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临床试验/NCT04800848
NCT04800848已完成不适用

Effects of the N95/FFP2 Face Mask on Physical Fitness in Children

University of Oviedo1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
165
试验地点
1
主要终点
Horizontal Jump

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Horizontal Jump

时间窗: 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.

Height

时间窗: 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

时间窗: 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)

Physical Activity

时间窗: 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.

Emotional states

时间窗: 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.

Speed and agility

时间窗: 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.

Sedentarism

时间窗: 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.

Handgrip strength

时间窗: 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.

Aerobic capacity

时间窗: 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

时间窗: 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.

waist circumference

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hugo Olmedillas Fernandez

Associate Professor

University of Oviedo

研究点 (1)

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