Cardiopulmonary Fitness in Children With Asthma Versus Healthy Children

NCT04650464 | Completed

• 1 other identifier: RECHMPL20_0022
• Study Type: observational
• Target: 446
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma is the most common chronic disease in children worldwide. Asthma is characterised by a chronic inflammatory disorder of the airways,episodes of wheezing, breathlessness, chest tightness and coughing. There is a large variability of asthma prevalence between countries from 11 to 15% for children in developed countries. Asthma may limit the patient's ability to be physically active and can lead to a sedentary lifestyle and affect patients' quality of life. Indeed, long-term goal of asthma management as any chronic disease is to control symptoms in order to ensure a normal quality of life to children with asthma In 1980, the World Health Organization stated that functional capacity explorations best reflect the impact of a chronic disease on the quality of life. Indeed, cardiopulmonary exercise test (CPET) has become the "gold standard" in functional evaluation of cardiorespiratory diseases in adults gradually extended to children. Physical fitness is evaluated by maximal oxygen uptake "VO2 max" during a CPET. CPET also allows to determine possible limiting factors (cardiac limitation, ventilatory limitation, muscular deconditioning) responsible for a lower VO2max. There is actually contradictory evidence regarding the aerobic fitness levels of asthmatic children and it remains unclear whether significant differences exist between asthmatic children and their non-asthmatic counterparts. Few studies suggest ventilatory exercise limitations linked to the severity of bronchial obstruction whether others put in light the impact of muscular deconditioning in the asthmatic population. In this context, the investigators aimed to compare the cardiopulmonary fitness of children with asthma with that of age-adjusted and gender-adjusted controls. The investigators also intended to identify clinical characteristics associated with VO2max in this population.

Conditions

Asthmatic

Keywords

Asthmatic children; VO2 max; Physical fitness; Peadiarics

Outcome Measures

Primary Outcomes (1)

• Comparison cardiopulmonary fitness in children with asthma versus healthy children

  Comparison VO2max in children with asthma versus healthy children.

  1 day

Secondary Outcomes (2)

• Comparison of others CPET in children

  1 day

• Variation of VO2max in asthmatic children

  1 day

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children aged 5 to 18 years old recruited in one of the 2 CPET laboratories after a regular paediatric cardiology outpatient visit. Cases : children with asthma Control : healthy children from a cohort already published (PMID: 29170358)

You may qualify if:

• Children aged 5 to 18 years old recruited in one of the 2 CPET laboratories after a regular paediatric cardiology outpatient visit.
• The asthma group consisted of children followed for asthma by any pediatrician or pulmonologist and referred to one of the 2 CPET laboratories.
• The control group consisted of children referred for a non-severe functional symptom linked to exercise (murmur, palpitation, or dyspnoea) or for a medical sports certificate.

You may not qualify if:

• patients \<5 years or 1,2m, patients \>18 ans
• absolute contraindications : fever, uncontrolled asthma, respiratory failure, acute myocarditis or pericarditis, uncontrolled arrhythmias causing symptoms or haemodynamic 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 the 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

Related Publications (1)

• Moreau J, Socchi F, Renoux MC, Requirand A, Abassi H, Guillaumont S, Matecki S, Huguet H, Avesani M, Picot MC, Amedro P. Cardiopulmonary fitness in children with asthma versus healthy children. Arch Dis Child. 2023 Mar;108(3):204-210. doi: 10.1136/archdischild-2021-323733. Epub 2022 Nov 29.

  PMID: 36446481 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Johan Moreau, MD

  UH MONTPELLIER

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: December 2, 2020
• Study Start: November 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: December 30, 2019
• Last Updated: December 2, 2020

Record last verified: 2020-10

Locations

FR (1)