Effect of exercise intensity on cardiac and vascular function, and intra-abdominal fat in obese children and adolescents.

Phase 3

Completed

• Conditions: Obesity and overweight in children and adolescents; Diet and Nutrition - Obesity

• Registration Number: ACTRN12613001037796
• Lead Sponsor: Professor Jeff Coombes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-18
• Study Completion: 2016-10-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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
- Smoking
- Diabetes
- Epilepsy or history of seizures
- Orthopaedic and/or neurological limitations to exercise
- Diagnosed Attention Deficit Hypersensitivity Disorder (ADHD)
- Medications such as steroids
- Conditions not specifically mentioned above may serve as criteria for exclusion at discretion of the clinical site

Study & Design

• Study Type: Interventional
• Study Design: Not specified