Effects of Exercise Intensity in Obese Children and Adolescents
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.
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
Twelve weeks of 2-3 supervised training sessions each week.
其他名称：
healthy food choices, portion sizes and regular mealtimes
|
|
实验性的：Moderate intensity continuous training
walking, running or cycling continuously at 60-70% HRmax for 44 minutes.
|
healthy food choices, portion sizes and regular mealtimes
Twelve weeks of 2-3 supervised training sessions each week.
其他名称：
|
|
有源比较器：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.
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healthy food choices, portion sizes and regular mealtimes
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|
无干预：non-obese children
100 healthy non-obese children aged 7-16 (controls)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Peak systolic tissue velocity
大体时间：12 weeks
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systolic tissue Doppler velocity assessed during resting and stress echocardiography
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12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Subcutaneous and total abdominal adipose tissue
大体时间：12 weeks, 12 months
|
Assessed using MRI
|
12 weeks, 12 months
|
|
Cardiorespiratory fitness (VO2peak)
大体时间：12 weeks, 12 months
|
Assessed using a maximal treadmill test
|
12 weeks, 12 months
|
|
Body composition
大体时间：12 weeks, 12 months
|
Assessed using DXA (UQ), BodPod (NTNU)
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12 weeks, 12 months
|
|
Blood biochemistry
大体时间：12 weeks, 12 months
|
Analysed for lipids, glucose, insulin, inflammatory makers, satiety hormones, oxidative stress
|
12 weeks, 12 months
|
|
Physical activity
大体时间：12 weeks, 12 months
|
Assessed through 7 day accelerometry
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12 weeks, 12 months
|
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Dietary analysis
大体时间：12 weeks, 12 months
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Assessed through a three-day food record
|
12 weeks, 12 months
|
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Myocardial structure and cardiac adipose tissue (UQ)
大体时间：12 weeks
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Assessed through cardiac MRI; participants > 12 years only
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12 weeks
|
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Arterial stiffness
大体时间：12 weeks, 12 months
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Assessed through pulse wave velocity and pulse wave analysis
|
12 weeks, 12 months
|
|
Autonomic function
大体时间：12 weeks, 12 months
|
Assessed through heart rate variability and heart rate recovery
|
12 weeks, 12 months
|
|
Quality of life
大体时间：12 weeks, 12 months
|
Assessed through the Paediatric Quality of Life Inventory
|
12 weeks, 12 months
|
|
Visceral adipose tissue
大体时间：12 weeks, 12 months
|
assessed by magnetic resonance imaging (MRI)
|
12 weeks, 12 months
|
|
Vascular function
大体时间：12 weeks, 12 months
|
Assessed through flow mediated dilation procedure
|
12 weeks, 12 months
|
|
Peak systolic tissue velocity
大体时间：12 months
|
systolic tissue Doppler velocity assessed during resting and stress echocardiography
|
12 months
|
合作者和调查者
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
- 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.
- 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.
研究记录日期
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学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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