A Multi-centre Randomized Controlled Trial Examining the Effects of High Intensity Interval Training on Cardio-metabolic Outcomes in Obese Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Peak systolic tissue velocity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese (BMI ≥ 95th percentile - age and sex specific criteria)
排除标准
- •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
- •Epilepsy or a history of seizures
- •Orthopaedic or neurological limitations to exercise
- •Diagnosed attention deficit hypersensitivity disorder
- •Steroid medications
- •Participation in another research study
研究组 & 干预措施
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.
干预措施: High intensity interval training (Behavioral)
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.
干预措施: Nutritional advice (Dietary Supplement)
Moderate intensity continuous training
walking, running or cycling continuously at 60-70% HRmax for 44 minutes.
干预措施: Moderate intensity continuous training (Behavioral)
Moderate intensity continuous training
walking, running or cycling continuously at 60-70% HRmax for 44 minutes.
干预措施: Nutritional advice (Dietary Supplement)
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.
干预措施: Nutritional advice (Dietary Supplement)
non-obese children
100 healthy non-obese children aged 7-16 (controls)
结局指标
主要结局
Peak systolic tissue velocity
时间窗: 12 weeks
systolic tissue Doppler velocity assessed during resting and stress echocardiography
次要结局
- Physical activity(12 weeks, 12 months)
- Subcutaneous and total abdominal adipose tissue(12 weeks, 12 months)
- Cardiorespiratory fitness (VO2peak)(12 weeks, 12 months)
- Body composition(12 weeks, 12 months)
- Blood biochemistry(12 weeks, 12 months)
- Dietary analysis(12 weeks, 12 months)
- Myocardial structure and cardiac adipose tissue (UQ)(12 weeks)
- Arterial stiffness(12 weeks, 12 months)
- Autonomic function(12 weeks, 12 months)
- Quality of life(12 weeks, 12 months)
- Visceral adipose tissue(12 weeks, 12 months)
- Vascular function(12 weeks, 12 months)
- Peak systolic tissue velocity(12 months)