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Surgical Face Mask Effects in Patients With COVID-19

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04689542
Enrollment
28
Registered
2020-12-30
Start date
2021-01-01
Completion date
2021-04-02
Last updated
2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

Sit-To-Stand test, Surgical Facemask, Dyspnea

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.

Interventions

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

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Changes in dyspnea levelBefore, immediately after and 2 minutes after the sit-to-stand testThe Modified Borg dyspnea scale will be used to estimate dyspnea This scale range from 0 (no dyspnea) to 10 (maximal dyspnea)

Secondary

MeasureTime frameDescription
Changes in respiratory rateBefore, immediately after and 2 minutes after the sit-to-stand testRespiratory rate will be measured using two inductive plethysmography belts
Changes in heart rateBefore, immediately after and 2 minutes after the sit-to-stand testHeart rate will be measured using a pulse oximeter
Changes in pulsed oxygen saturation (SpO2)Before, immediately after and 2 minutes after the sit-to-stand testSpO2 will be measured using a pulse oximeter
Number of sit-to-stand repetition1 minuteThe number of repetitions will be manually counted

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026