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临床试验/NCT05561192
NCT05561192尚未招募不适用

Effects of Insertion of Diaphragmatic Breathing Exercises, Cardiorespiratory and Strength Exercises, and Cooperative Sports Activities During Physical Education Classes on Anxiety and Depression Symptoms in Adolescents

Federal University of Pelotas0 个研究点目标入组 320 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
320
主要终点
Change in Anxiety Symptoms

研究概览

简要总结

The main objective of this project will be to verify if the insertion of diaphragmatic, cardiorespiratory and strength breathing exercises and cooperative sports activities in Physical Education classes, during a period of 12 weeks, may be able to modify the scores of symptoms of anxiety and depression in adolescent students. As secondary objectives, this project will seek to verify which of the interventions will provide the greatest reductions in students' anxiety and depression symptoms, as well as analyze their effects on other health indicators, also verifying if a greater volume of sessions can provide additional benefits to mental health. when compared to a smaller volume. This is an experimental study, of the randomized clinical trial (RCT) type. The target population will be adolescent students (14 to 19 years old) from the Federal Institute Sul-rio-grandense (IFSul) on the Bagé and Pelotas campuses. A total of 16 classes will compose the sample. The classes that have the Physical Education (PE) curriculum component in their schedule will be listed and randomized in relation to the comparator group (CG) and to the three different intervention protocols: diaphragmatic breathing exercises (intervention group 1 or GI-1), physical exercises cardiorespiratory and strength activities (intervention group 2 or GI-2) and cooperative sports activities (intervention group 3 or GI-3). The application of these interventions will occur during PE classes, twice a week at Campus Bagé and three times a week at Campus Pelotas. Interventions will last 15 minutes in groups GI-1 and GI-2, and 20 minutes in GI-3. Before the start of the intervention, baseline assessments will be carried out, consisting of primary outcomes (symptoms of anxiety and depression) and secondary outcomes (self-concept, quality of life, sleep indicators, self-perception of physical fitness, cognitive failures, strength and cardiorespiratory fitness). The groups will be compared regarding the characteristics collected at baseline and after the 12th week of intervention. The Generalized Estimating Equations (GEE) and the post-hoc Bonferroni test will be used to compare the moments (pre and post-intervention) between the groups and to identify the group*moment interaction. Analyzes will be performed by protocol and by intention to treat. The significance coefficient adopted will be p<0.05.

详细描述

General objective To evaluate the effects of interventions with diaphragmatic breathing exercises, cardiorespiratory and strength exercises, and cooperative sports practices on anxiety and depression symptoms in adolescents during high school physical education classes.

Specific

  • To compare the effects of interventions with diaphragmatic breathing exercises, cardiorespiratory and strength exercises and cooperative sports practices on students' anxiety and depression symptoms;
  • Analyze the effect and compare the interventions carried out in relation to the different health indicators: Quality of life, Sleep indicators, Self-concept, Self-perception of physical fitness, Cognitive failures, Strength (maximum, resistance and power) and Cardiorespiratory fitness;
  • Verify and compare the effect of interventions with different weekly volumes (twice a week and three times a week) on students' anxiety and depression symptoms, as well as on the secondary outcomes analyzed.

Target Population and Sample The target population will be integrated high school students from the Federal Institutes of Rio Grande do Sul. The study sample will be composed of students (14 to 19 years old) of the integrated high school of the Federal Institutes of Sul-rio-grandense (IFSul) Campus Pelotas and Bagé.

Sample characterization variables demographic indicators

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Given the nature of this project, it will not be possible to blind the samples (classes) participating in the study due to the clarity of the intervention process (diaphragmatic breathing exercises, cardiorespiratory and strength exercises and cooperative sports activities) not even from teachers or external applicators. However, it is important to note that there will be blinding of the process within the following points:

  • Applicators of the instruments (questionnaires) and evaluators teachers, who will carry out the anthropometric evaluations of the subjects;
  • Tabulation and data analysis;

入排标准

年龄范围
14 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Students who are regularly enrolled and attending Physical Education classes at the integrated high school of IFSul Campus Bagé and Pelotas;

排除标准

  • Students under 14 years of age or over 19 years;
  • Students with any physical or health limitation that prevents the execution of practical activities, as well as those supported by a medical certificate;
  • Students who do not reach the minimum attendance of 75% in physical education classes;
  • Students who present a clinical diagnosis of anxiety or depression;
  • Students who use medication for anxiety or depression;
  • Students who are currently undergoing psychiatric or psychological follow-up or who have performed this professional follow-up in the last 12 months.

结局指标

主要结局

Change in Anxiety Symptoms

时间窗: Anxiety symptoms will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).

Anxiety symptoms will be assessed using the GAD-7 instrument. The instrument measurements range from 0 to 21 points, with values greater than 10 indicating anxiety symptoms.

Change in Depressive Symptoms

时间窗: Depressive symptoms will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).

Depressive symptoms will be assessed using the PHQ-9 instrument. The instrument measurements range from 0 to 27 points, with values greater than 10 indicating depressive symptoms.

次要结局

  • Change in Self-concept(Self-concept will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).)
  • Change in Quality of Life(Quality of life will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).)
  • Change in Sleep Indicators(Sleep indicators will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).)
  • Change in Self-perception of physical fitness(Self-perception of physical fitness will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).)
  • Change in Cognitive failures(Cognitive failures will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).)
  • Change in Endurance Strength(Endurance strength will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).)
  • Change in Cardiorespiratory Fitness(Cardiorespiratory Fitness will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).)
  • Change in Strength(Strength will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).)
  • Change in Power(Power will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).)

研究者

发起方
Federal University of Pelotas
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriel Gustavo Bergmann

Director

Federal University of Pelotas

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