- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03308500
Effect of High-intensity Intermittent Games on Cardiorespiratory Fitness and Body Composition in Children (HIIG)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Valparaíso, Chile, 2340000
- University Playa Ancha
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High-intensity intermittent games HIIG
High-intensity intermittent games (HIIG): complete a supervised 12-weeks.
Twice per week child-specific games program, intensity HRmax 75% ≤ - RPE 6-8.
|
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.
|
Active Comparator: Moderate-intensity games (MIG)
Moderate intensity games (MIG): complete a supervised 12-weeks.
Twice per week child-specific games program, intensity HRmax 60-74% ≤ - RPE 4-5.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cardiorespiratory fitness; 20 meters shuttle run test
Time Frame: Pre - post intervention and follow up. Time which each participant is assessed; 40 minutes
|
Maximum oxygen uptake (VO2max) metric: ml·kg-1·min-1
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Pre - post intervention and follow up. Time which each participant is assessed; 40 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tomás R Reyes, MSc, Faculty of Physical Education and Sport, University Lusofona/Faculty of Sciences Physical Activity and Sports, University Playa Ancha
- Study Director: Antonio L Palmeira, PhD, Faculty of Physical Education and Sport, University Lusofona
Publications and helpful links
General Publications
- Janssen I, Leblanc AG. Systematic review of the health benefits of physical activity and fitness in school-aged children and youth. Int J Behav Nutr Phys Act. 2010 May 11;7:40. doi: 10.1186/1479-5868-7-40.
- Lambrick D, Westrupp N, Kaufmann S, Stoner L, Faulkner J. The effectiveness of a high-intensity games intervention on improving indices of health in young children. J Sports Sci. 2016;34(3):190-8. doi: 10.1080/02640414.2015.1048521. Epub 2015 May 26.
- Lee YH, Song YW, Kim HS, Lee SY, Jeong HS, Suh SH, Park JK, Jung JW, Kim NS, Noh CI, Hong YM. The effects of an exercise program on anthropometric, metabolic, and cardiovascular parameters in obese children. Korean Circ J. 2010 Apr;40(4):179-84. doi: 10.4070/kcj.2010.40.4.179. Epub 2010 Apr 23.
- Murphy A, Kist C, Gier AJ, Edwards NM, Gao Z, Siegel RM. The feasibility of high-intensity interval exercise in obese adolescents. Clin Pediatr (Phila). 2015 Jan;54(1):87-90. doi: 10.1177/0009922814528038. Epub 2014 Mar 24. No abstract available.
- Howe CA, Freedson PS, Feldman HA, Osganian SK. Energy expenditure and enjoyment of common children's games in a simulated free-play environment. J Pediatr. 2010 Dec;157(6):936-942.e1-2. doi: 10.1016/j.jpeds.2010.06.041. Epub 2010 Aug 13.
- Fernandes RA, Zanesco A. Early sport practice is related to lower prevalence of cardiovascular and metabolic outcomes in adults independently of overweight and current physical activity. Medicina (Kaunas). 2015;51(6):336-42. doi: 10.1016/j.medici.2015.10.003. Epub 2015 Nov 17.
- Bendiksen M, Williams CA, Hornstrup T, Clausen H, Kloppenborg J, Shumikhin D, Brito J, Horton J, Barene S, Jackman SR, Krustrup P. Heart rate response and fitness effects of various types of physical education for 8- to 9-year-old schoolchildren. Eur J Sport Sci. 2014;14(8):861-9. doi: 10.1080/17461391.2014.884168. Epub 2014 Feb 18.
- McNarry MA, Lambrick D, Westrupp N, Faulkner J. The influence of a six-week, high-intensity games intervention on the pulmonary oxygen uptake kinetics in prepubertal obese and normal-weight children. Appl Physiol Nutr Metab. 2015 Oct;40(10):1012-8. doi: 10.1139/apnm-2015-0051. Epub 2015 Jun 12.
- Metcalf B, Henley W, Wilkin T. Effectiveness of intervention on physical activity of children: systematic review and meta-analysis of controlled trials with objectively measured outcomes (EarlyBird 54). BMJ. 2012 Sep 27;345:e5888. doi: 10.1136/bmj.e5888.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LUSUP21231016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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