An interventional study of High-intensity intermittent games and Moderate intensity games in Children, Physical Activity, sponsored by Grupo Lusófona. Status unknown at 1 site in Chile. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-19.
Sponsored by Grupo Lusófona · Not applicable, Interventional, and Prevention
Among 53 studies in Motor Activity with a site in Chile — 16 open to participants now, 19 under way, none of them phase 3. Motor Activity · Chile.
Among the 53 studies in Motor Activity with a site in Chile, this one is the 29th largest by planned enrollment of the 49 interventional ones that give a count, is the only one that started in 2017, is one of 48 with no phase, and was the 4th registered.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
Browse Motor Activity studies →16 of the 53 studies in Motor Activity with a site in Chile are open now. Recruiting first, the newest first:
University of Chile · Sites in Chile
Universidad San Sebastián · Sites in Chile
Pontificia Universidad Catolica de Chile · Sites in Chile
University of Chile · Sites in Chile
Universidad de La Frontera · Sites in Chile
A study can be open while its sites in Chile have not opened yet or have stopped. Only those recruiting at a site in Chile →
Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.
This study: 8 Years to 12 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
53 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 1 started in 2017.
This study's planned enrollment of 54 is close to the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Median enrollment 60 across the 49 interventional studies, 1,434 across the 4 observational. Of the 26 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 53 has an industry lead sponsor. The 10 most frequent:
Grupo Lusófona is the lead sponsor of 10 studies on the registry; 5 are open to participants now.
Grupo Lusófona has 5 studies filed under Motor Activity — fewer than ten, so there is no comparison to draw.
3 of the studies in Motor Activity with a site in Chile that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06698367Universidad Catolica de TemucoUnilateral Training of the Uninjured Limb on Clinical Outcomes in Patients with Surgically Treated Radius Fracture | 2026-12 |
| NCT07552727Universidad San SebastiánRehabilitation With Exercise-Based Intervention for Nonalcoholic Chronic Hepatic Esteatosis | 2026-12-31 |
| NCT07633392University of ChileEffectiveness and Implementation Evaluation of NeoMayor for Improving Cardiovascular Health in Chilean Older Adults | 2027-04 |
Among the 53 studies in Motor Activity with a site in Chile, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study will assess the effectiveness of a high-intensity intermittent games intervention (HIIG) on cardiorespiratory fitness and corporal composition. Fifty-four children, aged 9-12 years, will be randomised into an HIIG or moderate-intensity games (MIG) group. Before and after the intervention, participants complete cardiorespiratory fitness and corporal composition test. The hypothesis states that there is an improvement in the cardiorespiratory fitness and in the body composition implementing high-intensity intermittent games.
Background
Physical activity is associated with many health benefits, but most children fail to meet the international recommendation. This is a concerning matter for the future health-care population, as cardio-metabolic risk factors in children and adolescents can lead to coronary heart disease, metabolic diseases (obesity, type II diabetes) and mortality in adulthood.
According to children participated in different types of physical activity or early sports practice in the first stages of life has been positively associated with lower occurrence of chronic diseases in adulthood. Ultimately, daily participation in outdoor games, fitness activities, and recreational sports will be a major factor in the improvement of health and well-being of children and adolescents.
Unlike adults, children's habitual physical activity patterns are highly intermittent in nature, characterised by rapid changes from rest to vigorous physical activity.
High-intensity intermittent training (HIIT) describes physical exercise as a brief, intermittent burst of vigorous activity, interspersed by rest periods or low-intensity exercise. HIIT offers infinite variations with the specific physiological adaptations induced by this form of training determined by several factors including the precise nature of the exercise stimulus. In recent years HIIT has received great scientific interest, the studies have examined the physiological effects of HIIT in children and adolescents and reported positive findings on cardiorespiratory fitness, fat-free mass index, a change in body mass index (BMI) and percentage body fat.
Objective The objective of the study is to verify the effects of a high-intensity intermittent games intervention (HIIG) versus a moderate intensity group on cardiorespiratory fitness and body composition in children. The hypotheses formulated was: high-intensity intermittent games intervention contribute to the improvement cardiorespiratory fitness and body composition in children.
Methods
Study Setting This study is performed in a public school setting in the city of Valparaiso, Chile.
Participants timeline Will be recruited through information to the parents 54 children from 8 to 12 years old belonging to a public school of Valparaiso, Chile.
