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

May 12, 2021 updated by: Universidad Francisco de Vitoria

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Universidad Francisco de Vitoria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Use of FFP2 respirator
Using of FFP2 respirator during the 30 minutes test
Diagnostic test: steady intensity aerobic test of 30 minutes long
the use of different type of masks during an aerobic exercise
Active Comparator: Use of surgical mask
Using of surgical mask during the 30 minutes test
Diagnostic test: steady intensity aerobic test of 30 minutes long
the use of different type of masks during an aerobic exercise
Sham Comparator: no mask
The 30 minutes test will be carried out without mask
Diagnostic test: steady intensity aerobic test of 30 minutes long
the use of different type of masks during an aerobic exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Inspiratory muscle strength
Time Frame: change from baseline inspiratory muscle strength after the 30 minutes test
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
lactate concentrations
Time Frame: change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
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
oxygen saturation
Time Frame: change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
oxygen saturation will be measured in %
change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
heart rate
Time Frame: change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
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
rate of perceived effort
Time Frame: change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
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
sensation of dyspnea
Time Frame: change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Francisco de Vitoria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 3, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 3, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UFV_20/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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