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

NCT ID: NCT04832893

Last Updated: 2021-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-12

Study Completion Date

2021-05-03

Brief Summary

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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.

Detailed Description

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Conditions

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Masks

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Use of FFP2 respirator

Using of FFP2 respirator during the 30 minutes test

Group Type ACTIVE_COMPARATOR

steady intensity aerobic test of 30 minutes long

Intervention Type DIAGNOSTIC_TEST

the use of different type of masks during an aerobic exercise

Use of surgical mask

Using of surgical mask during the 30 minutes test

Group Type ACTIVE_COMPARATOR

steady intensity aerobic test of 30 minutes long

Intervention Type DIAGNOSTIC_TEST

the use of different type of masks during an aerobic exercise

no mask

The 30 minutes test will be carried out without mask

Group Type SHAM_COMPARATOR

steady intensity aerobic test of 30 minutes long

Intervention Type DIAGNOSTIC_TEST

the use of different type of masks during an aerobic exercise

Interventions

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steady intensity aerobic test of 30 minutes long

the use of different type of masks during an aerobic exercise

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* cardiac disease
* pulmonary disease
* chronic inflammatory disease
* sedentary behaviour
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Francisco de Vitoria

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Davinia Vicente Campos, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Francisco de Vitoria

Locations

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Universidad Francisco de Vitoria

Pozuelo de Alarcón, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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UFV_20/2021

Identifier Type: -

Identifier Source: org_study_id

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