Effects of the Face Mask on Physical Fitness in Children

NCT04800848 | Completed

• 1 other identifier: UO2021-01
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Exercise; Alpha fitness battery; Kids; N95/FFP2; Physical Activity; CDI

Outcome Measures

Primary Outcomes (15)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Day 2 (two weeks later)

• Height

  Height is measured with a height rod to the nearest 0.1 cm (SECA 225, SECA, Hamburg, Germany),

  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)

  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).

  at the beginning of the study (Day 1)

Study Arms (1)

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

Device: Mask

Interventions

Mask DEVICE

Physical Fitness is evaluated with the use of a face mask

Mask/No Mask

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children between 6 an 12 years that attend classes in state or private schools.

You may qualify if:

• 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.

You may not qualify if:

• To take drugs that can affect the measurements
• Contraindications or pathologies associated with exercise

Sponsors & Collaborators

• University of Oviedo: lead

Study Sites (1)

Hugo Olmedillas

Oviedo, Principality of Asturias, 33006, Spain

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Stress, Psychological; Sedentary Behavior; Motor Activity

Interventions

Masks

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 16, 2021
• Study Start: April 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)