Cystic Fibrosis in ChildrenVOmucoNCT06242951
Cardiopulmonary Fitness in Children With Cystic Fibrosis Compared to Healthy Children
An observational study of Cystic Fibrosis in Children, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Cystic fibrosis is the most common severe genetic disease with autosomal recessive transmission in the Caucasian population. Its prognosis has improved considerably since the creation of Cystic Fibrosis centers (CF centers) and the improvement of symptomatic management (nutrition, antibiotic therapy, transplantation… Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Cystic Fibrosis in Children
- What is being tested?
- VO2 max assessment
- How many people
- 345 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2023to 30 Oct 2023
- 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 7 to 17 years
- All sexes
- Child
Study population: Children aged 7 to 17 years old recruited in the pediatric CPET laboratory of Montpellier University Hospital, France. Cases : children with cystic fibrosis Control : healthy children from a cohort already published (PMID: 29170358)
Who may be able to join
- Aged 7-17 years old
- Referred to the paediatric cardiopulmonary exercise test (CPET) laboratory of Montpellier University Hospital, France
- Have completed a CPET
- For cystic fibrosis group:
- To be followed up in the cystic fibrosis center of Montpellier University
- To be referred to our pediatrician CPET laboratory in 2019, or between July and December 2018 if they have not passed a CPET in 201
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- For control group:
- To be referred for non-severe functional symptoms linked to exercise (murmur, palpitation or dyspnea) or for medical sports certificate.
- Having a completely normal check-up, including physical examination, electrocardiogram, echocardiography and spirometry
Who cannot join
- Patients < 7 ou > 17 years old
- Absolute contraindication for CPET : fever, uncontrolled asthma, respiratory failure, acute myocarditis or pericarditis, uncontrolled arrhythmias causing symptoms or hemodynamic compromise, uncontrolled heart failure, acute pulmonary embolus or pulmonary infarction, and children with mental impairment leading to inability to cooperate
- Parents refuse the use of medical data
- For control group : children with any chronic disease, medical condition (cardiac, neurologic, respiratory, muscular, or renal), medical treatment, requiring any further specialized medical consultation or with any finding at clinical and paraclinical examination (electrocardiogram, echocardiography)
Trial locations and contacts
1 site in 1 country.
About this study
Cystic fibrosis is the most common severe genetic disease with autosomal recessive transmission in the Caucasian population.
Its prognosis has improved considerably since the creation of Cystic Fibrosis centers (CF centers) and the improvement of symptomatic management (nutrition, antibiotic therapy, transplantation, etc.). Thus, the median survival rate is now 46 years, whereas it was 5 years in 1963.
Read more
The current challenges for cystic fibrosis patients are therefore twofold:
to continue to improve their survival, and to improve their quality of life (QoL) to promote "healthy ageing" with this pathology that begins in childhood.
In 1980, the World Health Organization (WHO) stated that functional capacity explorations best reflected the impact of chronic disease on health-related quality of life. Impairment of physical activity is common to chronic diseases, as in cystic fibrosis, where respiratory impairment and denutrition have been shown to contribute to reduced exercise tolerance and increased dyspnoea.
Measurement of the maximum oxygen consumption (VO2max) by a cardiopulmonary exercise test (CPET) is regarded as the gold standard exercise test in the measurement of aerobic exercise capacity.
In 2005 Pianosi et al. found that for children with cystic fibrosis, the rate of decline of VO2max measured by CPET was predictive of poorer quality of life.
Continuing to study the determinants associated with impaired aerobic fitness in cystic fibrosis offers the hope of considering appropriate therapies to further improve the quality of life of these patients.
In recent years, the arrival and widespread use of CFTR protein modulators in children has been a real turning point and makes it possible to envisage a drastic change in the history of this disease and its prognosis in the long term.
Thus, in this study, the investigators aimed to assess the aerobic fitness, assessed by a CPET, of children with cystic fibrosis, and to compare the results with healthy controls. Secondly, investigators wanted to identify the predictive factors of VO2max in children with cystic fibrosis.
Read the detailed description
This retrospective study was carried out from November 2010 to September 2015 for control children (already published PubMed Identifier (PMID): 29170358) : and July 2018 to December 2019 for cystic fibrosis children.
CPET were performed in the paediatric CPET laboratory of Montpellier University Hospital, France.
Children aged 7 to 17 years old were recruited. Two groups were identified: children with cystic fibrosis and healthy control children.
- The cystic fibrosis group consisted of children followed up every three months in the cystic fibrosis center of Montpellier University and referred to our paediatrician CPET laboratory in 2019 in the framework of an annual check-up. For the few patients who did not have a CPET in 2019, investigators included those who passed a CPET between July and December 2018. From patients' interviews, the absence of any physical activity, apart from physical education at school, was indicative of sedentary lifestyle. Investigators also collected anthropometric data, radiological findings, CF-related markers of disease severity including cystic fibrosis transmembrane conductance regulator (CFTR) genotype, microbiological infection, pancreatic insufficiency, cystic fibrosis-related diabetes (CFRD), and treatment including modulator data.
- As in our previous similar CPET controlled paediatric studies, the control group consisted of children referred for non-severe functional symptoms linked to exercise (murmur, palpitation or dyspnoea) or for medical sports certificate. These children were classified as controls after a completely normal check-up, including physical examination, ECG, echocardiography and spirometry. Children with any chronic disease, medical condition (cardiac, neurologic, respiratory, muscular or renal), or medical treatment, and those requiring any further specialised medical consultation were not eligible.
CPET procedures were harmonized before the study started. Spirometry was systematically performed before the exercise test with a flow volume curve and measurement of forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and the FEV1/FVC ratio (FEV1/FVC), with normalization to Global Lung Function Initiative (GLI) 2012 Z scores. The same investigator coordinator manually calculated the VO2max and the ventilatory anaerobic threshold (VAT) using the V-Slope method. VO2max and VAT values were normalized in a percentage of the predicted VO2max using normal values from Wasserman and Cooper. The investigators considered VO2max below 80% of predicted value as pathologic value and a VAT value below 55 % of predicted VO2max was in favor of muscular deconditioning. All informations from CPET were recorded : heart rate (HR), blood pressure (BP), estimated VO2/HR, VAT, breathing reserves (BR), respiratory rate (RR), The minute ventilation/carbon dioxide production (VE/VCO2 slope), Tidal Volume (VT).
- Conditions
- Cystic Fibrosis in Children
- Being tested
- VO2 max assessment
- Keywords
- VO2 max, cardiopulmonary exercise test, physical fitness, pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VO2 max assessmentDiagnostic test
Measurement of the maximum oxygen consumption (VO2max) by a cardiopulmonary exercise test (CPET)
| Study group | Role | What they receive |
|---|---|---|
| Cystic fibrosis | Patients with cystic fibrosis Receives: Diagnostic Test: VO2 max assessment | |
| Control | Not described Receives: Diagnostic Test: VO2 max assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum oxygen volume by min (VO2 max) assessed by cardiopulmonary exercise test (CPET)
Measured: up to 30 oct 2023
Secondary outcomes (1)
Determinants of maximum oxygen volume by min
Assess whether there are determinants that can explain an alteration in vo2max among : anthropometric data, CF-related markers of disease severity including CFTR genotype, pulmonary function test, microbiological data, BHALLA score, pancreatic insufficiency, cystic fibrosis-related diabetes (CFRD), hepatic injury, polyposis, treatments
Measured: up to 30 oct 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start31 Jan 2023
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis in ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johan MOREAU, MD, Principal investigator, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242951
- Sponsor's protocol ID
- IRB-MTP_2023_01_202201310
- Acronym
- VOmuco
- Status last verified
- Dec 2023
- First submitted
- 22 Dec 2023
- Last updated
- 15 Feb 2024
- 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 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Fitness in Children With Cystic Fibrosis Compared to Healthy Children
- ClinicalTrials.gov ID
- NCT06242951
- Acronym / sponsor ID
- VOmuco / IRB-MTP_2023_01_202201310
- Conditions
- Cystic Fibrosis in Children
- Keywords
- VO2 max, cardiopulmonary exercise test, physical fitness, pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 5 Feb 2024 (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.
Cystic fibrosis is the most common severe genetic disease with autosomal recessive transmission in the Caucasian population.
Its prognosis has improved considerably since the creation of Cystic Fibrosis centers (CF centers) and the improvement of symptomatic management (nutrition, antibiotic therapy, transplantation, etc.). Thus, the median survival rate is now 46 years, whereas it was 5 years in 1963.
The current challenges for cystic fibrosis patients are therefore twofold:
to continue to improve their survival, and to improve their quality of life (QoL) to promote "healthy ageing" with this pathology that begins in childhood.
In 1980, the World Health Organization (WHO) stated that functional capacity explorations best reflected the impact of chronic disease on health-related quality of life. Impairment of physical activity is common to chronic diseases, as in cystic fibrosis, where respiratory impairment and denutrition have been shown to contribute to reduced exercise tolerance and increased dyspnoea.
Measurement of the maximum oxygen consumption (VO2max) by a cardiopulmonary exercise test (CPET) is regarded as the gold standard exercise test in the measurement of aerobic exercise capacity.
In 2005 Pianosi et al. found that for children with cystic fibrosis, the rate of decline of VO2max measured by CPET was predictive of poorer quality of life.
Continuing to study the determinants associated with impaired aerobic fitness in cystic fibrosis offers the hope of considering appropriate therapies to further improve the quality of life of these patients.
In recent years, the arrival and widespread use of CFTR protein modulators in children has been a real turning point and makes it possible to envisage a drastic change in the history of this disease and its prognosis in the long term.
