Cardiopulmonary Fitness in Children With Cystic Fibrosis Compared to Healthy Children

NCT06242951 | Completed

• 1 other identifier: IRB-MTP_2023_01_202201310
• Study Type: observational
• Target: 345
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Cystic Fibrosis in Children

Keywords

VO2 max; cardiopulmonary exercise test; physical fitness; pediatrics

Outcome Measures

Primary Outcomes (1)

• Maximum oxygen volume by min (VO2 max) assessed by cardiopulmonary exercise test (CPET)

  up to 30 oct 2023

Secondary Outcomes (1)

• Determinants of maximum oxygen volume by min

  up to 30 oct 2023

Study Arms (2)

Cystic fibrosis

Patients with cystic fibrosis

Diagnostic Test: VO2 max assessment

Control

Diagnostic Test: VO2 max assessment

Interventions

VO2 max assessment DIAGNOSTIC_TEST

Measurement of the maximum oxygen consumption (VO2max) by a cardiopulmonary exercise test (CPET)

Control; Cystic fibrosis

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

UH Montpellier

Montpellier, 34295, France

Location

Study Officials

• Johan MOREAU, MD

  UH Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: February 5, 2024
• Study Start: January 31, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: February 15, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)