NCT05879900

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 Canguçu/RS 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

May 6, 2023

Last Update Submit

May 18, 2023

Conditions

Keywords

Physical FitnessPhysical ActivitySchoolsPhysical Education and TrainingIntervention Study

Outcome Measures

Primary Outcomes (10)

  • Change in Cardiorespiratory Fitness

    Cardiorespiratory fitness (m) will be measured based on performance in the six-minute run/walk test.

    Cardiorespiratory Fitness will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).

  • Change in Muscular Strength/Endurance

    Muscle strength/endurance (rep/min) will be evaluated by the number of sit-ups performed in one minute.

    Muscular Strength/Endurance will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).

  • Change in Handgrip Strength

    The handgrip (kgf) strength will be evaluated by a handgrip dynamometer (Jamar®).

    Handgrip Strength will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).

  • Change in Lower Limb Power

    Lower Limb Power (cm) will be evaluated by the horizontal jump test.

    Lower limb power will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).

  • Change in Speed

    Speed (s) will be assessed by the twenty meters sprint running test.

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

  • Change in Agility

    Agility (s) will be assessed by the four by four meters square test.

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

  • Change in Flexibility

    Flexibility (cm) will be assessed by the sit and reach test.

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

  • Change in Body Mass Index

    Body Mass Index (kg/m2) will be calculated from the body mass (kg) and height (m) measures by the follow equation: body mass (kg) / height(m)2

    Body Mass Index will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).

  • Change in Waist Circunference

    Waist Circunference (cm) will be measure using a flexible measuring tape with millimeter resolution positioned at the midpoint between the last rib and the iliac crest according to standardized procedures.

    Waist Circunference will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).

  • Change in Sum of Triceps and Subscapular Skinfolds

    Triceps and Subscapular Skinfolds (mm) will be measured by folding a double thickness of skin and adjacent adipose tissue, with index finger and thumb the fold must be pinched to facilitate the measurement and position the plicometer reader upwards according to standardized procedures.

    Sum of Triceps and Subscapular Skinfolds will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).

Secondary Outcomes (6)

  • Changes in Physical Activity Level

    Physical Activity Level will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).

  • Changes in Recreational Screen Time

    Recreational Screen Time will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).

  • Changes in Sleep Time

    Sleep Time will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).

  • Changes in Physical Self-Concept

    Physical Self-Concept will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).

  • Changes in Motivation to Participate in Physical Education Classes

    Motivation to Participate in Physical Education Classes will be assessed at week 0 (pre-intervention) and week 13 (post-intervention).

  • +1 more secondary outcomes

Study Arms (2)

Intervention Group - IG

EXPERIMENTAL

The intervention group will have in their Physical Education classes the inclusion of functional physical exercises lasting approximately 15 minutes at the beginning of the classes. After the intervention, the classes will continue according their previously planned contents. Classes take place twice a week, on non-consecutive days. In this way, the intervention program will take place over 12 weeks, totaling 24 sessions distributed in 24 classes. The exercises will be performed with natural body movements such as running, jumping, jumping, pulling, crouching, turning and pushing in order to develop Physical Fitness. During the intervention program period there will be an increase in intensities and complexity going through processes that follow the initial, intermediate and final preparation and progression.

Other: Functional physical exercises

Comparator Group - CG

ACTIVE COMPARATOR

The comparator group wil keep performing the Physical Education classes according their previously planned contents.

Other: Physical Education classes

Interventions

Functional physical exercises lasting approximately 15 minutes, for 12 weeks or 24 sessions. The exercises take place during physical education classes taught by the physical education teachers in charge of the classes. The place of intervention takes place in full-time schools in the rural area.

Intervention Group - IG

Physical Education classes according their previously planned contents.

Comparator Group - CG

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Schoolchildren from the 6th to the 9th grade of both sexes;
  • Regularly enrolled in Full-time schools in the municipal public network of Canguçu/RS in the rural area;
  • Have teachers with academic training in the field of Physical Education

You may not qualify if:

  • Students who have disabilities or physical or cognitive limitations that prevent them from performing physical activities and/or compromise the answers to the questionnaires will be excluded from the study analysis. It is important to point out that if there is a student in this situation, they will participate normally in the intervention and measures (if they express their will and their guardians have consented), but their information will not be used.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Higher School of Physical Education - Federal University of Pelotas

Pelotas, Rio Grande do Sul, 96.055-630, Brazil

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Gabriel G Bergmann, PhD

    Escola Superior de Educação Física - Universidade Federal de Pelotas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The blinding process will only be in relation to the evaluators of the pre- and post-intervention variables and those responsible for the tabulation and data analysis. Regarding the blinding of the sample and teachers participating in the intervention, it will not be possible to blind the process of clarity and understanding of the intervention in which the group will participate.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The research methodology consists of 230 participants, of which 115 subjects will be the Control Group with interventions to be carried out: pre and post-intervention measures and the other 115 subjects will be the Intervention Group with interventions of pre- and post-intervention measures, and participation of the study intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 6, 2023

First Posted

May 30, 2023

Study Start

March 20, 2023

Primary Completion

July 30, 2023

Study Completion

December 31, 2023

Last Updated

May 30, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations