Clinical trial NCT04185753: Chronotropic Incompetence During Exercise Testing in Obese Adolescents
Official title: Chronotropic Incompetence During Cardiopulmonary Exercise Testing in Obese Adolescents: Associations With Caridometabolic Health
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity, Childhood
Cardiac Disease
Cardiovascular Risk Factor
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 60
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese adolescents

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* obese or lean (based on extended international (IOTF) body mass index cut-offs for thinness, overweight and obesity)
* Parental permission

Exclusion Criteria:

* Chronic cardiovascular, renal, pulmonary or orthopaedic disease
* Medication use that could possibly influence the heart rate

Primary outcomes:
measure: Heart rate (HR) during exercise testing
timeFrame: day 1
measure: Peak oxygen uptake (VO2) during exercise testing
timeFrame: day 1
measure: Peak workload during exercise testing
timeFrame: day 1
Secondary outcomes:
measure: Body height
timeFrame: day 1
measure: Body weight
timeFrame: day 1
measure: Waist circumference
timeFrame: day 1
measure: Hip circumference
timeFrame: day1
measure: Physical activity questionnaire for adolescents (PAQ-A)
timeFrame: day 1
measure: Tanner stage
timeFrame: day 1
measure: Plasma glucose
timeFrame: day 1
measure: Total cholesterol
timeFrame: day 1
measure: High-density lipoprotein cholesterol
timeFrame: day 1
measure: Low-density lipoprotein cholesterol
timeFrame: day 1
measure: Triglyceride concentration
timeFrame: day 1
measure: C-reactive protein
timeFrame: day 1
measure: Serum leptin concentration
timeFrame: day 1
measure: Insulin
timeFrame: day 1
measure: Homeostatic model assessment for insulin resistance (HOMA-IR)
timeFrame: day 1
measure: Carbon dioxide output (VCO2) during exercise testing
timeFrame: day 1
measure: Minute ventilation(VE) during exercise testing
timeFrame: day 1
measure: Tidal volume (Vt) during exercise testing
timeFrame: day 1
measure: Breathing frequency (BF) during exercise testing
timeFrame: day 1
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Virga Jesse hospital - Heart centre Hasselt
state: Limburg
Study officials:
affiliation: Hasselt University
name: Dominique Hansen, PhD
role: PRINCIPAL_INVESTIGATOR
References: