Physical FitnessMaskFITNCT04800848
Effects of the Face Mask on Physical Fitness in Children
An observational study of Physical Fitness and Health, run by University of Oviedo at 1 site in Spain.
Trial summary
The aim of this multicenter randomized crossover design study is to evaluate a sample of 500 boys and girls from public and private schools in the Principality of Asturias, aged between 6 and 12 years, with the objective of determining the level of physical condition, as well as to evaluate the effect of the use of… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Fitness, Health, Childhood ALL
- What is being tested?
- Mask
- Type of treatment
- Medical device
- How many people
- 165 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2021to 1 Jul 2021
- Phase
- Observational
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children between 6 an 12 years that attend classes in state or private schools.
Who may be able to join
- Age between 6 and 12 years old.
- Be able to perform all the tests and procedures that comprise the study.
- Have signed informed parental consent.
Who cannot join
- To take drugs that can affect the measurements
- Contraindications or pathologies associated with exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the N95/FFP2 Face Mask on Physical Fitness in Children
The aim of this multicenter randomized crossover design study is to evaluate a sample of 500 boys and girls from public and private schools in the Principality of Asturias, aged between 6 and 12 years, with the objective of determining the level of physical condition, as well as to evaluate the effect of the use of FFP2/N95 face masks during the execution of the ALPHA Fitness battery, and the emotional effects caused by the use of these masks. This is a sample obtained by accessibility, in which the sampling will be stratified by age and academic year.
- Conditions
- Physical Fitness, Health, Childhood ALL, Emotional Stress, Sedentary Behavior, Cardiorespiratory Fitness
- Being tested
- Mask
- Keywords
- Exercise, Alpha fitness battery, Kids, N95/FFP2, Physical Activity, CDI
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Stress, Psychological, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaskDevice
Physical Fitness is evaluated with the use of a face mask
| Study group | Role | What they receive |
|---|---|---|
| Mask/No Mask | The group will perform both situations in a randomized cross-over design:
* 1. Scholars will perform the fitness test with the use of a N95/FFP2 face mask
* 2. Scholars will perform the fitness test without the use of a N95/FFP2 face mask Receives: Device: Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
The Physical Activity Questionnaire for Children (PAQ-C) will be administered to determine the amount and intensity of physical activity that children perform during a week. It consists of ten items, nine of which are used to calculate the activity level and the other item assesses whether any illness or other event prevented the child from doing regular activities in the last week. The overall result of the test is a score from 1 to 5, with higher scores indicating a higher level of activity.
Measured: at the beginning of the study (Day 1)
Sedentarism
In order to know the sedentary behaviors of schoolchildren, a questionnaire will be passed to them that seeks to know the time they habitually dedicate to various sedentary behaviors. The questionnaire assess the amount of time spent doing 6 behaviors (watching television, playing computer, playing video games, surfing the Internet for hobby, surfing the Internet by study, sitting and studying). The 6 items were completed separately for weekdays and weekend days. With a scale from 1 to 7, such that higher scores indicate a higher level of sedentary lifestyle.
Measured: at the beginning of the study (Day 1)
Emotional states
To evaluate the emotional state, the Children's Depression Inventory (CDI) questionnaire will be implemented, which consists of two scales: dysphoria (depressive mood, sadness, worry, etc.) and negative self-esteem (judgments of inefficiency, ugliness, badness, etc.) with which to measure the effects of the pandemic on the child population and the situation of anxiety that it produces. The questionnaire will be answered directly by the children, as a self-report.
The original version has 27 items, with five subscales within the assessment that measure different components of depression, with three response options for each item.
Measured: at the beginning of the study (Day 1)
Handgrip strength
The isometric strength of the upper body (manual grip) using a manual dynamometer with adjustable grip (Takei TKK-5401) and for this purpose there is a table-rule to adjust the grip according to the length of the subject's palm. The test will be performed twice, alternately with both hands, and the best result obtained will be recorded.
Measured: at the beginning of the study (Day 1)
Horizontal Jump
The test will be carried out with or without face mask depending on the cross design.
