MasksNCT04832893
Use of Masks on Metabolic Parameters and Inspiratory Muscle Strength During Aerobic Exercise
A study testing steady intensity aerobic test of 30 minutes long in people with Masks, run by Universidad Francisco de Vitoria at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Masks
- What is being tested?
- steady intensity aerobic test of 30 minutes long
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 12 Apr 2021to 3 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- carrying out at least 2 days of physical activity per week
Who cannot join
- cardiac disease
- pulmonary disease
- chronic inflammatory disease
- sedentary behaviour
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Masks
- Being tested
- steady intensity aerobic test of 30 minutes long
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
steady intensity aerobic test of 30 minutes longDiagnostic test
the use of different type of masks during an aerobic exercise
| Study group | Role | What they receive |
|---|---|---|
| Use of FFP2 respirator | Active comparator | Using of FFP2 respirator during the 30 minutes test Receives: 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 Receives: Diagnostic Test: steady intensity aerobic test of 30 minutes long |
| no mask | Sham comparator | The 30 minutes test will be carried out without mask Receives: Diagnostic Test: steady intensity aerobic test of 30 minutes long |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory muscle strength
Inspiratory muscle strength will be measured in mmHg with a Power-breathe device
Measured: change from baseline inspiratory muscle strength after the 30 minutes test
Secondary outcomes (5)
lactate concentrations
lactate concentration will be measured in mmol/L with a Lactate Pro 2 device
Measured: change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
oxygen saturation
oxygen saturation will be measured in %
Measured: change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
heart rate
heart rate will be measured in beats per minute with a polar H10 device
Measured: change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
rate of perceived effort
rate of perceived effort will be obtained through the Borg´ scale
Measured: change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
sensation of dyspnea
sensation of dyspnea will be obtained through a visual analog scale from 0 to 10 points
Measured: change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start12 Apr 2021
- Primary completion3 May 2021
- Study completion3 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MasksStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Davinia Vicente Campos, PhD, Principal investigator, Universidad Francisco de Vitoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832893
- Sponsor's protocol ID
- UFV_20/2021
- Status last verified
- Apr 2021
- First submitted
- 2 Apr 2021
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Masks on Metabolic Parameters, Inspiratory Muscle Strength and Perceived Effort During Low Intensity Aerobic Exercise
- ClinicalTrials.gov ID
- NCT04832893
- Acronym / sponsor ID
- UFV_20/2021
- Conditions
- Masks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Use of FFP2 respirator | Active comparator | Diagnostic Test: steady intensity aerobic test of 30 minutes longUsing of FFP2 respirator during the 30 minutes test |
| Use of surgical mask | Active comparator | Diagnostic Test: steady intensity aerobic test of 30 minutes longUsing of surgical mask during the 30 minutes test |
| no mask | Sham comparator | Diagnostic Test: steady intensity aerobic test of 30 minutes longThe 30 minutes test will be carried out without mask |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- carrying out at least 2 days of physical activity per week
Key exclusion criteria (4 listed)
- cardiac disease
- pulmonary disease
- chronic inflammatory disease
- sedentary behaviour
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| steady intensity aerobic test of 30 minutes longthe use of different type of masks during an aerobic exercise | Diagnostic test | Use of FFP2 respirator, Use of surgical mask, no mask |
Primary outcome
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
5 secondary outcomes
lactate concentrations
Time frame: 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
heart rate
Time frame: 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
sensation of dyspnea
Time frame: change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davinia Vicente Campos, PhD principal investigator
Universidad Francisco de Vitoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing steady intensity aerobic test of 30 minutes long in people with Masks, run by Universidad Francisco de Vitoria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory muscle strength (time frame: change from baseline inspiratory muscle strength after the 30 minutes test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.