An observational study in Obesity, Childhood, Cardiac Disease and Cardiovascular Risk Factor, sponsored by Hasselt University. Status unknown at 1 site in Belgium. Open to participants aged 11 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-12-04.
Sponsored by Hasselt University · Observational
In adolescents with obesity cardiopulmonary exercise testing (CPET) has become an important clinical examination providing valuable information with regard to the integrative exercise responses, including the pulmonary, cardiovascular and muscular systems.
During CPET, mechanical constraints in ventilation, an elevated risk for hypoxia and chronotropic incompetence (CI) (defined as the inability of the heart to increase its rate with increased activity), or compromised cardiac function (e.g. lowered heart rate (HR) recovery, chronotropic index and stroke volume) are often observed in obese adults. Moreover, several studies regarding exercise capacity and cardiopulmonary responses to maximal endurance exercise testing have been performed in obese adolescents. Despite these previous investigations in obese adolescents it remains controversial whether cardiopulmonary disturbances can be observed consistently during CPET. However, a number of studies have reported a suboptimal response to exercise, in particular a reduced peak heart rate (HRpeak) and peak cycling power output (Wpeak). Adult obesity modifies cardiac behavior, including resting HR and CI, which has a marked effect on exercise capacity. Therefore, chronotropic variables are the most important factors that affect exercise performance. It has been shown that both peak and resting HR account for over forty percent of variability of exercise capacity. Interestingly, resting HR and HR response to exercise, including a blunted HR increase, low chronotropic index and HR recovery, are important predictors of all-cause mortality and cardiovascular death, at least in adults. These changes in HR during and recovery from CPET are mediated by the balance between sympathetic and vagal activity of the autonomic nervous system. Adverse cardiovascular outcomes associated with the metabolic syndrome may be mediated by autonomic dysfunction, whereby obesity is characterized by sympathetic predominance and a decrease in vagal activity in the basal state, where reduced sympathetic responsiveness has been observed during exercise. Therefore, these multiple exercise risk markers could provide valuable clinical information regarding cardiometabolic health. Nonetheless HR behavior during CPET has not been described in obese adolescents. The goal of this study is to examine the HR behavior of obese adolescents during CPET to clarify whether this population suffer from CI.
1,126 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's planned enrollment of 60 is below the median of 180 across 233 observational studies indexed under Pediatric Obesity.
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Obese adolescents
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Obese adolescents with chronotropic incompetence
Diagnostic Test: The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing
Obese adolescents without chronotropic incompetence
Diagnostic Test: The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing
The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing
Heart rate (HR) during exercise testing
Assessed using a 12-lead ECG device
Time frame: day 1
Peak oxygen uptake (VO2) during exercise testing
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VO2 is collected breath-by-breath and averaged every ten seconds.
Time frame: day 1
Peak workload during exercise testing
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed and the incremental workload is measured
Time frame: day 1
Body height
Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot
Time frame: day 1
Body weight
Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg
Time frame: day 1
Waist circumference
Waist circumference will be measured to the nearest 0.1cm using a flexible metric measuring tape with participants barefoot (in underwear) in standing position. Waist circumference is measured at the midpoint between the lower rib margin and the top of the iliac crest.
Time frame: day 1
Hip circumference
Hip circumference will be measured to the nearest 0.1cm using a flexible metric measuring tape with participants barefoot (in underwear) in standing position. Hip circumference is measured at the widest circumference of the hip at the level of the greater trochanter.
Time frame: day1
Physical activity questionnaire for adolescents (PAQ-A)
physical activity determined using the validated Dutch physical activity questionnaire for adolescents
Time frame: day 1
Tanner stage
Puberty stage (ranging from 1 to 5) will be assessed in all participants by the pediatric endocrinologist using Tanner staging criteria.
Time frame: day 1
Plasma glucose
Blood analyses
Time frame: day 1
Total cholesterol
Blood analyses
Time frame: day 1
High-density lipoprotein cholesterol
Blood analyses
Time frame: day 1
Low-density lipoprotein cholesterol
Blood analyses
Time frame: day 1
Triglyceride concentration
Blood analyses
Time frame: day 1
C-reactive protein
Blood analyses
Time frame: day 1
Serum leptin concentration
Blood analyses
Time frame: day 1
Insulin
Blood analyses
Time frame: day 1
Homeostatic model assessment for insulin resistance (HOMA-IR)
Homeostatic model assessment for insulin resistance calculated from insulin and glucose concentration
Time frame: day 1
Carbon dioxide output (VCO2) during exercise testing
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VCO2 is collected breath-by-breath and averaged every ten seconds.
Time frame: day 1
Minute ventilation(VE) during exercise testing
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VE is collected breath-by-breath and averaged every ten seconds.
Time frame: day 1
Tidal volume (Vt) during exercise testing
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis Vt is collected breath-by-breath and averaged every ten seconds.
Time frame: day 1
Breathing frequency (BF) during exercise testing
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis BF is collected breath-by-breath and averaged every ten seconds.
Time frame: day 1
Plan to share: No
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