The horizontal jump with feet together measures the explosive strength of the lower body. Each student will perform the test twice and the best result obtained will be recorded. If in either of the two attempts the child falls backwards or contacts the surface with a part of the body other than the feet, a new jump will be allowed.
Measured: at the beginning of the study (Day 1)
Horizontal Jump
Those who performed the first measurement with a face mask, in the second measurement will perform the test without a face mask, and vice versa.
The horizontal jump with feet together measures the explosive strength of the lower body. Each student will perform the test twice and the best result obtained will be recorded. If in either of the two attempts the child falls backwards or contacts the surface with a part of the body other than the feet, a new jump will be allowed.
Measured: Day 2 (two weeks later)
Speed and agility
The test will be carried out with or without face mask depending on the cross design.
The 4 x 10m speed and agility test measures speed of movement, agility and coordination. Participants will perform the test twice, with the best result being recorded in seconds to one decimal place. The test will be performed on a non-slip surface so that there is no possibility of slipping.
Measured: at the beginning of the study (Day 1)
Speed and agility
Those who performed the first measurement with a face mask, in the second measurement will perform the test without a face mask, and vice versa.
The 4 x 10m speed and agility test measures speed of movement, agility and coordination. Participants will perform the test twice, with the best result being recorded in seconds to one decimal place. The test will be performed on a non-slip surface so that there is no possibility of slipping.
Measured: Day 2 (two weeks later)
Aerobic capacity
The test will be carried out with or without face mask depending on the cross design.
The 20m shuttle run test also known as 'Course Navette' is a maximal effort test that measures the maximum aerobic capacity, allowing to know the current and future cardiovascular health profile of the children who perform the study. The test will be performed once, over a uniform surface of 30 meters, 20 meters of which will be used for the test. When the child stops, the last stage or number announced by a CD with the test protocol will be recorded, which will set the pace to be followed throughout the test. The test will be executed individually as a preventive measure.
Measured: at the beginning of the study (Day 1)
Aerobic capacity
Those who performed the first measurement with a face mask, in the second measurement will perform the test without a face mask, and vice versa.
The 20m shuttle run test also known as 'Course Navette' is a maximal effort test that measures the maximum aerobic capacity, allowing to know the current and future cardiovascular health profile of the children who perform the study. The test will be performed once, over a uniform surface of 30 meters, 20 meters of which will be used for the test. When the child stops, the last stage or number announced by a CD with the test protocol will be recorded, which will set the pace to be followed throughout the test. The test will be executed individually as a preventive measure.
Measured: Day 2 (two weeks later)
Comfort with the use of masks
The test will be carried out with or without face mask depending on the cross design. A visual scale which allow to measure the perception of the comfort level of the students with and without the N95/FFP2 face masks just after finished each test of the Alpha Fitness Battery. It is a visual scale from 0 to 10, ranging from comfortable, uncomfortable to extremely uncomfortable.
Measured: at the beginning of the study (Day 1)
Comfort with the use of masks
Those who performed the first measurement with a face mask, in the second measurement will perform the test without a face mask, and vice versa.
A visual scale which allow to measure the perception of the comfort level of the students with and without the N95/FFP2 face masks just after finished each test of the Alpha Fitness Battery. It is a visual scale from 0 to 10, ranging from comfortable, uncomfortable to extremely uncomfortable.
Measured: Day 2 (two weeks later)
Height
Height is measured with a height rod to the nearest 0.1 cm (SECA 225, SECA, Hamburg, Germany),
Measured: at the beginning of the study (Day 1)
Weight
Weight of the children is measured by a 0.1 kg precision bascule (SECA 861, SECA, Hamburg, Germany)
Measured: at the beginning of the study (Day 1)
waist circumference
The waist circumference are measured following the ISAK protocol and measurement technique with an anthropometric tape (Holtain).