Thus, in this study, the investigators aimed to assess the aerobic fitness, assessed by a CPET, of children with cystic fibrosis, and to compare the results with healthy controls. Secondly, investigators wanted to identify the predictive factors of VO2max in children with cystic fibrosis.
Detailed description
This retrospective study was carried out from November 2010 to September 2015 for control children (already published PubMed Identifier (PMID): 29170358) : and July 2018 to December 2019 for cystic fibrosis children.
CPET were performed in the paediatric CPET laboratory of Montpellier University Hospital, France.
Children aged 7 to 17 years old were recruited. Two groups were identified: children with cystic fibrosis and healthy control children.
- The cystic fibrosis group consisted of children followed up every three months in the cystic fibrosis center of Montpellier University and referred to our paediatrician CPET laboratory in 2019 in the framework of an annual check-up. For the few patients who did not have a CPET in 2019, investigators included those who passed a CPET between July and December 2018. From patients' interviews, the absence of any physical activity, apart from physical education at school, was indicative of sedentary lifestyle. Investigators also collected anthropometric data, radiological findings, CF-related markers of disease severity including cystic fibrosis transmembrane conductance regulator (CFTR) genotype, microbiological infection, pancreatic insufficiency, cystic fibrosis-related diabetes (CFRD), and treatment including modulator data.
- As in our previous similar CPET controlled paediatric studies, the control group consisted of children referred for non-severe functional symptoms linked to exercise (murmur, palpitation or dyspnoea) or for medical sports certificate. These children were classified as controls after a completely normal check-up, including physical examination, ECG, echocardiography and spirometry. Children with any chronic disease, medical condition (cardiac, neurologic, respiratory, muscular or renal), or medical treatment, and those requiring any further specialised medical consultation were not eligible.
CPET procedures were harmonized before the study started. Spirometry was systematically performed before the exercise test with a flow volume curve and measurement of forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and the FEV1/FVC ratio (FEV1/FVC), with normalization to Global Lung Function Initiative (GLI) 2012 Z scores. The same investigator coordinator manually calculated the VO2max and the ventilatory anaerobic threshold (VAT) using the V-Slope method. VO2max and VAT values were normalized in a percentage of the predicted VO2max using normal values from Wasserman and Cooper. The investigators considered VO2max below 80% of predicted value as pathologic value and a VAT value below 55 % of predicted VO2max was in favor of muscular deconditioning. All informations from CPET were recorded : heart rate (HR), blood pressure (BP), estimated VO2/HR, VAT, breathing reserves (BR), respiratory rate (RR), The minute ventilation/carbon dioxide production (VE/VCO2 slope), Tidal Volume (VT).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystic fibrosis | – | Diagnostic Test: VO2 max assessmentPatients with cystic fibrosis |
| Control | – | Diagnostic Test: VO2 max assessment |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Children aged 7 to 17 years old recruited in the pediatric CPET laboratory of Montpellier University Hospital, France. Cases : children with cystic fibrosis Control : healthy children from a cohort already published (PMID: 29170358)
Key inclusion criteria (9 listed)
- Aged 7-17 years old
- Referred to the paediatric cardiopulmonary exercise test (CPET) laboratory of Montpellier University Hospital, France
- Have completed a CPET
- To be followed up in the cystic fibrosis center of Montpellier University
- To be referred to our pediatrician CPET laboratory in 2019, or between July and December 2018 if they have not passed a CPET in 201
Key exclusion criteria (4 listed)
- Patients < 7 ou > 17 years old
- Absolute contraindication for CPET : fever, uncontrolled asthma, respiratory failure, acute myocarditis or pericarditis, uncontrolled arrhythmias causing symptoms or hemodynamic compromise, uncontrolled heart failure, acute pulmonary embolus or pulmonary infarction, and children with mental impairment leading to inability to cooperate
- Parents refuse the use of medical data
- For control group : children with any chronic disease, medical condition (cardiac, neurologic, respiratory, muscular, or renal), medical treatment, requiring any further specialized medical consultation or with any finding at clinical and paraclinical examination (electrocardiogram, echocardiography)
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 |
|---|---|---|
| VO2 max assessmentMeasurement of the maximum oxygen consumption (VO2max) by a cardiopulmonary exercise test (CPET) | Diagnostic test | Control, Cystic fibrosis |
Primary outcome
Maximum oxygen volume by min (VO2 max) assessed by cardiopulmonary exercise test (CPET)
Time frame: up to 30 oct 2023
1 secondary outcome
Determinants of maximum oxygen volume by min
Time frame: up to 30 oct 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- 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.
Johan MOREAU, MD principal investigator
UH Montpellier
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 Cystic Fibrosis in Children, run by University Hospital, Montpellier at 1 site in France.
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 9 inclusion and 4 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: finished, as of the sponsor's last update on 15 Feb 2024. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum oxygen volume by min (VO2 max) assessed by cardiopulmonary exercise test (CPET) (time frame: up to 30 oct 2023). 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 15 Feb 2024.