The Prevalence of Dysfunctional Breathing in Children and Adolescents With Asthma

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Asthma in Children; 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 Type: Observational
• Enrollment (Actual): 363

Contacts and Locations

Study Locations

• Denmark
  • Kolding, Denmark, 6000
    • Kolding Sygehus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children and adolecents with asthma in a hospital outpatient clinic

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of children with dysfunctional breathing defined as Nijmegen Questionnaire ( NQ) Score >= 23	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mask score	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	1 year
Asthma Control Questionnaire ( ACQ5)	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.	1 year
Age	Age in years of study subjects	1 year
Sex	Sex of study subjects	1 year
Standardised body mass index (BMI_SDS)	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)	1 year
The reported use of rescue Beta2 agonist in puffs per week	The reported use of short acting beta 2 agonist in puffs per week the last week.	1 year
Forced expiratory volume inthe first second in percent of expected Value. ( FEV1%)	Spirometry is performed according to guidelines. FEV1% is calculated by the spirometry software.	1 year
Method of asthma diagnose	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	1 year

Collaborators and Investigators

• Sponsor: Kolding Sygehus
• Collaborators: Odense Patient Data Explorative Network
• Investigators: Principal Investigator: Signe Vahlkvist, Kolding Sygehus

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 5, 2021
• Primary Completion (ACTUAL): May 1, 2022
• Study Completion (ACTUAL): May 1, 2022

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (ACTUAL): February 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Dysfunctional breathing; Asthma in children; Asthma in adolescents
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Respiratory Aspiration; Asthma
• Other Study ID Numbers: S-2020-0101-a

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie published results, after deidentification.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed to Open@rsyd.dk.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No