Clinical trial NCT01991106: Effects of Exercise Intensity in Obese Children and Adolescents
Official title: A Multi-centre Randomized Controlled Trial Examining the Effects of High Intensity Interval Training on Cardio-metabolic Outcomes in Obese Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Exercise
Myocardial function
Vascular function
Cardiovascular disease/prevention & control
Paediatric obesity
Visceral adipose tissue
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: The University of Queensland
First posted: 2013-11-25
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak systolic tissue velocity
timeFrame: 12 weeks
Secondary outcomes:
measure: Subcutaneous and total abdominal adipose tissue
timeFrame: 12 weeks, 12 months
measure: Cardiorespiratory fitness (VO2peak)
timeFrame: 12 weeks, 12 months
measure: Body composition
timeFrame: 12 weeks, 12 months
measure: Blood biochemistry
timeFrame: 12 weeks, 12 months
measure: Physical activity
timeFrame: 12 weeks, 12 months
measure: Dietary analysis
timeFrame: 12 weeks, 12 months
measure: Myocardial structure and cardiac adipose tissue (UQ)
timeFrame: 12 weeks
measure: Arterial stiffness
timeFrame: 12 weeks, 12 months
measure: Autonomic function
timeFrame: 12 weeks, 12 months
measure: Quality of life
timeFrame: 12 weeks, 12 months
measure: Visceral adipose tissue
timeFrame: 12 weeks, 12 months
measure: Vascular function
timeFrame: 12 weeks, 12 months
measure: Peak systolic tissue velocity
timeFrame: 12 months
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: University of Queensland
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Ulrik Wisløff, prof
role: STUDY_DIRECTOR
References:
citation: Dias KA, Coombes JS, Green DJ, Gomersall SR, Keating SE, Tjonna AE, Hollekim-Strand SM, Hosseini MS, Ro TB, Haram M, Huuse EM, Davies PS, Cain PA, Leong GM, Ingul CB. Effects of exercise intensity and nutrition advice on myocardial function in obese children and adolescents: a multicentre randomised controlled trial study protocol. BMJ Open. 2016 Apr 4;6(4):e010929. doi: 10.1136/bmjopen-2015-010929.
citation: Dias KA, Ingul CB, Tjonna AE, Keating SE, Gomersall SR, Follestad T, Hosseini MS, Hollekim-Strand SM, Ro TB, Haram M, Huuse EM, Davies PSW, Cain PA, Leong GM, Coombes JS. Effect of High-Intensity Interval Training on Fitness, Fat Mass and Cardiometabolic Biomarkers in Children with Obesity: A Randomised Controlled Trial. Sports Med. 2018 Mar;48(3):733-746. doi: 10.1007/s40279-017-0777-0.
citation: Ingul CB, Dias KA, Tjonna AE, Follestad T, Hosseini MS, Timilsina AS, Hollekim-Strand SM, Ro TB, Davies PSW, Cain PA, Leong GM, Coombes JS. Effect of High Intensity Interval Training on Cardiac Function in Children with Obesity: A Randomised Controlled Trial. Prog Cardiovasc Dis. 2018 Jul-Aug;61(2):214-221. doi: 10.1016/j.pcad.2018.01.012. Epub 2018 Feb 13.
citation: Dias KA, Ramos JS, Wallen MP, Davies PSW, Cain PA, Leong GM, Ingul CB, Coombes JS, Keating SE. Accuracy of Longitudinal Assessment of Visceral Adipose Tissue by Dual-Energy X-Ray Absorptiometry in Children with Obesity. J Obes. 2019 Nov 3;2019:2193723. doi: 10.1155/2019/2193723. eCollection 2019.
citation: Dias KA, Spence AL, Sarma S, Oxborough D, Timilsina AS, Davies PSW, Cain PA, Leong GM, Ingul CB, Coombes JS. Left ventricular morphology and function in adolescents: Relations to fitness and fatness. Int J Cardiol. 2017 Aug 1;240:313-319. doi: 10.1016/j.ijcard.2017.03.047. Epub 2017 Mar 11.