Clinical trial NCT04728191: The Effect of Physiotherapy on Dysfunctional Breathing in Children and Adolescents With and Without Asthma
Official title: The Effect of Physiotherapy on Dysfunctional Breathing in Children and Adolescents With and Without Asthma.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysfunctional Breathing
Asthma in Children
Asthma
Keywords: Dysfunctional breathing
Asthma in children
Asthma in adolescents
Physiotherapy
Lead sponsor: Kolding Sygehus
Sponsor class: OTHER
Collaborators: name: Odense Patient Data Explorative Network
First posted: 2021-01-28
Enrollment: 140
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the effect of physiotherapeutical instructions on dysfunctional breathing in children and adolescents with or without asthma.

Children and adolescents with dysfunctional breathing, are invited to participate in the intervention study. Participants are stratified by asthma diagnose status and randomized to physiotherapy or standard care. Participants are followed a year after the intervention, to compare the development in asthma control ( if asthma) and quality of life.

Detailed description: The purpose of the study is to investigate the effect of physiotherapeutical instructions on dysfunctional breathing in children and adolescents with or without asthma.

All children and adolescents aged 10-17 years, followed in our outpatient clinic with the diagnose of asthma are invited to fulfill the Nijmegen Questionnaire (NQ) and the Asthma Control Questionnaire (ACQ5)

Children and adolescents where asthma was investigated and ruled out are invited to fulfill the NQ.

Data from the electronic patient journal are used as descriptives.

Participants with dysfunctional breathing (NQ \>= 23) are invited to participate in the intervention study. Participants are stratified by asthma diagnose status and randomized to physiotherapy or standard care. Participants are followed a year after the intervention, to compare the development in asthma control measured by ACQ5 (if asthma) and quality of life measured by PedsQL.

The effect of physiotherapy is analyzed separately for participants with and without asthma. In addition, primary outcomes are analyzed in a regression model with asthma status, age and sex as explanatory variables.

Eligibility criteria: Inclusion Criteria:

Asthma group:

* Asthma diagnosed by lung function tests and/or typical symptoms.
* Treatment with inhaled corticosteroids in minimum 3 months.
* ACQ5 \>= 1.5.
* NQ \>= 23.

NonAsthma group

* Asthma denied after lung function tests ( exercise challenge or mannitol challenge)
* NQ \>= 23.

Exclusion Criteria:

* Other significant cardiopulmonary or muscoluskeletal conditions.
* Complex functional conditions involving other organ systems.
* patients who already had the physotherapeutical intervention before study start.

Primary outcomes:
measure: Change from baseline in Asthma Control Questionnaire ( ACQ5) at 6 months.
timeFrame: ACQ is taken at baseline and 6 months after intervention as primary outcome.
measure: Change from baseline in Pediatric Quality of Life Inventory ( PedsQl) at 6 months
timeFrame: PedsQL is taken at baseline and 6 months after intervention as primary outcome.
Secondary outcomes:
measure: Change from baseline in Nijmegen Questionnaire ( NQ)
timeFrame: NQ is taken at baseline and 6 weeks, 6 months and 12 months after intervention.
measure: Change from baseline in Brompton breathing Pattern Assesment Tool ( BBPAT)
timeFrame: BBPAT is taken at baseline and 6 weeks, 6 months and 12 months after intervention.
measure: Number of contacts to the hospital during one year from baseline
timeFrame: from baseline to 12 months after intervention.
measure: Change from baseline in Asthma Control Questionnaire ( ACQ5) at 6 weeks and one year. Change from 6 months in ACQ at 12 months.
timeFrame: ACQ5 is taken at 6 weeks and 12 months after intervention as secondary outcomes.
measure: Change from baseline in Pediatric Quality of Life Inventory ( PedsQl) at at 6 weeks and one year. Change from 6 months in PedsQl at 12 months.
timeFrame: PedsQl is taken at 6 weeks and 12 months after intervention as secondary outcomes.
measure: The reported use of rescue Beta2 agonist in puffs per week
timeFrame: at baseline and 6 weeks, 6 months and 12 months after intervention.
Other outcomes:
Locations:
city: Kolding
country: Denmark
facility: Signe Vahlkvist
Study officials:
affiliation: Kolding Sygehus
name: Signe Vahlkvist, PhD
role: PRINCIPAL_INVESTIGATOR
References: