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.
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
- Conditions the study is for
- Obesity, Childhood, Cardiac Disease, Cardiovascular Risk Factor
- 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.
Belgium1 site, 1 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| Obese adolescents with CI | Obese adolescents with chronotropic incompetence Receives: Diagnostic Test: The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing | |
| Control group | Obese 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.
Heart rate (HR) during exercise testing
Assessed using a 12-lead ECG device
Measured: 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.
Measured: day 1
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)
Body height
Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot
Measured: day 1
Body weight
Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg
Measured: 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.
Measured: 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.
Measured: day1
Physical activity questionnaire for adolescents (PAQ-A)
physical activity determined using the validated Dutch physical activity questionnaire for adolescents
Measured: 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.
Measured: day 1
Plasma glucose
Blood analyses
Measured: day 1
Total cholesterol
Blood analyses
Measured: day 1
High-density lipoprotein cholesterol
Blood analyses
Measured: day 1
Low-density lipoprotein cholesterol
Blood analyses
Measured: day 1
Triglyceride concentration
Blood analyses
Measured: day 1
C-reactive protein
Blood analyses
Measured: day 1
Serum leptin concentration
Blood analyses
Measured: day 1
Insulin
Blood analyses
Measured: day 1
Homeostatic model assessment for insulin resistance (HOMA-IR)
Homeostatic model assessment for insulin resistance calculated from insulin and glucose concentration
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start29 Nov 2019 (estimated)
- Primary completion15 Jan 2020 (estimated)
- Study completion30 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominique Hansen, Hasselt University
- Investigators
- Dominique Hansen, PhD, Principal investigator, Hasselt University
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronotropic Incompetence During Cardiopulmonary Exercise Testing in Obese Adolescents: Associations With Caridometabolic Health
- ClinicalTrials.gov ID
- NCT04185753
- Acronym / sponsor ID
- CIDCET study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 29 Nov 2019 (estimated)
- Primary completion
- 15 Jan 2020 (estimated)
- Study completion
- 30 Jan 2020 (estimated)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese adolescents with CI | – | Diagnostic Test: The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testingObese adolescents with chronotropic incompetence |
| Control group | – | Diagnostic Test: The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testingObese adolescents without chronotropic incompetence |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Obese adolescents
Key inclusion criteria (2 listed)
- obese or lean (based on extended international (IOTF) body mass index cut-offs for thinness, overweight and obesity)
- Parental permission
Key exclusion criteria (2 listed)
- Chronic cardiovascular, renal, pulmonary or orthopaedic disease
- Medication use that could possibly influence the heart rate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testingThe prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing | Diagnostic test | Control group, Obese adolescents with CI |
Primary outcome
Heart rate (HR) during exercise testing
Time frame: day 1
Assessed using a 12-lead ECG device
Peak oxygen uptake (VO2) during exercise testing
Time frame: day 1
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.
Peak workload during exercise testing
Time frame: day 1
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed and the incremental workload is measured
19 secondary outcomes
Body height
Time frame: day 1
Body weight
Time frame: day 1
Waist circumference
Time frame: day 1
Hip circumference
Time frame: day1
Physical activity questionnaire for adolescents (PAQ-A)
Time frame: day 1
Tanner stage
Time frame: day 1
Plasma glucose
Time frame: day 1
Total cholesterol
Time frame: day 1
High-density lipoprotein cholesterol
Time frame: day 1
Low-density lipoprotein cholesterol
Time frame: day 1
Triglyceride concentration
Time frame: day 1
C-reactive protein
Time frame: day 1
Serum leptin concentration
Time frame: day 1
Insulin
Time frame: day 1
Homeostatic model assessment for insulin resistance (HOMA-IR)
Time frame: day 1
Carbon dioxide output (VCO2) during exercise testing
Time frame: day 1
Minute ventilation(VE) during exercise testing
Time frame: day 1
Tidal volume (Vt) during exercise testing
Time frame: day 1
Breathing frequency (BF) during exercise testing
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Hansen, PhD principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
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.