Measured: at the beginning of the study (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Apr 2021
- Primary completion1 May 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical FitnessStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hugo Olmedillas Fernandez, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800848
- Sponsor's protocol ID
- UO2021-01
- Acronym
- MaskFIT
- Status last verified
- Jul 2021
- First submitted
- 9 Mar 2021
- Last updated
- 20 Jul 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 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the N95/FFP2 Face Mask on Physical Fitness in Children
- ClinicalTrials.gov ID
- NCT04800848
- Acronym / sponsor ID
- MaskFIT / UO2021-01
- Conditions
- Physical Fitness, Health, Childhood ALL, Emotional Stress, Sedentary Behavior, Cardiorespiratory Fitness
- Keywords
- Exercise, Alpha fitness battery, Kids, N95/FFP2, Physical Activity, CDI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 16 Mar 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 aim of this multicenter randomized crossover design study is to evaluate a sample of 500 boys and girls from public and private schools in the Principality of Asturias, aged between 6 and 12 years, with the objective of determining the level of physical condition, as well as to evaluate the effect of the use of FFP2/N95 face masks during the execution of the ALPHA Fitness battery, and the emotional effects caused by the use of these masks. This is a sample obtained by accessibility, in which the sampling will be stratified by age and academic year.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mask/No Mask | – | Device: MaskThe group will perform both situations in a randomized cross-over design: * 1. Scholars will perform the fitness test with the use of a N95/FFP2 face mask * 2. Scholars will perform the fitness test without the use of a N95/FFP2 face mask |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children between 6 an 12 years that attend classes in state or private schools.
Key inclusion criteria (3 listed)
- Age between 6 and 12 years old.
- Be able to perform all the tests and procedures that comprise the study.
- Have signed informed parental consent.
Key exclusion criteria (2 listed)
- To take drugs that can affect the measurements
- Contraindications or pathologies associated with exercise
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 |
|---|---|---|
| MaskPhysical Fitness is evaluated with the use of a face mask | Device | Mask/No Mask |
Primary outcome
Physical Activity
Time frame: at the beginning of the study (Day 1)
The Physical Activity Questionnaire for Children (PAQ-C) will be administered to determine the amount and intensity of physical activity that children perform during a week. It consists of ten items, nine of which are used to calculate the activity level and the other item assesses whether any illness or other event prevented the child from doing regular activities in the last week. The overall result of the test is a score from 1 to 5, with higher scores indicating a higher level of activity.
Sedentarism
Time frame: at the beginning of the study (Day 1)
In order to know the sedentary behaviors of schoolchildren, a questionnaire will be passed to them that seeks to know the time they habitually dedicate to various sedentary behaviors. The questionnaire assess the amount of time spent doing 6 behaviors (watching television, playing computer, playing video games, surfing the Internet for hobby, surfing the Internet by study, sitting and studying). The 6 items were completed separately for weekdays and weekend days. With a scale from 1 to 7, such that higher scores indicate a higher level of sedentary lifestyle.
Emotional states
Time frame: at the beginning of the study (Day 1)
To evaluate the emotional state, the Children's Depression Inventory (CDI) questionnaire will be implemented, which consists of two scales: dysphoria (depressive mood, sadness, worry, etc.) and negative self-esteem (judgments of inefficiency, ugliness, badness, etc.) with which to measure the effects of the pandemic on the child population and the situation of anxiety that it produces. The questionnaire will be answered directly by the children, as a self-report. The original version has 27 items, with five subscales within the assessment that measure different components of depression, with three response options for each item.
Handgrip strength
Time frame: at the beginning of the study (Day 1)
The isometric strength of the upper body (manual grip) using a manual dynamometer with adjustable grip (Takei TKK-5401) and for this purpose there is a table-rule to adjust the grip according to the length of the subject's palm. The test will be performed twice, alternately with both hands, and the best result obtained will be recorded.
Horizontal Jump
Time frame: at the beginning of the study (Day 1)
The test will be carried out with or without face mask depending on the cross design. The horizontal jump with feet together measures the explosive strength of the lower body. Each student will perform the test twice and the best result obtained will be recorded. If in either of the two attempts the child falls backwards or contacts the surface with a part of the body other than the feet, a new jump will be allowed.
