Depressive SymptomsNCT05561192
Effects of Inserting Exercises During Physical Education Classes on Anxiety and Depression Symptoms in Adolescents
A study testing Diaphragmatic breathing exercises, Cardiorespiratory and strength exercise and Cooperative sports activities group in people with Depressive Symptoms and Anxiety Symptoms, run by Federal University of Pelotas.
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… Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Anxiety Symptoms
- What is being tested?
- Diaphragmatic breathing exercises, Cardiorespiratory and strength exercise and Cooperative sports activities group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Students who are regularly enrolled and attending Physical Education classes at the integrated high school of IFSul Campus Bagé and Pelotas;
Who cannot join
- 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.
About this study
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
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.
Read the detailed 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.
- Conditions
- Depressive Symptoms, Anxiety Symptoms
- Being tested
- Diaphragmatic breathing exercises, Cardiorespiratory and strength exercise, Cooperative sports activities group, Traditional physical education class
- Keywords
- depressive symptoms, anxiety symptoms, physical education, school, intervention, breathing exercises, physical exercises, cooperative sports activities
- Medical subject headings
- Depression, Anxiety Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic breathing exercisesOther
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 exerciseOther
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 groupOther
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 classOther
The comparator group will take physical education classes normally, following the traditional menu in the discipline, without changes in the conduct of activities.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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?). Receives: 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. Receives: Other: Traditional physical education class |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Anxiety symptoms will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
Secondary outcomes (9)
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.
Measured: Self-concept will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
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.
Measured: Quality of life will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
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.
Measured: Sleep indicators will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
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.
Measured: Self-perception of physical fitness will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
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.
Measured: Cognitive failures will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
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.
Measured: Strength will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
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.
Measured: Power will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
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.
Measured: Endurance strength will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
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.
Measured: Cardiorespiratory Fitness will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start1 Feb 2023 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Gustavo Bergmann, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561192
- Sponsor's protocol ID
- Int_IFSUL
- Status last verified
- Sep 2022
- First submitted
- 23 Aug 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
ASHDOWN-FRANKS, G.; SABISTON, C.M.; SOLOMON-KRAKUS, S.; O'LOUGHLIN, J.L. Sport participation in high school and anxiety symptoms in young adulthood. Ment Health Phys Act. 2017;12:19-24.
Bordoni B, Purgol S, Bizzarri A, Modica M, Morabito B. The Influence of Breathing on the Central Nervous System. Cureus. 2018 Jun 1;10(6):e2724. doi: 10.7759/cureus.2724.
PubMed 30083485Broadbent DE, Cooper PF, FitzGerald P, Parkes KR. The Cognitive Failures Questionnaire (CFQ) and its correlates. Br J Clin Psychol. 1982 Feb;21(1):1-16. doi: 10.1111/j.2044-8260.1982.tb01421.x.
PubMed 7126941Busch V, Magerl W, Kern U, Haas J, Hajak G, Eichhammer P. The effect of deep and slow breathing on pain perception, autonomic activity, and mood processing--an experimental study. Pain Med. 2012 Feb;13(2):215-28. doi: 10.1111/j.1526-4637.2011.01243.x. Epub 2011 Sep 21.
PubMed 21939499Chen YF, Huang XY, Chien CH, Cheng JF. The Effectiveness of Diaphragmatic Breathing Relaxation Training for Reducing Anxiety. Perspect Psychiatr Care. 2017 Oct;53(4):329-336. doi: 10.1111/ppc.12184. Epub 2016 Aug 23.
PubMed 27553981Cole TJ, Lobstein T. Extended international (IOTF) body mass index cut-offs for thinness, overweight and obesity. Pediatr Obes. 2012 Aug;7(4):284-94. doi: 10.1111/j.2047-6310.2012.00064.x. Epub 2012 Jun 19.
PubMed 22715120FERNÁNDEZ-RÍO, J. Another step in models-based practice: Hybridizing Cooperative Learning and Teaching for Personal and Social Responsibility. J Phys Educ Recreat Danc. 2014;85(7):3-5.
