Completion (ACTUAL)

April 2, 2021

Study Completion (ACTUAL)

April 2, 2021

Study Registration Dates

First Submitted

December 29, 2020

First Submitted That Met QC Criteria

December 29, 2020

First Posted (ACTUAL)

December 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COSIT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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