NCT05561192

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

August 23, 2022

Last Update Submit

September 26, 2022

Conditions

Keywords

depressive symptomsanxiety symptomsphysical educationschoolinterventionbreathing exercisesphysical exercisescooperative sports activities

Outcome Measures

Primary Outcomes (2)

  • Change in Depressive Symptoms

    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.

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

  • Change in Anxiety Symptoms

    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.

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

Secondary Outcomes (9)

  • 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).

  • +4 more secondary outcomes

Study Arms (4)

diaphragmatic breathing exercises group

EXPERIMENTAL

Intervention with diaphragmatic breathing exercises will take place in the last 15 minutes of Physical Education classes, focusing on diaphragmatic breathing. This breathing is also characterized by reducing the respiratory cycle or rate, and it can use the count of seconds in a progressive way, either in the inhalation through the nose while the abdomen expands, in the support or blockage or also called pause, and finally in the expiration, also performed by the nostrils. The creation of an inhalation and exhalation pattern becomes important as it has a direct relationship with the reduction of the activities of the sympathetic nervous system and the increase of the activity of the parasympathetic nervous system, also influencing the motor activities, the brain mass, the quality of the sleep and the attenuation of stressors.

Other: Diaphragmatic breathing exercises

Cardiorespiratory and strength exercise group

EXPERIMENTAL

Intervention with cardiorespiratory and strength physical exercises will always occur in the first 15 minutes of each class. Cardiorespiratory exercises and localized muscular resistance will be developed involving all muscle groups, adapted to the materials and school equipment available. The exercises developed will be primarily calisthenics, to facilitate a possible replication within the school environment. A circuit with 4 stations will be elaborated, where one station will offer a cardiorespiratory stimulus, containing the following exercises: jumping jacks, jumping rope, stationary running, going up and down steps and burpees. The other three stations will be composed of localized muscular resistance exercises, involving lower limbs (squat, lunge and isometric chair), upper limbs (flexion) and trunk (abdominal). The time of execution of the exercises in each station will be of 1 minute.

Other: Cardiorespiratory and strength exercise

Cooperative sports activities group

EXPERIMENTAL

The intervention of cooperative sports activities that will integrate the physical education class will be based on the cooperative learning model and elaborated through the aforementioned points. Intervention sessions will last 20 minutes, being held during the main part of the class. Activities will be planned that prioritize reflection, thinking and sharing of ideas among students, by proposing challenges within the sport. For example, how to get out of a certain type of marking within a game, or in the case of cooperative games, with the principle that students cooperate with each other to solve a proposed challenge (for example, how long a team can remain dominating the volleyball without it falling to the ground?).

Other: Cooperative sports activities group

Comparator Group

ACTIVE COMPARATOR

The classes that will form the comparator group will carry out the Physical Education classes according to the planning previously prepared by the professors of the discipline and that are already part of the syllabus of the semester and/or the school year of the classes. These contents, within the proposal of the two schools, are already consolidated and are centered on the teaching of sport through methodologies aimed at a pedagogical proposal mostly analytical, partial or characterized by the traditional model (technicist model). In these classes, the activities are practiced through the model of direct instruction of teaching, where the teacher acts as the main figure of the teaching-learning process.

Other: Traditional physical education class

Interventions

The initial proposal is for the first week to be adaptive, that is, learning to perform the exercises freely. During this period, students will be able to experience the activities and solve any doubts, as well as understand the process of a respiratory cycle, in which they will be initiated through a cycle of 12 times per minute. In the second and third weeks, the exercises will consist of 10 breathing cycles per minute (complete cycle consisting of 6 seconds, 2:2:2). It is important to note that each cycle contains the inspiration time, brief pause and expiration time in seconds. In the last week, each cycle will last 16 seconds, consisting of 4 seconds of inspiration, 4 seconds of pause and 8 seconds of expiration (4:4:8). Thus, the objective is to reduce the number of respiratory cycles per minute, as the intervention progresses.

diaphragmatic breathing exercises group

During the first two weeks, students will complete two laps of the circuit, with a 15-second break between one station and another and a 1-minute break between one lap and another. These first two weeks will focus on adaptation and technical learning of the exercises to be performed. From the third to the sixth week, one lap will be added to the circuit, totaling three laps, maintaining the aforementioned intervals. From week 7 to week 12, progressions will be carried out, reducing the interval time between one lap and another on the circuit to 30 seconds. For the purpose of controlling the intensity of the exercise, a subjective perception of effort scale will be used, composed of values from 1 to 10, the first being equivalent to "very light" effort activity, and ten, equivalent to "maximum effort activity".

Cardiorespiratory and strength exercise group

Intervention with cooperative sports activities will be based on the pedagogical model for teaching sports called "Cooperative Learning" or "Cooperative Learning". This pedagogical model has some predominant characteristics, such as student learning occurring with and through other students, through an approach that facilitates and enhances positive interdependence, where teachers and students act as co-learners. Thus, this teaching model encompasses two key points of cooperative learning: promoting interaction between students and interaction between students and teachers. Also, in the planning of intervention classes with sports, the five points described as fundamental for learning to be considered cooperative will be considered. These are: face-to-face interaction, positive interdependence, individual responsibility, group processing, and social skills.

Cooperative sports activities group

The comparator group will take physical education classes normally, following the traditional menu in the discipline, without changes in the conduct of activities.

Comparator Group

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (27)

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    BACKGROUND
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    PMID: 9662690BACKGROUND
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    BACKGROUND
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    PMID: 33066534BACKGROUND
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    PMID: 26779053BACKGROUND
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    PMID: 15064596BACKGROUND
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    PMID: 11556941BACKGROUND
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MeSH Terms

Conditions

DepressionAnxiety DisordersMotor Activity

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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;
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 23, 2022

First Posted

September 30, 2022

Study Start

February 1, 2023

Primary Completion

July 31, 2023

Study Completion

December 31, 2023

Last Updated

September 30, 2022

Record last verified: 2022-09