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Effects of Exercise Intensity in Obese Children and Adolescents

19. februar 2018 opdateret af: Norwegian University of Science and Technology

A Multi-centre Randomized Controlled Trial Examining the Effects of High Intensity Interval Training on Cardio-metabolic Outcomes in Obese Children and Adolescents

The prevalence of paediatric obesity has increased over the last two decades and with it, an increased diagnosis of lifestyle-related diseases in children and adolescents. High intensity interval training has recently been explored as an alternate to traditional aerobic exercise in adults with chronic disease and has potential to induce rapid reversal of subclinical disease markers in obese children and adolescents.

High intensity interval training has recently been explored as an alternate to traditional aerobic exercise in adults with chronic disease and has potential to induce rapid reversal of subclinical disease markers in obese children and adolescents.

Goal: The primary aim of this randomised controlled trial is to evaluate the effectiveness of a high intensity interval training intervention on myocardial function, vascular function and visceral adipose tissue in obese children and adolescents at baseline, three and twelve months.

Method: Multi-centre randomised controlled trial of 100 obese children and adolescents in the cities of Trondheim (Norway) and Brisbane (Australia). Participants will be randomised to (1) high intensity interval training, (2) moderate intensity continuous training or (3) nutrition advise. Participants will partake in supervised exercise training and/or nutrition consultations for 3 months. Measurements for all study endpoints will occur at baseline, 3 months (post intervention) and 12 months (follow up).

Scientific Significance : This randomised controlled trial will general substantial information regarding the effects of exercise intensity on paediatric obesity, specifically the cardio-metabolic health of this at-risk population. It is expected that communication of results will allow for more robust and realistic guidelines regarding exercise prescription in this population to be formed while outlining the benefits of high intensity interval training on subclinical markers of disease.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Worldwide, childhood overweight and obesity rates are approximately 10%, this high incidence attributed to a physically inactive lifestyle and inappropriate nutrition. Early cohort studies illustrated that fifty per cent of obese children became obese adults and consequently had an higher risk for metabolic syndrome than obese adults who were not obese as children. Both female and male overweight children and adolescents had a 30% increase in all cause mortality. The increases in risk of death were independent of adult body mass index.

Systematic reviews suggest that lifestyle and exercise interventions in obese children and adolescents can lead to improvements in anthropometric and cardio-metabolic outcomes, but these are not inclusive of several important outcomes such as myocardial and vascular function or visceral adipose tissue.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
      • Brisbane, Australien
        • University of Queensland
  • Norge
      • Trondheim, Norge
        • St Olavs hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

7 år til 16 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

- Obese (BMI ≥ 95th percentile - age and sex specific criteria)

Exclusion Criteria:

  • Elevated blood pressure (≥ 95th percentile for systolic or diastolic values)
  • Congenital heart disease
  • Coronary artery disease
  • Family history of hypertropic obstructive cardiomyopathy
  • Any abnormality during rest or stress echocardiography which indicates it would be unsafe to participate
  • Self reported kidney failure
  • Any major organ transplant
  • Considerable pulmonary disease including severe or poorly controlled asthma
  • Smoking
  • Diabetes
  • Epilepsy or a history of seizures
  • Orthopaedic or neurological limitations to exercise
  • Diagnosed attention deficit hypersensitivity disorder
  • Steroid medications
  • Participation in another research study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: High intensity interval training
10-minute warm up at 60-70% of maximal heart rate (HRmax). Then walking, running or cycling at 85-95% of maximal heart rate at intervals of 4 x 4 minutes, with 3 minute active breaks (50-70% of HRmax) between intervals. A 5-minute cool down period.
Adfærdsmæssigt: High intensity interval training
Twelve weeks of 2-3 supervised training sessions each week.
Andre navne:
  • HIIT
Kosttilskud: Nutritional advice
healthy food choices, portion sizes and regular mealtimes
Eksperimentel: Moderate intensity continuous training
walking, running or cycling continuously at 60-70% HRmax for 44 minutes.
Kosttilskud: Nutritional advice
healthy food choices, portion sizes and regular mealtimes
Adfærdsmæssigt: Moderate intensity continuous training
Twelve weeks of 2-3 supervised training sessions each week.
Andre navne:
  • MICT
Aktiv komparator: nutritional advice
10 individual nutrition consultations with an accredited dietitian over the 12 month period. Content of consultations will include healthy food choices, portion sizes and regular mealtimes.
Kosttilskud: Nutritional advice
healthy food choices, portion sizes and regular mealtimes
Ingen indgriben: non-obese children
100 healthy non-obese children aged 7-16 (controls)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Peak systolic tissue velocity
Tidsramme: 12 weeks
systolic tissue Doppler velocity assessed during resting and stress echocardiography
12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Subcutaneous and total abdominal adipose tissue
Tidsramme: 12 weeks, 12 months
Assessed using MRI
12 weeks, 12 months
Cardiorespiratory fitness (VO2peak)
Tidsramme: 12 weeks, 12 months
Assessed using a maximal treadmill test
12 weeks, 12 months
Body composition
Tidsramme: 12 weeks, 12 months
Assessed using DXA (UQ), BodPod (NTNU)
12 weeks, 12 months
Blood biochemistry
Tidsramme: 12 weeks, 12 months
Analysed for lipids, glucose, insulin, inflammatory makers, satiety hormones, oxidative stress
12 weeks, 12 months
Physical activity
Tidsramme: 12 weeks, 12 months
Assessed through 7 day accelerometry
12 weeks, 12 months
Dietary analysis
Tidsramme: 12 weeks, 12 months
Assessed through a three-day food record
12 weeks, 12 months
Myocardial structure and cardiac adipose tissue (UQ)
Tidsramme: 12 weeks
Assessed through cardiac MRI; participants > 12 years only
12 weeks
Arterial stiffness
Tidsramme: 12 weeks, 12 months
Assessed through pulse wave velocity and pulse wave analysis
12 weeks, 12 months
Autonomic function
Tidsramme: 12 weeks, 12 months
Assessed through heart rate variability and heart rate recovery
12 weeks, 12 months
Quality of life
Tidsramme: 12 weeks, 12 months
Assessed through the Paediatric Quality of Life Inventory
12 weeks, 12 months
Visceral adipose tissue
Tidsramme: 12 weeks, 12 months
assessed by magnetic resonance imaging (MRI)
12 weeks, 12 months
Vascular function
Tidsramme: 12 weeks, 12 months
Assessed through flow mediated dilation procedure
12 weeks, 12 months
Peak systolic tissue velocity
Tidsramme: 12 months
systolic tissue Doppler velocity assessed during resting and stress echocardiography
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Norwegian University of Science and Technology

Samarbejdspartnere

The University of Queensland

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2013

Primær færdiggørelse (Faktiske)

31. marts 2017

Studieafslutning (Faktiske)

31. marts 2017

Datoer for studieregistrering

Først indsendt

18. november 2013

Først indsendt, der opfyldte QC-kriterier

18. november 2013

Først opslået (Skøn)

25. november 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. februar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. februar 2018

Sidst verificeret

1. februar 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2009/1313

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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