Effects of Exercise on Arterial Function and Insulin Resistance Syndrome in Pre-pubertal Obese Children

NCT ID: NCT00801645

Last Updated: 2012-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2010-06-30

Brief Summary

The main purpose of this project is to investigate the effects of an exercise program on arterial function and cardiovascular diseases risk factors in obese and lean pre-pubertal children. This information will be used to underpin prevention strategies to reduce cardiovascular diseases in overweight youth.

Detailed Description

Introduction: cardiovascular diseases (CVD) are the major contributor to the global burden of non-communicable diseases, one third of all global death being attributed to CVD. Childhood obesity poses a major public health problem and there is increasing evidence that foundation of cardiovascular diseases lays early in life in obese children. There is therefore an urgent need to identify effective prevention strategies. Physical activity is recognized as major determinants of cardiovascular health in adults and adolescents however, little is known in young children. The main purpose of this project is to investigate the effects of a 3-month exercise training program on arterial function and cardiovascular diseases risk factors in obese and lean children.

Methods: This is a randomized controlled trial including 4 groups of pre-pubertal children aged 6 to 11 years old: 1) obese exercise, 2) obese control, 3) lean exercise, and 4) lean control. The exercise groups engage in aerobic exercise training three 60-minute sessions per week for 12 weeks, in addition of school physical education. Training sessions consist of 30 minutes of aerobic exercise (walking, running, games, swimming), followed by strength training and stretching. Controls are relatively inactive. After the 3-month intervention, the obese control group engages in an identical 12-week exercise program and the obese exercise group is encouraged to continue for a total of 6 months. Primary measures include: 24-hour ambulatory systolic and diastolic blood pressure; endothelial function and mechanical indices of the brachial and carotid arteries using a B-mode ultrasound imager; central blood pressure and pulse wave velocity by tonometry of aplanation. Other measures include: body composition, physical activity, cardio-respiratory fitness, nutrition, quality of life, and fasting blood lipids, insulin, glucose, markers of vascular function and inflammation. Testing is performed at baseline, 3, 6 and 24 months in obese children and at baseline and 3 months in lean children.

We hypothesize that exercise training will result in improved arterial function, body composition and markers of the metabolic syndrome in obese children. This information will be used to underpin prevention strategies to reduce CVD risk factors in this high-risk population.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Obese exercise

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

The exercise groups engage in aerobic exercise training three 60-minute sessions per week for 12 weeks, in addition of school physical education. Training sessions consist of 30 minutes of aerobic exercise (walking, running, games, swimming), followed by strength training and stretching.

Obese Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Lean Exercise

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

The exercise groups engage in aerobic exercise training three 60-minute sessions per week for 12 weeks, in addition of school physical education. Training sessions consist of 30 minutes of aerobic exercise (walking, running, games, swimming), followed by strength training and stretching.

Lean Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

The exercise groups engage in aerobic exercise training three 60-minute sessions per week for 12 weeks, in addition of school physical education. Training sessions consist of 30 minutes of aerobic exercise (walking, running, games, swimming), followed by strength training and stretching.

Intervention Type: BEHAVIORAL

Other Intervention Names

Physical activity

Eligibility Criteria

Inclusion Criteria

• obese children: Pre-pubertal (Tanner stage 1), BMI > 97th age- and gender-specific percentile (Kromeyer-Hauschild et al. 2001).
• lean subjects: Pre-pubertal (Tanner stage 1), BMI > 10th and < 90th age- and gender-specific percentile.

Exclusion Criteria

• being involved in any weight control, physical activity, or behavioral therapy
• familial history of dyslipidemia or essential hypertension
• medications or hormones, which may influence cardiovascular function, body composition, lipid or glucose metabolism
• orthopedic affection limiting physical activity
• genetic disorder or a chronic disease
• following a therapy for psychiatric problems

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Swiss National Science Foundation

OTHER

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Nathalie Farpour-Lambert

Head of the Obesity Care Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maurice Beghetti, PD

Role: STUDY_DIRECTOR

Pediatric Cardiology Unit, Departement of Child and Adolescent, University Hospital, Geneva

Nathalie J Farpour-Lambert, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatric Cardiology Unit, Department of Child and Adolescent, University Hospital, Geneva

Locations

Department of Child and Adolescent, University Hospital of Geneva

Geneva, Canton of Geneva, Switzerland

Countries

Switzerland

References

Maggio AB, Aggoun Y, Martin XE, Marchand LM, Beghetti M, Farpour-Lambert NJ. Long-term follow-up of cardiovascular risk factors after exercise training in obese children. Int J Pediatr Obes. 2011 Jun;6(2-2):e603-10. doi: 10.3109/17477166.2010.530665. Epub 2010 Dec 10.

Reference Type: DERIVED

PMID: 21142752 (View on PubMed)

Farpour-Lambert NJ, Aggoun Y, Marchand LM, Martin XE, Herrmann FR, Beghetti M. Physical activity reduces systemic blood pressure and improves early markers of atherosclerosis in pre-pubertal obese children. J Am Coll Cardiol. 2009 Dec 15;54(25):2396-406. doi: 10.1016/j.jacc.2009.08.030.

Reference Type: DERIVED

PMID: 20082930 (View on PubMed)

Other Identifiers

SNF 3200B0-103853

Identifier Type: -

Identifier Source: org_study_id