Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05879900
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-30
First Post:
2023-05-06
Brief Title:
Effects of a Fifteen-minute Functional Exercise Intervention on Levels of Physical Fitness of Schoolchildren
Sponsor:
Federal University of Pelotas
Organization:
Federal University of Pelotas
Study Overview
Official Title:
Effects of a Fifteen-minute Functional Exercise Intervention on Levels of Physical Fitness of Schoolchildren
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an intervention research project with a pragmatic experimental design of the type Randomized Clinical Trial Schoolchildren from 6th to 9th grade of both genders adolescents must be in age group between 10 and 17 years old enrolled in public schools in the city of CanguçuRS in the rural zone full-time that have professors with academic training in the area of EF will be allocated in intervention group IG and control group CG The GI will participate in the inclusion of 15 minutes of functional exercises during the PE class and the GC will continue with the PE classes as planning elaborated by the teachers and pedagogical coordination The study variables will be organized into main dependents physical parameters related to health secondary dependents parameters behavioral and psychological health-related characterization of the participants and independent
After the 12 weeks of intervention the data will be collected again in order to compare the data obtained before the intervention The expected results after 12 weeks will be that the Group intervention has a significant improvement in the physical behavioral and psychosocial parameters of health compared to the control group
After the 12 weeks of intervention the data will be collected again in order to compare the data obtained before the intervention The expected results after 12 weeks will be that the Group intervention has a significant improvement in the physical behavioral and psychosocial parameters of health compared to the control group
Detailed Description:
1 OBJECTIVES
General
As a general objective to evaluate the effects of a fifteen-minute intervention of functional exercises during PE classes on physical behavioral and psychosocial health parameters in schoolchildren
Specific
Check the effects of the intervention with fifteen-minute functional exercises
In cardiorespiratory fitness
In strength endurance and muscle power
On speed and agility
On flexibility
On body mass index waist circumference and skinfolds
In physical activity levels
In recreational screen time
In self-concept
Motivation for participation in PE classes
In mental health symptoms of stress anxiety and depression
2 STUDY METHODOLOGY
The Study consists of 230 participants with 115 subjects being the Control Group GC with interventions to be carried out pre and post-intervention measures and the other 115 subjects will be the Intervention Group IG with interventions of pre- and post-intervention measures and participation of the study intervention
Contact was made with the management teams of the schools to present the study proposal as well as as the request for its realization in the dependencies of the schools With the authorization of SMEEC and directive teams the Physical Education teachers responsible for the schools in the final years of elementary school were contacted and the project objectives presented It was also explained that the teachers who make up the GI will participate in training to apply the training program intervention and that the teachers who make up the GC will be offered the same training at the end of the study In each EDUCCAN there is a Physical Education teacher
Thus among the teachers who expressed interest and consented to participate in the study all professors internal titular or external signed a Term of Free and Informed Consent TCLE signaling your acceptance to participate in the study
There was a simple raffle dividing them into groups that received training to apply the training program intervention before the beginning of the study teachers who composed the IG and after the end of the study teachers who may compose the GC
The teachers drawn to compose the GC were invited to participate in a training course on Sports Praxeology in the same period of formation of the GI After intervention the GI was invited to participate in training on Sports Praxeology and the GC in training on the functional exercise intervention Allocation of Groups The process of allocation of groups took place in the following way EDUCCANs Physical Education teachers graduated in PE who agreed to participate in the study were drawn to participate in training on the intervention program before the start of the study the teachers who made up the GI and after the end of the study teachers who made up the CG The teachers who were drawn to the GI participated in training on the intervention program before the start of the study and are responsible for carrying out the intervention activities of this project The students of classes in the final years of elementary school in the schools where these teachers work were invited to participate in the intervention GC teachers participated in training on Praxeology Sports and were instructed to keep their classes according to the planning previously carried out by them following the SMEEC guidelines It is noteworthy that the GC professors will be invited to participate in the same IG training after the end of the intervention period
