The Prevalence of Dysfunctional Breathing in Children and Adolescents With Asthma

Completed

• Conditions: Asthma; Dysfunctional Breathing; Asthma in Children

• Registration Number: NCT04734795
• Lead Sponsor: Kolding Sygehus

Brief Summary

The purpose of the study is to investigate the prevalence of dysfunctional breathing in children and adolescents with asthma in a hospital outpatient clinic.

Participants are invited to take the Nijmegen Questionnaire and the Asthma Control Questionnaire. The prevalence of dysfunctional breathing defined as NQ score \>= 23 is calculated, and demographics are compared between children with and without dysfunctional breathing.

Detailed Description

The purpose of the study is to investigate the prevalence of dysfunctional breathing in children and adolecents with asthma in a hospital outpatient clinic.

Participants are invited to take the Nijmegen Questionnaire and the Asthma Control Questionnaire, during appointments at the outpatient clinic. For this study purpose, each participant only takes the questionnairres once.

Patient data regarding age, sex, asthma medication, lung function, allergic sensitization, method of asthma diagnose, Height, weight and Body mass index is registered from the electronical patient journal.

The prevalence of dysfunctional breathing in the cohort is calculated as the fraction of children with a NQ score \>= 23.

The group of children and adolescents with dysfunctional breathing is characterized and compared to the group without dysfunctional breathing, regarding the descriptives mentioned above.

Study Timeline

• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-02
• Study Start: 2021-02-05
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-11
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 363

Inclusion Criteria

• Asthma diagnosed by lung function tests and/or typical symptoms.
• Treatment with inhaled corticosteroids in minimum 3 months.

Exclusion Criteria

• Other significant cardiopulmonary or muscoluskeletal conditions.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of children with dysfunctional breathing defined as Nijmegen Questionnaire ( NQ) Score >= 23	1 year	Nijmegen Questionnaire is a 16 point questionnairre addressing dysfunctional breathing. Each question is scored from 0 (best) to 4 (worst). NQ score is summarized between 0-64 points. NQ score \>= 23 predicts dysfunctional breathing.

Secondary Outcome Measures

Name	Time	Method
Method of asthma diagnose	1 year	Fraction of subjects where asthma was diagnosed objectively from lung function variability (reversibility to beta2 agonist OR positive exercise challenge OR positive mannitol challenge). Method of asthma diagnose is noted from the electronical patient journal
Age	1 year	Age in years of study subjects
Sex	1 year	Sex of study subjects
The reported use of rescue Beta2 agonist in puffs per week	1 year	The reported use of short acting beta 2 agonist in puffs per week the last week.
Forced expiratory volume inthe first second in percent of expected Value. ( FEV1%)	1 year	Spirometry is performed according to guidelines. FEV1% is calculated by the spirometry software.
Mask score	1 year	Because of the ongoing COVID19 pandemic, face mask is acquired in public, and many children are homeschooled. We therefore generated an 8 question survey about the frequency of wearing mask, breathing difficulties while wearing a mask, and weather there is a lock down of school and sports while survey is taken. Questions are scored from 0-3 points, where 0 is Best and 3 is worst
Asthma Control Questionnaire ( ACQ5)	1 year	ACQ5 contains 5 questions regarding asthma symptoms. Each question is scored between 0-6 points, where 0 represents very good asthma control and 6 represents poor asthma control. Total ACQ score is calculates as an average of points.
Standardised body mass index (BMI_SDS)	1 year	Body mass index is calculated as weight ( kg)/ Height ( m) \^2. As BMI changes with age, BMI standard deviation BMI_SDS is calculated from Danish Reference Material : (Tinggaard J, Aksglaede L, Sørensen K, et al (2014) The 2014 Danish references from birth to 20 years for height, weight and body mass index. Acta Paediatr Int J Paediatr. doi: 10.1111/apa.12468)

Trial Locations

Locations (1)

Kolding Sygehus; 🇩🇰 Kolding, Denmark