Effects of Exercise on Arterial Function and Insulin Resistance Syndrome in Pre-pubertal Obese Children
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity |
Behavioral: Exercise |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effects of Aerobic Exercise Training on Arterial Function and Insulin Resistance Syndrome in Obese Children: A Randomized Controlled Trial |
- Arterial function [ Time Frame: 0-3-6-24 months ] [ Designated as safety issue: No ]
- Body composition [ Time Frame: 0-3-6-24 months ] [ Designated as safety issue: No ]
- Body mass index [ Time Frame: 0-3-6-24 months ] [ Designated as safety issue: No ]
- Cardiorespiratory fitness [ Time Frame: 0-3-6-24 months ] [ Designated as safety issue: No ]
- Physical activity [ Time Frame: 0-3-6-24 months ] [ Designated as safety issue: No ]
- Insulin resistance [ Time Frame: 0-3-6-24 months ] [ Designated as safety issue: No ]
- Blood lipids [ Time Frame: 0-3-6-24 months ] [ Designated as safety issue: No ]
- Biological markers of endothelial function [ Time Frame: 0-3-6-24 months ] [ Designated as safety issue: No ]
- High sensitive C-reactive protein [ Time Frame: 0-3-6-24 months ] [ Designated as safety issue: No ]
- Resting and ambulatory blood pressure [ Time Frame: 0-3-6-24 months ] [ Designated as safety issue: No ]
| Enrollment: | 67 |
| Study Start Date: | August 2004 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Obese exercise |
Behavioral: 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.
Other Name: Physical activity
|
| No Intervention: Obese Control | |
| Experimental: Lean Exercise |
Behavioral: 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.
Other Name: Physical activity
|
| No Intervention: Lean Control |
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.
Eligibility| Ages Eligible for Study: | 6 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Switzerland | |
| Department of Child and Adolescent, University Hospital of Geneva | |
| Geneva, Switzerland, 1205 | |
| Study Director: | Maurice Beghetti, PD | Pediatric Cardiology Unit, Departement of Child and Adolescent, University Hospital, Geneva |
| Principal Investigator: | Nathalie J Farpour-Lambert, MD | Pediatric Cardiology Unit, Department of Child and Adolescent, University Hospital, Geneva |
More Information
No publications provided by University Hospital, Geneva
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Nathalie Farpour-Lambert, Head of the Obesity Care Program, University Hospital, Geneva |
| ClinicalTrials.gov Identifier: | NCT00801645 History of Changes |
| Other Study ID Numbers: | SNF 3200B0-103853 |
| Study First Received: | December 2, 2008 |
| Last Updated: | January 4, 2012 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by University Hospital, Geneva:
|
Obesity Cardiovascular disease Endothelial function Blood pressure Exercise |
Physical activity Metabolic syndrome Children Pediatric |
Additional relevant MeSH terms:
|
Insulin Resistance Metabolic Syndrome X Obesity Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013