The number of teachers who had their classes evaluated participating in the study was defined according to the number of students enrolled per school where these teachers work Thus among teachers who agreed to participate in the study a simple drawing was carried out Initially a teacher was drawn who participated in the training GI and the number of students enrolled in the school where this teacher teaches The number of drawn teachers was defined considering the estimated number of students to compose the IG and GC according to the sample size calculation The same procedure was carried out in relation to the teachers who participated in the training only after the completion of the study and therefore it will be the teachers of the classes that will form the GC
The training of school teachers EDUCCAN was conducted by the teachers responsible for project and was carried out in a hybrid and face-to-face manner The teachers that intervention applicators are physical education teachers trained in the area and full professors of the classes The pre- and post-intervention measures are carried out by an evaluation team made up of students and professors from the field of physical education The evaluation team went through face-to-face theoretical-practical training on the procedures and standardization for applying the evaluative instruments aimed at pre and post intervention tests
The variables and measurement procedures of the study were organized into main dependents physical parameters related to health secondary behavioral and psychological parameters related to health characterization of participants and independent Main Dependent Variables The physical parameters related to the analyzed will be Anthropometric Indicators Cardiorespiratory Fitness APC StrengthEndurance Muscle FRM Handgrip Strength Power of Lower Limbs Speed Agility and Flexibility FLEX Anthropometric Indicators The anthropometric indicators analyzed will be the height cm body mass kg waist circumference cm sitting height cm and skinfolds triceps and subscapular skin mm
The evaluations will be carried out using the classroom space during one of the Education classes Physics of selected schools The teachers accompanied by the team of evaluators responsible application they must complete the instrument Questionnaire by themselves requesting support in case of doubt Anthropometric measurements and physical fitness tests were also applied in the week before the interventions using a second moment of one of the disciplines classes To the height and body mass measurements will be carried out in a reserved room made available by the directions of schools Physical fitness tests will be carried out in the space intended for Education classes Physics from both schools That same week in the classroom a familiarization will be proposed in in relation to the subjective perception of Borg Effort scale for students belonging to the intervention with functional cardiorespiratory and strength exercises Finally the collections will be carried out again in both schools in the subsequent week after the end of the interventions using the same logistics of the initial data collection Description of the intervention Intervention Group IG Students who composing the intervention group will have in their PE classes the inclusion of functional physical exercises about 15 minutes of class After the intervention the classes continue with their pre-planned content At EDUCCAN there are three PE periodsclasses per week with 50 minutes long each
The structuring comprises a 12-week intervention or 24 classes
3 STATISTICAL ANALYSIS
The data will be double typed in the EpiData 31 software exported and analyzed using the statistical package SPSS version 200 Initially 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 mean x and standard deviation sd or median and interquartile differences The description of categorical variables will be carried out by absolute n and relative frequencies
To compare the characterization variables between the groups the t test for independent samples and the chi-square test for numerical and categorical variables respectively will be used Generalized Estimating Equations GEE and Bonferronis post-hoc test will be used to compare time points pre and post-intervention between groups and to identify the grouptime interaction
The amplitude of the effect sizes will be verified through Cohens d obtaining the classification small effect size 020 to 049 medium 050 to 079 large 080 to 129 very large 130 according to ROSENTHAL 1996
Analyzes will be performed by intention to treat and by protocol In intention-to-treat analyses all participants will be included In the analyzes per protocol participants who did not present consistent data in at least one of the moments pre andor post-intervention and those who did not participate in at least 75 of the classes will be removed The significance level adopted will be 5 for all statistical analyses
4 ETHICAL ASPECTS
By complying with the ethical requirements of the research the project was qualified and the necessary adjustments were made as suggested by the opinion of the qualification board later it was submitted via Plataforma Brasil to the Ethics Committee in Research for Human Beings of the Higher School of Physical Education of the Federal University of Pelotas ESEFUFPel and approved according to protocol 66152922700005313 following all ethical principles involving human beings to carry out this study
