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

Primary Purpose

Masks

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
steady intensity aerobic test of 30 minutes long
Sponsored by
Universidad Francisco de Vitoria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Masks

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Universidad Francisco de Vitoria

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Use of FFP2 respirator

Use of surgical mask

no mask

Arm Description

Using of FFP2 respirator during the 30 minutes test

Using of surgical mask during the 30 minutes test

The 30 minutes test will be carried out without mask

Outcomes

Primary Outcome Measures

Inspiratory muscle strength
Inspiratory muscle strength will be measured in mmHg with a Power-breathe device

Secondary Outcome Measures

lactate concentrations
lactate concentration will be measured in mmol/L with a Lactate Pro 2 device
oxygen saturation
oxygen saturation will be measured in %
heart rate
heart rate will be measured in beats per minute with a polar H10 device
rate of perceived effort
rate of perceived effort will be obtained through the Borg´ scale
sensation of dyspnea
sensation of dyspnea will be obtained through a visual analog scale from 0 to 10 points

Full Information

First Posted
April 2, 2021
Last Updated
May 12, 2021
Sponsor
Universidad Francisco de Vitoria
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1. Study Identification

Unique Protocol Identification Number
NCT04832893
Brief Title
Use of Masks on Metabolic Parameters and Inspiratory Muscle Strength During Aerobic Exercise
Official Title
Effects of Different Masks on Metabolic Parameters, Inspiratory Muscle Strength and Perceived Effort During Low Intensity Aerobic Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
May 3, 2021 (Actual)
Study Completion Date
May 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Francisco de Vitoria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Masks

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Use of FFP2 respirator
Arm Type
Active Comparator
Arm Description
Using of FFP2 respirator during the 30 minutes test
Arm Title
Use of surgical mask
Arm Type
Active Comparator
Arm Description
Using of surgical mask during the 30 minutes test
Arm Title
no mask
Arm Type
Sham Comparator
Arm Description
The 30 minutes test will be carried out without mask
Intervention Type
Diagnostic Test
Intervention Name(s)
steady intensity aerobic test of 30 minutes long
Intervention Description
the use of different type of masks during an aerobic exercise
Primary Outcome Measure Information:
Title
Inspiratory muscle strength
Description
Inspiratory muscle strength will be measured in mmHg with a Power-breathe device
Time Frame
change from baseline inspiratory muscle strength after the 30 minutes test
Secondary Outcome Measure Information:
Title
lactate concentrations
Description
lactate concentration will be measured in mmol/L with a Lactate Pro 2 device
Time Frame
change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
Title
oxygen saturation
Description
oxygen saturation will be measured in %
Time Frame
change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
Title
heart rate
Description
heart rate will be measured in beats per minute with a polar H10 device
Time Frame
change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
Title
rate of perceived effort
Description
rate of perceived effort will be obtained through the Borg´ scale
Time Frame
change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
Title
sensation of dyspnea
Description
sensation of dyspnea will be obtained through a visual analog scale from 0 to 10 points
Time Frame
change from baseline after 10 minutes, 20 minutes and 30 minutes during the test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: carrying out at least 2 days of physical activity per week Exclusion Criteria: cardiac disease pulmonary disease chronic inflammatory disease sedentary behaviour
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davinia Vicente Campos, PhD
Organizational Affiliation
Universidad Francisco de Vitoria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Francisco de Vitoria
City
Pozuelo de Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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

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