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Obesity, ChildhoodNCT04185753

Chronotropic Incompetence During Exercise Testing in Obese Adolescents

An observational study of Obesity, Childhood and Cardiac Disease, run by Hasselt University at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 11 to 17 years
What is being tested?
The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing
How many people
60 participants
Where
1 siteBelgium
Study dates
29 Nov 2019to 30 Jan 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 17 years
  • All sexes
  • Child

Study population: Obese adolescents

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Dominique Hansen, Prof. contact

+32(0)11 292126

dominique.hansen@uhasselt.be

Belgium1 site, 1 recruiting
  • Virga Jesse hospital - Heart centre Hasselt

    Hasselt, Limburg, 3500

    Dominique Hansen, prof. dr., +32 11 29 21 26, dominique.hansen@uhasselt.be

    Wouter Franssen, MSc

    Recruiting

Other trials in Belgium

About this study

Official title: 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.

Being tested
The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing
Medical subject headings
Pediatric Obesity, Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testingDiagnostic test

    The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing

Study groups in NCT04185753
Study groupRoleWhat they receive
Obese adolescents with CIObese adolescents with chronotropic incompetence
Receives: Diagnostic Test: The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing
Control groupObese adolescents without chronotropic incompetence
Receives: Diagnostic Test: The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart rate (HR) during exercise testing

    Assessed using a 12-lead ECG device

    Measured: day 1

  2. 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.

    Measured: day 1

  3. Peak workload during exercise testing

    Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed and the incremental workload is measured

    Measured: day 1

Secondary outcomes (19)
  1. Body height

    Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot

    Measured: day 1

  2. Body weight

    Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg

    Measured: day 1

  3. 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.

    Measured: day 1

  4. 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.

    Measured: day1

  5. Physical activity questionnaire for adolescents (PAQ-A)

    physical activity determined using the validated Dutch physical activity questionnaire for adolescents

    Measured: day 1

  6. Tanner stage

    Puberty stage (ranging from 1 to 5) will be assessed in all participants by the pediatric endocrinologist using Tanner staging criteria.

    Measured: day 1

  7. Plasma glucose

    Blood analyses

    Measured: day 1

  8. Total cholesterol

    Blood analyses

    Measured: day 1

  9. High-density lipoprotein cholesterol

    Blood analyses

    Measured: day 1

  10. Low-density lipoprotein cholesterol

    Blood analyses

    Measured: day 1

  11. Triglyceride concentration

    Blood analyses

    Measured: day 1

  12. C-reactive protein

    Blood analyses

    Measured: day 1

  13. Serum leptin concentration

    Blood analyses

    Measured: day 1

  14. Insulin

    Blood analyses

    Measured: day 1

  15. Homeostatic model assessment for insulin resistance (HOMA-IR)

    Homeostatic model assessment for insulin resistance calculated from insulin and glucose concentration

    Measured: day 1

  16. 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.

    Measured: day 1

  17. 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.

    Measured: day 1

  18. 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.

    Measured: day 1

  19. 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.

    Measured: day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2019
  2. Study start29 Nov 2019 (estimated)
  3. Primary completion15 Jan 2020 (estimated)
  4. Study completion30 Jan 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04185753
Sponsor's protocol ID
CIDCET study
Status last verified
Dec 2019
First submitted
27 Nov 2019
Last updated
4 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, Childhood and Cardiac Disease, run by Hasselt University at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dominique Hansen, Prof. (+32(0)11 292126, dominique.hansen@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart rate (HR) during exercise testing (time frame: day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2019.

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