The participants parents andor legal guardians were duly informed about the objectives and procedures of the study through the Free and Informed Assent Term TALE of the minor signed by the students participating in the research and the legal guardians of the students signed the Free Consent Term and Clarified TCLE The secrecy of the data collected in this study is kept absolutely reserved and used only for research purposes
As for the risks of the intervention participants they are minimal as they are the same physical risks routinely encountered by students in physical education classes
The activities will only be carried out by students who do not have physical or health limitations that could prevent physical activities Any intercurrence of any risk to the student will be attended initially by the teacher in charge in case of an emergency service the Mobile Emergency Service System SAMU will be activated by contact phone 192 After the intervention the student does not feel comfortable and wants to stop participating in the study
General
As a general objective to evaluate the effects of a fifteen-minute intervention of functional exercises during PE classes on physical behavioral and psychosocial health parameters in schoolchildren
Specific
Check the effects of the intervention with fifteen-minute functional exercises
In cardiorespiratory fitness
In strength endurance and muscle power
On speed and agility
On flexibility
On body mass index waist circumference and skinfolds
In physical activity levels
In recreational screen time
In self-concept
Motivation for participation in PE classes
In mental health symptoms of stress anxiety and depression
2 STUDY METHODOLOGY
The Study consists of 230 participants with 115 subjects being the Control Group GC with interventions to be carried out pre and post-intervention measures and the other 115 subjects will be the Intervention Group IG with interventions of pre- and post-intervention measures and participation of the study intervention
Contact was made with the management teams of the schools to present the study proposal as well as as the request for its realization in the dependencies of the schools With the authorization of SMEEC and directive teams the Physical Education teachers responsible for the schools in the final years of elementary school were contacted and the project objectives presented It was also explained that the teachers who make up the GI will participate in training to apply the training program intervention and that the teachers who make up the GC will be offered the same training at the end of the study In each EDUCCAN there is a Physical Education teacher
Thus among the teachers who expressed interest and consented to participate in the study all professors internal titular or external signed a Term of Free and Informed Consent TCLE signaling your acceptance to participate in the study
There was a simple raffle dividing them into groups that received training to apply the training program intervention before the beginning of the study teachers who composed the IG and after the end of the study teachers who may compose the GC
The teachers drawn to compose the GC were invited to participate in a training course on Sports Praxeology in the same period of formation of the GI After intervention the GI was invited to participate in training on Sports Praxeology and the GC in training on the functional exercise intervention Allocation of Groups The process of allocation of groups took place in the following way EDUCCANs Physical Education teachers graduated in PE who agreed to participate in the study were drawn to participate in training on the intervention program before the start of the study the teachers who made up the GI and after the end of the study teachers who made up the CG The teachers who were drawn to the GI participated in training on the intervention program before the start of the study and are responsible for carrying out the intervention activities of this project The students of classes in the final years of elementary school in the schools where these teachers work were invited to participate in the intervention GC teachers participated in training on Praxeology Sports and were instructed to keep their classes according to the planning previously carried out by them following the SMEEC guidelines It is noteworthy that the GC professors will be invited to participate in the same IG training after the end of the intervention period
The number of teachers who had their classes evaluated participating in the study was defined according to the number of students enrolled per school where these teachers work Thus among teachers who agreed to participate in the study a simple drawing was carried out Initially a teacher was drawn who participated in the training GI and the number of students enrolled in the school where this teacher teaches The number of drawn teachers was defined considering the estimated number of students to compose the IG and GC according to the sample size calculation The same procedure was carried out in relation to the teachers who participated in the training only after the completion of the study and therefore it will be the teachers of the classes that will form the GC
