Chronotropic Incompetence During Exercise Testing in Obese Adolescents

NCT ID: NCT04185753

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-29
• Study Completion Date: 2020-01-30

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.

Conditions

Obesity, Childhood; Cardiac Disease; Cardiovascular Risk Factor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Obese adolescents with CI

Obese adolescents with chronotropic incompetence

The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing

Intervention Type: DIAGNOSTIC_TEST

The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing

Control group

Obese adolescents without chronotropic incompetence

The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing

Intervention Type: DIAGNOSTIC_TEST

The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing

Interventions

The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing

The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

Dominique Hansen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dominique Hansen, PhD

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Locations

Virga Jesse hospital - Heart centre Hasselt

Hasselt, Limburg, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Dominique Hansen, Prof.

Role: CONTACT

dominique.hansen@uhasselt.be

+32(0)11 292126

Facility Contacts

Dominique Hansen, prof. dr.

Role: primary

dominique.hansen@uhasselt.be

+32 11 29 21 26

Other Identifiers

CIDCET study

Identifier Type: -

Identifier Source: org_study_id