Horizontal Jump
Time frame: Day 2 (two weeks later)
Those who performed the first measurement with a face mask, in the second measurement will perform the test without a face mask, and vice versa. The horizontal jump with feet together measures the explosive strength of the lower body. Each student will perform the test twice and the best result obtained will be recorded. If in either of the two attempts the child falls backwards or contacts the surface with a part of the body other than the feet, a new jump will be allowed.
Speed and agility
Time frame: at the beginning of the study (Day 1)
The test will be carried out with or without face mask depending on the cross design. The 4 x 10m speed and agility test measures speed of movement, agility and coordination. Participants will perform the test twice, with the best result being recorded in seconds to one decimal place. The test will be performed on a non-slip surface so that there is no possibility of slipping.
Speed and agility
Time frame: Day 2 (two weeks later)
Those who performed the first measurement with a face mask, in the second measurement will perform the test without a face mask, and vice versa. The 4 x 10m speed and agility test measures speed of movement, agility and coordination. Participants will perform the test twice, with the best result being recorded in seconds to one decimal place. The test will be performed on a non-slip surface so that there is no possibility of slipping.
Aerobic capacity
Time frame: at the beginning of the study (Day 1)
The test will be carried out with or without face mask depending on the cross design. The 20m shuttle run test also known as 'Course Navette' is a maximal effort test that measures the maximum aerobic capacity, allowing to know the current and future cardiovascular health profile of the children who perform the study. The test will be performed once, over a uniform surface of 30 meters, 20 meters of which will be used for the test. When the child stops, the last stage or number announced by a CD with the test protocol will be recorded, which will set the pace to be followed throughout the test. The test will be executed individually as a preventive measure.
Aerobic capacity
Time frame: Day 2 (two weeks later)
Those who performed the first measurement with a face mask, in the second measurement will perform the test without a face mask, and vice versa. The 20m shuttle run test also known as 'Course Navette' is a maximal effort test that measures the maximum aerobic capacity, allowing to know the current and future cardiovascular health profile of the children who perform the study. The test will be performed once, over a uniform surface of 30 meters, 20 meters of which will be used for the test. When the child stops, the last stage or number announced by a CD with the test protocol will be recorded, which will set the pace to be followed throughout the test. The test will be executed individually as a preventive measure.
Comfort with the use of masks
Time frame: at the beginning of the study (Day 1)
The test will be carried out with or without face mask depending on the cross design. A visual scale which allow to measure the perception of the comfort level of the students with and without the N95/FFP2 face masks just after finished each test of the Alpha Fitness Battery. It is a visual scale from 0 to 10, ranging from comfortable, uncomfortable to extremely uncomfortable.
Comfort with the use of masks
Time frame: Day 2 (two weeks later)
Those who performed the first measurement with a face mask, in the second measurement will perform the test without a face mask, and vice versa. A visual scale which allow to measure the perception of the comfort level of the students with and without the N95/FFP2 face masks just after finished each test of the Alpha Fitness Battery. It is a visual scale from 0 to 10, ranging from comfortable, uncomfortable to extremely uncomfortable.
Height
Time frame: at the beginning of the study (Day 1)
Height is measured with a height rod to the nearest 0.1 cm (SECA 225, SECA, Hamburg, Germany),
Weight
Time frame: at the beginning of the study (Day 1)
Weight of the children is measured by a 0.1 kg precision bascule (SECA 861, SECA, Hamburg, Germany)
waist circumference
Time frame: at the beginning of the study (Day 1)
The waist circumference are measured following the ISAK protocol and measurement technique with an anthropometric tape (Holtain).
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 20 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Fitness and Health, run by University of Oviedo 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 3 inclusion and 2 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 20 Jul 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. 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?
Physical Activity (time frame: at the beginning of the study (Day 1)). The study lists 15 primary outcomes in all. 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 20 Jul 2021.