AzTrials
AzTrials

Children, Physical ActivityHIIGNCT03308500

Effect of High-intensity Intermittent Games on Cardiorespiratory Fitness and Body Composition in Children

A study testing High-intensity intermittent games and Moderate intensity games in people with Children, Physical Activity, run by Grupo Lusófona at 1 site in Chile.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 8 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Children, Physical Activity
What is being tested?
High-intensity intermittent games and Moderate intensity games
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteChile
Study dates
15 Aug 2017to 30 Dec 2018
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 8 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Children
  • Ages of 8 to 12
  • Tanner 1-2
  • Are not part of any regular exercise training program
  • Agree to the commitment

Who cannot join

  • Chronic paediatric disease (except for obesity)
  • Cardiovascular or metabolic disease
  • Orthopaedic limitation

Trial locations and contacts

1 site in 1 country.

Chile1 site
  • University Playa Ancha

    Valparaíso, 2340000

Other trials in Chile

About this study

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.

Read the 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.

Being tested
High-intensity intermittent games, Moderate intensity games
Keywords
HIIT, Children, Cardiorespiratory fitness, Body composition
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-intensity intermittent gamesBehavioural

    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.

  • Moderate intensity gamesBehavioural

    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.

Study groups in NCT03308500
Study groupRoleWhat they receive
High-intensity intermittent games HIIGExperimentalHigh-intensity intermittent games (HIIG): complete a supervised 12-weeks. Twice per week child-specific games program, intensity HRmax 75% ≤ - RPE 6-8.
Receives: Behavioral: High-intensity intermittent games
Moderate-intensity games (MIG)Active comparatorModerate intensity games (MIG): complete a supervised 12-weeks. Twice per week child-specific games program, intensity HRmax 60-74% ≤ - RPE 4-5.
Receives: Behavioral: Moderate intensity games

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in cardiorespiratory fitness; 20 meters shuttle run test

    Maximum oxygen uptake (VO2max) metric: ml·kg-1·min-1

    Measured: Pre - post intervention and follow up. Time which each participant is assessed; 40 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2017
  2. Study start15 Aug 2017
  3. Primary completion30 Mar 2018 (estimated)
  4. Study completion30 Dec 2018 (estimated)

Resources

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
Model description
Experimental design is applied where HIIG is compared with MIG. The participants of the study will be divided into two groups; HIIG and MIG. Both of them will have two sessions per week during 12 weeks of intervention. Follow up: children are contacted 3 months after finishing the intervention.
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03308500
Sponsor's protocol ID
LUSUP21231016
Acronym
HIIG
Status last verified
Oct 2017
First submitted
9 Oct 2017
Last updated
19 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 2 congresses 2 publications

Publications

  • 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.

    PubMed 26009003
  • 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.

    PubMed 20421958
  • 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.

    PubMed 24662421
  • 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.

    PubMed 20708746
  • 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.

    PubMed 26739675
  • 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.

    PubMed 24533471
  • 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.

    PubMed 20459784
  • 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.

    PubMed 26352388
  • 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.

    PubMed 23044984

Questions about this trial

What is this clinical trial studying?

A study testing High-intensity intermittent games and Moderate intensity games in people with Children, Physical Activity, run by Grupo Lusófona at 1 site in Chile.

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 5 inclusion and 3 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 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

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 cardiorespiratory fitness; 20 meters shuttle run test (time frame: Pre - post intervention and follow up. Time which each participant is assessed; 40 minutes). 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 NCT03308500, which also lists 9 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 19 Oct 2017.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in