Chronotropic Incompetence During Exercise Testing in Obese Adolescents

Chronotropic Incompetence During Cardiopulmonary Exercise Testing in Obese Adolescents: Associations With Caridometabolic Health

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.

Study Overview

• Status: Unknown
• Conditions: Obesity, Childhood; Cardiovascular Risk Factor; Cardiac Disease
• Intervention / Treatment: Diagnostic test: The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Recruiting
      • Virga Jesse hospital - Heart centre Hasselt
      • Contact: Dominique Hansen, prof. dr.; Phone Number: +32 11 29 21 26; Email: dominique.hansen@uhasselt.be
      • Sub-Investigator: Wouter Franssen, MSc
      • Sub-Investigator: Charly Keytsman, Dr.
      • Sub-Investigator: Nastasia Marinus, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Obese adolescents

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obese adolescents with CI; Obese adolescents with chronotropic incompetence	Diagnostic test: The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing; The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing
Control group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate (HR) during exercise testing	Assessed using a 12-lead ECG device	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.	day 1
Peak workload during exercise testing	Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed and the incremental workload is measured	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body height	Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot	day 1
Body weight	Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg	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.	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.	day1
Physical activity questionnaire for adolescents (PAQ-A)	physical activity determined using the validated Dutch physical activity questionnaire for adolescents	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.	day 1
Plasma glucose	Blood analyses	day 1
Total cholesterol	Blood analyses	day 1
High-density lipoprotein cholesterol	Blood analyses	day 1
Low-density lipoprotein cholesterol	Blood analyses	day 1
Triglyceride concentration	Blood analyses	day 1
C-reactive protein	Blood analyses	day 1
Serum leptin concentration	Blood analyses	day 1
Insulin	Blood analyses	day 1
Homeostatic model assessment for insulin resistance (HOMA-IR)	Homeostatic model assessment for insulin resistance calculated from insulin and glucose concentration	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.	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.	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.	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.	day 1

Collaborators and Investigators

• Sponsor: Hasselt University
• Investigators: Principal Investigator: Dominique Hansen, PhD, Hasselt University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 29, 2019
• Primary Completion (Anticipated): January 15, 2020
• Study Completion (Anticipated): January 30, 2020

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): December 4, 2019
• Last Update Submitted That Met QC Criteria: December 2, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Heart Diseases; Pediatric Obesity
• Other Study ID Numbers: CIDCET study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No