Interventions The intervention will last for 12-weeks, each group included participation in twice-week 40 minutes exercise sessions. In HIIG children took part in 5 games per session; 2 velocity games and 3 small-sided games (such 3 vs 3 and 4 vs 4). This session included 4 minutes games and 2 minutes recovery. In MIG children took part in 5 games per session. This session included 4 minutes games and 3 minutes recovery. A standardised warm-up protocol consisting of 5 minutes of running and stretching is performed before each training session. Cool down is after class 5 minutes of static stretching.
The intensity will be continuously monitored during each session through heart rate (Polar M400, Finland) and rating of perceived exertion (RPE). The intervention will be based on the protocols described by different authors of the area.
These sessions will be conducted inside of the children's normal physical education lessons. A Physical Education Professor will make the interventions. Thus, the study will be divided into four moments: T1 (recruitment and screening), T2 assessment before the intervention, and T3 and T4 for assessment after intervention and assessment follow up.
Sample size The sample is calculated a with variance analysis (ANOVA one way) (one independent variable) with an anticipated statistical power of 0.95, an error probability of 0.05, and effect size of 0.5, predicted that the appropriate sample size for the present study is 54 participants (G-power program 3.1.3, Germany).
The subject sample is comprised of 54 elementary school students aged 9-12 years. Participants and their parents had to sign a written consent containing all the information of the study prior to the commencing day.
Statistical analysis The normality distribution of the data will be checked with the Kolmogorov-Smirnov test. All data will be expressed as averages and standard deviations (DS).
ANOVA will be used to ensure that all 2 groups are homogeneous according to cardiorespiratory fitness and body composition before training.
The effects of training will be statistically analysed using post-hoc Tukey test in order to compare the variables present among the mean value groups between pre and post test (time effect). For each variable, there is an effect that could be attributed to the intervention or the gender. Therefore, in both groups, data for boys and girls will be collected and analysed by a 2-way ANOVA. The threshold for statistical significance is set at p ≤ 0.05. All analyses will be performed using Statistical Package for the Social Sciences (IBM SPSS) version 22.0.
The study contributes to scientific knowledge since it studies the effects of a new method of physical exercise which still lacks full clarity regarding its implementation and effect in variables like cardiorespiratory fitness and body composition in children.
The study is guided by practice-based scientific evidence for the use of HIIT in children. Upon completion of data collection, it is expected that the HIIG volunteers will benefit from increased cardiorespiratory fitness through the 20 meters shuttle run test, improved body composition through the decreased body fat mass and increased body muscle mass, reductions in scores on the IMC, and waist circumference. In the MIG, no significant changes in the values of any variable analysed are expected. It is believed that the desired results could be attributed to physiological effects of exercises of high-intensity intermittent exercises associated with the proposed exercise protocol.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Children
Ages of 8 to 12
Tanner 1-2
Are not part of any regular exercise training program
Agree to the commitment
Exclusion Criteria:
Chronic paediatric disease (except for obesity)
Cardiovascular or metabolic disease
Orthopaedic limitation
High-intensity intermittent games (HIIG): complete a supervised 12-weeks. Twice per week child-specific games program, intensity HRmax 75% ≤ - RPE 6-8.
Behavioral: High-intensity intermittent games
Moderate intensity games (MIG): complete a supervised 12-weeks. Twice per week child-specific games program, intensity HRmax 60-74% ≤ - RPE 4-5.
Behavioral: Moderate intensity games
The intervention will last for 12-weeks, each group included participation in twice-week 40 minutes exercise sessions. In HIIG children took part in 5 games per session; 2 velocity games and 3 small-sided games (such 3 vs 3 and 4 vs 4). This session included 4 minutes games and 2 minutes recovery. In MIG children took part in 5 games per session. This session included 4 minutes games and 3 minutes recovery.
The intervention will last for 12-weeks, each group included participation in twice-week 40 minutes exercise sessions. In MIG children took part in 5 games per session. This session included 4 minutes games and 3 minutes recovery.
Change in cardiorespiratory fitness; 20 meters shuttle run test
Maximum oxygen uptake (VO2max) metric: ml·kg-1·min-1
Time frame: Pre - post intervention and follow up. Time which each participant is assessed; 40 minutes
Plan to share: No — 2 congresses 2 publications
Started Aug 2017 (actual). Primary completion is estimated for Mar 2018, 7 months after the start.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 7 months is below that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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