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Effects of Exercise Intensity in Obese Children and Adolescents

19 februari 2018 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

7 år till 16 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: High intensity interval training
Twelve weeks of 2-3 supervised training sessions each week.
Andra namn:
  • HIIT
Kosttillskott: Nutritional advice
healthy food choices, portion sizes and regular mealtimes
Experimentell: Moderate intensity continuous training
walking, running or cycling continuously at 60-70% HRmax for 44 minutes.
Kosttillskott: Nutritional advice
healthy food choices, portion sizes and regular mealtimes
Beteende: Moderate intensity continuous training
Twelve weeks of 2-3 supervised training sessions each week.
Andra namn:
  • 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.
Kosttillskott: Nutritional advice
healthy food choices, portion sizes and regular mealtimes
Inget ingripande: non-obese children
100 healthy non-obese children aged 7-16 (controls)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Peak systolic tissue velocity
Tidsram: 12 weeks
systolic tissue Doppler velocity assessed during resting and stress echocardiography
12 weeks

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Norwegian University of Science and Technology

Samarbetspartners

The University of Queensland

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 november 2013

Primärt slutförande (Faktisk)

31 mars 2017

Avslutad studie (Faktisk)

31 mars 2017

Studieregistreringsdatum

Först inskickad

18 november 2013

Först inskickad som uppfyllde QC-kriterierna

18 november 2013

Första postat (Uppskatta)

25 november 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 februari 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 februari 2018

Senast verifierad

1 februari 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2009/1313

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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