Chronotropic Incompetence During Exercise Testing in Obese Adolescents

Cardiovascular Risk Factor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04185753
• Other study ID #: CIDCET study
• Status: Recruiting
• Start date: November 29, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: December 2019
• Source: Hasselt University
• Contact: Dominique Hansen, Prof.
• Phone: +32(0)11 292126
• Email: dominique.hansen[@]uhasselt.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 30, 2020
• Est. primary completion date: January 15, 2020
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Cardiovascular Risk Factor
• Heart Diseases
• Obesity, Childhood
• Pediatric Obesity

Intervention

Diagnostic Test:
• The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing
The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing

Locations

Country	Name	City	State
Belgium	Virga Jesse hospital - Heart centre Hasselt	Hasselt	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate (HR) during exercise testing	Assessed using a 12-lead ECG device	day 1
Primary	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
Primary	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	Body height	Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot	day 1
Secondary	Body weight	Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg	day 1
Secondary	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
Secondary	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
Secondary	Physical activity questionnaire for adolescents (PAQ-A)	physical activity determined using the validated Dutch physical activity questionnaire for adolescents	day 1
Secondary	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
Secondary	Plasma glucose	Blood analyses	day 1
Secondary	Total cholesterol	Blood analyses	day 1
Secondary	High-density lipoprotein cholesterol	Blood analyses	day 1
Secondary	Low-density lipoprotein cholesterol	Blood analyses	day 1
Secondary	Triglyceride concentration	Blood analyses	day 1
Secondary	C-reactive protein	Blood analyses	day 1
Secondary	Serum leptin concentration	Blood analyses	day 1
Secondary	Insulin	Blood analyses	day 1
Secondary	Homeostatic model assessment for insulin resistance (HOMA-IR)	Homeostatic model assessment for insulin resistance calculated from insulin and glucose concentration	day 1
Secondary	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
Secondary	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
Secondary	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
Secondary	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