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Clinical Trials/ACTRN12613001037796
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.

Registry
who.int
Start Date
September 18, 2013
End Date
October 1, 2016
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Professor Jeff Coombes

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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