Use of Masks on Metabolic Parameters and Inspiratory Muscle Strength During Aerobic Exercise

Masks Clinical Trial

Official title:

Effects of Different Masks on Metabolic Parameters, Inspiratory Muscle Strength and Perceived Effort During Low Intensity Aerobic Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04832893
• Other study ID #: UFV_20/2021
• Status: Completed
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: May 3, 2021

Study information

• Verified date: April 2021
• Source: Universidad Francisco de Vitoria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study will be to assess the effects of the use of masks on inspiratory muscle strength, metabolic parameters, heart rate, subjective perception of effort and the sensation of dyspnea before, during and after an aerobic test of 30 minutes long and a fixed load at lactate threshold. A randomized study of repeated measures will be carried out. A total sample of 35 active participants will be recruited. All participants will carried out a lactate threshold test and then 3 visits to the laboratory (separated at least 48 hours from each other) in order to perform 3 test of 30 minutes long without mask, with a surgical mask or with a FFP2 respirator (in a randomized order) at an intensity around lactate threshold intensity. Maximal inspiratory pressure, oxygen saturation, heart rate, blood lactate concentration, subjective perception of effort and dyspnea will be assessed before, during and after the 3 fixed intensity tests.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 3, 2021
• Est. primary completion date: May 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• carrying out at least 2 days of physical activity per week

Exclusion Criteria:

• cardiac disease

• pulmonary disease

• chronic inflammatory disease

• sedentary behaviour

Related Conditions & MeSH terms

• Masks
• Respiratory Aspiration

Intervention

Diagnostic Test:
• steady intensity aerobic test of 30 minutes long
the use of different type of masks during an aerobic exercise

Locations

Country	Name	City	State
Spain	Universidad Francisco de Vitoria	Pozuelo de Alarcón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Francisco de Vitoria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inspiratory muscle strength	Inspiratory muscle strength will be measured in mmHg with a Power-breathe device	change from baseline inspiratory muscle strength after the 30 minutes test
Secondary	lactate concentrations	lactate concentration will be measured in mmol/L with a Lactate Pro 2 device	change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
Secondary	oxygen saturation	oxygen saturation will be measured in %	change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
Secondary	heart rate	heart rate will be measured in beats per minute with a polar H10 device	change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
Secondary	rate of perceived effort	rate of perceived effort will be obtained through the Borg´ scale	change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
Secondary	sensation of dyspnea	sensation of dyspnea will be obtained through a visual analog scale from 0 to 10 points	change from baseline after 10 minutes, 20 minutes and 30 minutes during the test