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NCT Number: NCT01411605

Influence of Cardio-ventilatory Factors on Exercise Intolerance in Obese Adolescents: Effects of Exercise Training

Worldwide, childhood and adolescent obesity has reached epidemic proportions despite major efforts to promote weight reduction. Pediatric obesity commonly presages adult obesity and is associated with the development of weight-related comorbid conditions and increased morbidity.

Regular physical activity is an important modality of obesity management. Despite controversies, poor exercise tolerance has frequently been reported in youth obesity and the cause of this limited exercise tolerance remains unknown. Several factors accompanying obesity may interfere with exercise tolerance in obese populations. Respiratory factors, such as decreased thoracic compliance, increased airway resistance and breathing at low pulmonary volumes are associated with obesity and may impact exercise intolerance in this population. Moreover, even in people with otherwise normal lungs, the normal ventilatory responses to exercise can become constrained in obesity. A thorough understanding of the mechanisms underlying this exercise intolerance remains fundamental in order to favour long term adherence to exercise training. This is especially true in youth populations, in which the management of overweight and obesity must be undertaken as soon as possible, due to the early onset of cardiovascular risk factors.

The main purpose of this study is to determine early-onset cardio-respiratory mortality factors in obese adolescents as well as their relation with exercise intolerance (i.e. dyspnea) when compared with age and gender-paired normal-weight volunteers.

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Key information

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Grenoble

Grenoble, 38000, France

About this study

Physiopathological trial. Expected total enrollment : 20 obese adolescents + 20 control subjects Tested treatment: Exercise training (4 hours per week). Treatment duration: 12 weeks

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female obese adolescents (BMI > IOTF 30, 12-16 years old)

Exclusion criteria

  • Cardiovascular pathology
  • Pathology interfering with physical activity (neurological pathology, severe respiratory illness i.e. asthma, renal failure)
  • Diabetes (known or treated)
  • Participation in another study
  • Asthma (known and treated)

Treatment and study plan

Exercise Training

Behavioral

12-week supervised exercise-training (ET) program consisting of two 60-min and one 120-min exercise sessions per week which focus mainly on aerobic exercises (cycling, treadmill, rower).

Initial aerobic exercise intensity is set at 60 % of HR peak and will reach 80 % at the end of the ET protocol.

Primary outcomes

  1. Exercise tolerance (Expiratory flow limitation and Operational Lung Volumes at rest and exercise, cardiorespiratory and subjective responses to incremental exercise)

    Time frame: Participants will be followed for the duration of exercise training, an expected average of 12 weeks

Secondary outcomes

  1. Polysomnography

    Time frame: Participants will be followed for the duration of exercise training, an expected average of 12 weeks

    Explore the potential existence of obstructive sleep apnea and its effects on cardiovascular adaptations during exercise.

  2. Cardiorespiratory fitness (VO2max)

    Time frame: Participants will be followed for the duration of exercise training, an expected average of 12 weeks

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: VENTILOBE

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Aug 8, 2011
Registry last updated
Jun 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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