FERNÁNDEZ-RIO, J.M.; MÉNDEZ-GIMÉNEZ, A. El Aprendizaje Cooperativo: Modelo Pedagógico para Educación Física (Cooperative learning: Pedagogical Model for Physical Education). Retos. 2016;2041(29):201-6.
FERNÁNDEZ-RIO, J.; CALDERÓN, A.; HORTIGÜELA ALCALÁ, D.; PÉREZ PUEYO, Á.; AZNAR CEBAMANOS, M. Modelos pedagógicos en Educación Física: consideraciones teórico-prácticas para docentes. Rev Española Educ Física y Deport REEFD. 2016;(413):55-75.
Fleck MP, Louzada S, Xavier M, Chachamovich E, Vieira G, Santos L, Pinzon V. [Application of the Portuguese version of the abbreviated instrument of quality life WHOQOL-bref]. Rev Saude Publica. 2000 Apr;34(2):178-83. doi: 10.1590/s0034-89102000000200012. Portuguese.
PubMed 10881154Foster C. Monitoring training in athletes with reference to overtraining syndrome. Med Sci Sports Exerc. 1998 Jul;30(7):1164-8. doi: 10.1097/00005768-199807000-00023.
PubMed 9662690GARCÍA, F.; MUSITU, G. Manual Af-5. Autoconcepto forma 5. Madrid: TEA; 2014.
Gomez-Baya D, Calmeiro L, Gaspar T, Marques A, Loureiro N, Peralta M, Mendoza R, Gaspar de Matos M. Longitudinal Association between Sport Participation and Depressive Symptoms after a Two-Year Follow-Up in Mid-Adolescence. Int J Environ Res Public Health. 2020 Oct 14;17(20):7469. doi: 10.3390/ijerph17207469.
PubMed 33066534Heijnen S, Hommel B, Kibele A, Colzato LS. Neuromodulation of Aerobic Exercise-A Review. Front Psychol. 2016 Jan 7;6:1890. doi: 10.3389/fpsyg.2015.01890. eCollection 2015.
PubMed 26779053Kraemer WJ, Ratamess NA. Fundamentals of resistance training: progression and exercise prescription. Med Sci Sports Exerc. 2004 Apr;36(4):674-88. doi: 10.1249/01.mss.0000121945.36635.61.
PubMed 15064596
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05561192
- Acronym / sponsor ID
- Int_IFSUL
- Conditions
- Depressive Symptoms, Anxiety Symptoms
- Keywords
- depressive symptoms, anxiety symptoms, physical education, school, intervention, breathing exercises, physical exercises, cooperative sports activities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| diaphragmatic breathing exercises group | Experimental | Other: Diaphragmatic breathing exercisesIntervention 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. |
| Cardiorespiratory and strength exercise group | Experimental | Other: Cardiorespiratory and strength exerciseIntervention 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. |
| Cooperative sports activities group | Experimental | Other: Cooperative sports activities groupThe 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?). |
| Comparator Group | Active comparator | Other: Traditional physical education classThe 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. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Students who are regularly enrolled and attending Physical Education classes at the integrated high school of IFSul Campus Bagé and Pelotas;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragmatic breathing exercisesThe 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. | Other | diaphragmatic breathing exercises group |
| Cardiorespiratory and strength exerciseDuring 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". | Other | Cardiorespiratory and strength exercise group |
| Cooperative sports activities groupIntervention 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. | Other | Cooperative sports activities group |
| Traditional physical education classThe comparator group will take physical education classes normally, following the traditional menu in the discipline, without changes in the conduct of activities. | Other | Comparator Group |
Primary outcome
Change in Depressive Symptoms
Time frame: 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.
Change in Anxiety Symptoms
Time frame: 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.