The training of school teachers EDUCCAN was conducted by the teachers responsible for project and was carried out in a hybrid and face-to-face manner The teachers that intervention applicators are physical education teachers trained in the area and full professors of the classes The pre- and post-intervention measures are carried out by an evaluation team made up of students and professors from the field of physical education The evaluation team went through face-to-face theoretical-practical training on the procedures and standardization for applying the evaluative instruments aimed at pre and post intervention tests
The variables and measurement procedures of the study were organized into main dependents physical parameters related to health secondary behavioral and psychological parameters related to health characterization of participants and independent Main Dependent Variables The physical parameters related to the analyzed will be Anthropometric Indicators Cardiorespiratory Fitness APC StrengthEndurance Muscle FRM Handgrip Strength Power of Lower Limbs Speed Agility and Flexibility FLEX Anthropometric Indicators The anthropometric indicators analyzed will be the height cm body mass kg waist circumference cm sitting height cm and skinfolds triceps and subscapular skin mm
The evaluations will be carried out using the classroom space during one of the Education classes Physics of selected schools The teachers accompanied by the team of evaluators responsible application they must complete the instrument Questionnaire by themselves requesting support in case of doubt Anthropometric measurements and physical fitness tests were also applied in the week before the interventions using a second moment of one of the disciplines classes To the height and body mass measurements will be carried out in a reserved room made available by the directions of schools Physical fitness tests will be carried out in the space intended for Education classes Physics from both schools That same week in the classroom a familiarization will be proposed in in relation to the subjective perception of Borg Effort scale for students belonging to the intervention with functional cardiorespiratory and strength exercises Finally the collections will be carried out again in both schools in the subsequent week after the end of the interventions using the same logistics of the initial data collection Description of the intervention Intervention Group IG Students who composing the intervention group will have in their PE classes the inclusion of functional physical exercises about 15 minutes of class After the intervention the classes continue with their pre-planned content At EDUCCAN there are three PE periodsclasses per week with 50 minutes long each
The structuring comprises a 12-week intervention or 24 classes
3 STATISTICAL ANALYSIS
The data will be double typed in the EpiData 31 software exported and analyzed using the statistical package SPSS version 200 Initially 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 mean x and standard deviation sd or median and interquartile differences The description of categorical variables will be carried out by absolute n and relative frequencies
To compare the characterization variables between the groups the t test for independent samples and the chi-square test for numerical and categorical variables respectively will be used Generalized Estimating Equations GEE and Bonferronis post-hoc test will be used to compare time points pre and post-intervention between groups and to identify the grouptime interaction
The amplitude of the effect sizes will be verified through Cohens d obtaining the classification small effect size 020 to 049 medium 050 to 079 large 080 to 129 very large 130 according to ROSENTHAL 1996
Analyzes will be performed by intention to treat and by protocol In intention-to-treat analyses all participants will be included In the analyzes per protocol participants who did not present consistent data in at least one of the moments pre andor post-intervention and those who did not participate in at least 75 of the classes will be removed The significance level adopted will be 5 for all statistical analyses
4 ETHICAL ASPECTS
By complying with the ethical requirements of the research the project was qualified and the necessary adjustments were made as suggested by the opinion of the qualification board later it was submitted via Plataforma Brasil to the Ethics Committee in Research for Human Beings of the Higher School of Physical Education of the Federal University of Pelotas ESEFUFPel and approved according to protocol 66152922700005313 following all ethical principles involving human beings to carry out this study
The participants parents andor legal guardians were duly informed about the objectives and procedures of the study through the Free and Informed Assent Term TALE of the minor signed by the students participating in the research and the legal guardians of the students signed the Free Consent Term and Clarified TCLE The secrecy of the data collected in this study is kept absolutely reserved and used only for research purposes
As for the risks of the intervention participants they are minimal as they are the same physical risks routinely encountered by students in physical education classes
The activities will only be carried out by students who do not have physical or health limitations that could prevent physical activities Any intercurrence of any risk to the student will be attended initially by the teacher in charge in case of an emergency service the Mobile Emergency Service System SAMU will be activated by contact phone 192 After the intervention the student does not feel comfortable and wants to stop participating in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None