ACTRN12613001037796
Completed
Phase 3
Effect of exercise intensity on cardiac and vascular function, and intra-abdominal fat in obese children and adolescents.
Professor Jeff Coombes0 sites30 target enrollmentSeptember 18, 2013
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Obesity and overweight in children and adolescents
- Sponsor
- Professor Jeff Coombes
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Gender: Males and females are eligible. The study will endeavour to recruit approximately equal numbers of males and females.
- •Body mass index: Obese individuals, with a body mass index greater than or equal to an equivalent of 30kg/m2 in adults are eligible. Eligibility of obese individuals with a BMI greater than 99th percentile (CDC Growth Charts) will be assessed on an individual basis.
- •Age: Individuals aged 7\-16 years old (inclusive) are eligible.
- •Ethnicity: All ethnic groups are eligible for the study. There is likely to be incidental recruitment of participants of Aboriginal or Torres Strait Islander ethnicity.
- •Blood pressure: Individuals with blood pressure less than the 95th percentile for systolic or diastolic values measured upon three or more occasions will be eligible
- •Lipid control: Individuals with fasting total cholesterol less than 5\.5mmol/L and low\-density lipoprotein cholesterol less than 3\.0mmol/L are eligible.
- •Willingness to participate: Participants must be willing to be randomised to either High Intensity Aerobic Interval Training, Moderate Intensity Exercise or Control groups and to follow the protocol that they have been assigned.
- •Successful completion of self\-monitoring: Successful seven accelerometer compliance and diet diary completion will be an indication of willingness to participate and will be required for eligibility
Exclusion Criteria
- •\- Unwilling to participate or participation in another study
- •\- Coronary heart disease
- •\- Congenital cardiac abnormalities (i.e. anomalous coronary artery origins)
- •\- Family history of hypertrophic obstructive cardiomyopathy
- •\- Any abnormality during the resting or exercise stress echo that indicates it would be unsafe to participate in the intervention
- •\- Self reported kidney failure
- •\- Any major organ transplant
- •\- Considerable pulmonary disease including severe or poorly controlled asthma or exercise induced asthma
- •\- Diabetes
- •\- Epilepsy or history of seizures
Outcomes
Primary Outcomes
Not specified
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