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Completed

NCT Number: NCT04832893

Use of Masks on Metabolic Parameters and Inspiratory Muscle Strength During 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.

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Key information

Conditions

Masks

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Francisco de Vitoria

Pozuelo de Alarcón, Madrid, 28223, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

steady intensity aerobic test of 30 minutes long

Diagnostic Test

the use of different type of masks during an aerobic exercise

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. oxygen saturation

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

    oxygen saturation will be measured in %

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Universidad Francisco de Vitoria

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 6, 2021
Registry last updated
May 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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