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

NCT04832893 | Completed

• 1 other identifier: UFV_20/2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Masks

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• lactate concentrations

  change from baseline after 10 minutes, 20 minutes and 30 minutes during the test

• oxygen saturation

  change from baseline after 10 minutes, 20 minutes and 30 minutes during the test

• heart rate

  change from baseline after 10 minutes, 20 minutes and 30 minutes during the test

• rate of perceived effort

  change from baseline after 10 minutes, 20 minutes and 30 minutes during the test

• sensation of dyspnea

  change from baseline after 10 minutes, 20 minutes and 30 minutes during the test

Study Arms (3)

Use of FFP2 respirator

ACTIVE COMPARATOR

Using of FFP2 respirator during the 30 minutes test

Diagnostic Test: steady intensity aerobic test of 30 minutes long

Use of surgical mask

ACTIVE COMPARATOR

Using of surgical mask during the 30 minutes test

Diagnostic Test: steady intensity aerobic test of 30 minutes long

no mask

SHAM COMPARATOR

The 30 minutes test will be carried out without mask

Diagnostic Test: steady intensity aerobic test of 30 minutes long

Interventions

steady intensity aerobic test of 30 minutes long DIAGNOSTIC_TEST

the use of different type of masks during an aerobic exercise

Use of FFP2 respirator; Use of surgical mask; no mask

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• cardiac disease
• pulmonary disease
• chronic inflammatory disease
• sedentary behaviour

Sponsors & Collaborators

• Universidad Francisco de Vitoria: lead

Study Sites (1)

Universidad Francisco de Vitoria

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Study Officials

• Davinia Vicente Campos, PhD

  Universidad Francisco de Vitoria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 6, 2021
• Study Start: April 12, 2021
• Primary Completion: May 3, 2021
• Study Completion: May 3, 2021
• Last Updated: May 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)