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Clinical Trials/NCT04689542
NCT04689542CompletedNot Applicable

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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 sites in 1 country28 target enrollmentStarted: January 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
28
Locations
2
Primary Endpoint
Changes in dyspnea level

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Supportive Care
Masking
Double (Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Changes in respiratory rate(Before, immediately after and 2 minutes after the sit-to-stand test)
  • Changes in heart rate(Before, immediately after and 2 minutes after the sit-to-stand test)
  • Changes in pulsed oxygen saturation (SpO2)(Before, immediately after and 2 minutes after the sit-to-stand test)
  • Number of sit-to-stand repetition(1 minute)

Investigators

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Poncin

Principal Investigator

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Sites (2)

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