9 secondary outcomes
Change in Self-concept
Time frame: Self-concept will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
Change in Quality of Life
Time frame: Quality of life will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
Change in Sleep Indicators
Time frame: Sleep indicators will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
Change in Self-perception of physical fitness
Time frame: Self-perception of physical fitness will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
Change in Cognitive failures
Time frame: Cognitive failures will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
Change in Strength
Time frame: Strength will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
Change in Power
Time frame: Power will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
Change in Endurance Strength
Time frame: Endurance strength will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
Change in Cardiorespiratory Fitness
Time frame: Cardiorespiratory Fitness will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- BackgroundASHDOWN-FRANKS, G.; SABISTON, C.M.; SOLOMON-KRAKUS, S.; O'LOUGHLIN, J.L. Sport participation in high school and anxiety symptoms in young adulthood. Ment Health Phys Act. 2017;12:19-24.
- Background: PubMed 30083485Bordoni B, Purgol S, Bizzarri A, Modica M, Morabito B. The Influence of Breathing on the Central Nervous System. Cureus. 2018 Jun 1;10(6):e2724. doi: 10.7759/cureus.2724.
- Background: PubMed 7126941Broadbent DE, Cooper PF, FitzGerald P, Parkes KR. The Cognitive Failures Questionnaire (CFQ) and its correlates. Br J Clin Psychol. 1982 Feb;21(1):1-16. doi: 10.1111/j.2044-8260.1982.tb01421.x.
- Background: PubMed 21939499Busch V, Magerl W, Kern U, Haas J, Hajak G, Eichhammer P. The effect of deep and slow breathing on pain perception, autonomic activity, and mood processing--an experimental study. Pain Med. 2012 Feb;13(2):215-28. doi: 10.1111/j.1526-4637.2011.01243.x. Epub 2011 Sep 21.
- Background: PubMed 27553981Chen YF, Huang XY, Chien CH, Cheng JF. The Effectiveness of Diaphragmatic Breathing Relaxation Training for Reducing Anxiety. Perspect Psychiatr Care. 2017 Oct;53(4):329-336. doi: 10.1111/ppc.12184. Epub 2016 Aug 23.
- Background: PubMed 22715120Cole TJ, Lobstein T. Extended international (IOTF) body mass index cut-offs for thinness, overweight and obesity. Pediatr Obes. 2012 Aug;7(4):284-94. doi: 10.1111/j.2047-6310.2012.00064.x. Epub 2012 Jun 19.
- BackgroundFERNÁNDEZ-RÍO, J. Another step in models-based practice: Hybridizing Cooperative Learning and Teaching for Personal and Social Responsibility. J Phys Educ Recreat Danc. 2014;85(7):3-5.
- BackgroundFERNÁNDEZ-RIO, J.M.; MÉNDEZ-GIMÉNEZ, A. El Aprendizaje Cooperativo: Modelo Pedagógico para Educación Física (Cooperative learning: Pedagogical Model for Physical Education). Retos. 2016;2041(29):201-6.
- BackgroundFERNÁNDEZ-RIO, J.; CALDERÓN, A.; HORTIGÜELA ALCALÁ, D.; PÉREZ PUEYO, Á.; AZNAR CEBAMANOS, M. Modelos pedagógicos en Educación Física: consideraciones teórico-prácticas para docentes. Rev Española Educ Física y Deport REEFD. 2016;(413):55-75.
- Background: PubMed 10881154Fleck MP, Louzada S, Xavier M, Chachamovich E, Vieira G, Santos L, Pinzon V. [Application of the Portuguese version of the abbreviated instrument of quality life WHOQOL-bref]. Rev Saude Publica. 2000 Apr;34(2):178-83. doi: 10.1590/s0034-89102000000200012. Portuguese.
- Background: PubMed 9662690Foster C. Monitoring training in athletes with reference to overtraining syndrome. Med Sci Sports Exerc. 1998 Jul;30(7):1164-8. doi: 10.1097/00005768-199807000-00023.
- BackgroundGARCÍA, F.; MUSITU, G. Manual Af-5. Autoconcepto forma 5. Madrid: TEA; 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic breathing exercises, Cardiorespiratory and strength exercise and Cooperative sports activities group in people with Depressive Symptoms and Anxiety Symptoms, run by Federal University of Pelotas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depressive Symptoms (time frame: Depressive symptoms will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05561192, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.