Effects of Inserting Exercises During Physical Education Classes on Anxiety and Depression Symptoms in Adolescents

Depressive Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05561192
• Other study ID #: Int_IFSUL
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

• Gender identity;

• Age;

• Marital status;

• Skin color.

Socioeconomic indicators

• Socioeconomic level through monthly family income (BRL);

• Campus you study;

• Course and year/semester attended.

Anthropometric indicators

• Body mass (kilograms);

• Height (meters);

• Body Mass Index (BMI).

Clinical indicators

• Previous clinical diagnosis of anxiety or depression disorder in the student;

• History of any diagnosed anxiety disorder in the family (father/mother);

• History of any diagnosed depressive disorder in the family (father/mother);

• Use of continuous use of anxiolytic;

• Use of continuous use antidepressant;

• Need for psychological or psychiatric follow-up in the last 12 months;

• Current psychological or psychiatric follow-up.

Control variables

• Level of physical activity;

• Screen time;

• Habitual practice of physical activity.

Instruments Anxiety Symptoms: Anxiety symptoms will be collected using the General Anxiety Disorder-7 (GAD-7) instrument. The General Anxiety Disorder-7 (GAD-7) instrument seeks to assess and monitor anxiety symptoms.

Depressive symptoms: To assess depressive symptoms, the Patient Health Questionnaire-9 (PHQ-9) instrument will be used, which seeks to assess and monitor depressive symptoms.

Self-concept: This assessment will be obtained through the Multidimensional Self-Concept Scale (AF-5).

Quality of Life: For the assessment of quality of life, the instrument World Health Organization Quality of Life (WHOQOL) abbreviated version, proposed by the World Health Organization.

Self-perception of physical fitness: For the assessment the self-perception of physical fitness will be used the Physical Fitness Questionnaire (International Fitness Scale - IFIS).

Cognitive Failures: For the assessment the cognitive failures will be used the Cognitive Failures Questionnaire (CFQ).

Physical activity level: The instrument to measure physical activity will be the International Physical Activity Questionnaire (IPAQ), short version, proposed by the World Health Organization (WHO) and the Center for Disease Control and Prevention (CDC).

Screen time: The variable "sedentary screen time" during leisure will be evaluated by the time of hours per day in which the person uses television, computer, tablet, cell phone and video game, in the face of a posture that implies low energy expenditure , such as sitting or lying down.

Habitual practice of physical activity: This variable will be analyzed through simple questions, such as "Do you currently practice any type of physical activity regularly? If yes, describe which one(s)."; "Is this physical activity performed under the supervision of a professional (teacher/technician)?"; "Where do you practice this physical activity?"; "Do you participate in competitions with this physical activity?". The mentioned questions aim to investigate the habitual practice of physical activities, the type, presence of supervision, location and purpose of these practices.

Body Mass Index: The body mass index (BMI) will be calculated by the body mass (Kg) measured, divided by the height (in meters) squared.

Strength: The maximum muscular strength will be measured through the handgrip strength by a hydraulic dynamometer.

The power of lower limbs will be evaluated through the horizontal jump test.

Endurance strength will be measured by the 1-minute abdominal endurance test.

Cardiorespiratory fitness: Cardiorespiratory fitness will be assessed through the 20m back and forth test.

Demographic variables

To collect information regarding demographic variables, the respondent will be asked to do the following:

• Tick one of the options in the gender question.

• Fill in your current age in complete years;

• Tick one of the options in the marital status question;

• Tick one of the options in the skin color question.

Socioeconomic indicators

For the collection of information regarding the socioeconomic variables, the respondent will be asked the following:

• Fill in the total monthly family income (BRL);

• Fill in the campus where you study (Bagé or Pelotas);

• Fill in the year or semester of the course you are enrolled and attending. The courses are as follows: agriculture, information technology, visual communication, interior design, buildings, electromechanics, electronics, electrotechnical and chemistry.

Anthropometric indicators To verify the anthropometric indicators, measurements of body weight (in kg) and height (in cm) will be performed. Body weight will be obtained using a scale, and students will be instructed to wear light clothes and be barefoot. Height will be measured using a stadiometer attached to the aforementioned scale.

Clinical indicators Student or family history of anxiety or depression disorder (parent); The history of anxiety or depression disorder in the student or in the father and/or mother will be collected through a closed question in which it will be asked if the student has a clinical diagnosis of anxiety or depression disorder and if any family member (father/mother) is or has been diagnosed with some form of anxiety disorder or depressive disorder. If positive in any of the questions, specify which disorder.

Drug intake Continuous use drugs will be collected through a closed question in which the person will be asked if the person uses anxiolytic or antidepressant drugs of continuous use and, if so, the name of these drugs and the doses ingested.

Psychological or psychiatric support Two questions will be made available about the need for some psychological or psychiatric follow-up. The first addressing whether there was psychological or psychiatric follow-up in the last 12 months and the second whether this service is currently needed.

Data analysis Initially, the numerical variables will be analyzed in relation to the normality of their distributions using the Shapiro-Wilk test. The description of numerical variables will be performed by the mean and standard deviation (sd) or median and interquartile intervals. The description of the categorical variables will be performed by the absolute (n) and relative (%) frequencies. To compare the characterization variables between the groups, ANOVA and the chi-square test will be used for numerical and categorical variables, respectively. Generalized Estimating Equations (GEE) and Bonferroni's post-hoc test will be used to compare moments (pre and post-intervention) and between groups to identify the group*moment interaction. Analyzes will be performed by intention to treat and by protocol. In intention-to-treat analyses, all participants will be included. Participants who do not present consistent data in at least one of the moments (pre and/or post-intervention) and those students who present any of the aforementioned exclusion criteria will be removed from the protocol analyses. It will also be verified the effect size amplitude through Cohen's "d", obtaining the classification: insignificant (≤0.19) small (0.20 to 0.49); medium (0.50 to 0.79); large (0.80 to 1.29) and very large (≥1.30), according to Cohen (1988) and Rosenthal (1996). The significance level adopted will be 5% for all statistical analyses.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: December 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 19 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criterias:

• 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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Symptoms
• Depression
• Depressive Symptoms

Intervention

Other:
• Diaphragmatic breathing exercises
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.
• Cardiorespiratory and strength exercise
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".
• Cooperative sports activities 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.
• Traditional physical education class
The comparator group will take physical education classes normally, following the traditional menu in the discipline, without changes in the conduct of activities.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Pelotas

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	Change in Self-concept	This assessment will be obtained through the Multidimensional Self-Concept Scale (AF-5). The instrument consists of 24 items and the result will be verified through the sum of each of the answered items, and the higher the total score, the greater the assessment of self-concept.	Self-concept will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
Secondary	Change in Quality of Life	This assessment will be obtained through the WHOQoL (World Health Organization-Quality of Life- Brief). The instrument consists of 26 items. The results will be transformed into a linear scale, which may vary from 0 to 100, and the higher the result found, the greater the perception of quality of life of the subject.	Quality of life will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
Secondary	Change in Sleep Indicators	This assessment will be obtained through the Pittsburgh Sleep Quality Index (PSQI). The instrument consists of 19 self-administered questions. The results are obtained by a global score that varies from 0 to 21 points and the higher the score, the worse the sleep quality.	Sleep indicators will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
Secondary	Change in Self-perception of physical fitness	This assessment will be obtained through the International Fitness Scale - IFIS. The instrument consists of five questions, where higher scores indicate better self-perceptions of physical fitness.	Self-perception of physical fitness will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
Secondary	Change in Cognitive failures	This assessment will be obtained through the Questionnaire of Cognitive Flaws (QCF). The instrument consists of 25 questions, and the results are verified through the sum of each of the answered items, ranging from 0 to 100. High scores indicate greater behavioral errors caused by cognitive distortions.	Cognitive failures will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
Secondary	Change in Strength	This assessment will be obtained through the hand grip by a hydraulic dynamomete. The higher the values verified in the test, the greater strength.	Strength will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
Secondary	Change in Power	This assessment will be obtained through the Power of lower limbs will be evaluated through the horizontal jump test. The higher the values verified in the test, the greater power.	Power will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
Secondary	Change in Endurance Strength	This assessment will be obtained through the Endurance strength and will be measured by the 1-minute abdominal endurance test. The higher the values verified in the test, the greater endurance strength.	Endurance strength will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
Secondary	Change in Cardiorespiratory Fitness	This assessment will be obtained through the 20m back and forth test. The higher the values verified in the tests through the distance traveled, in meters, the greater the estimates of maximum oxygen consumption.	Cardiorespiratory Fitness will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).