The Effect of Physiotherapy on Dysfunctional Breathing in Children and Adolescents With and Without Asthma

Kolding Sygehus

Status: Enrolling

Conditions: Asthma; Dysfunctional Breathing; Asthma in Children

Treatments: Other: Physiotherapy; Other: standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT04728191

S-20200101-b

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 4 patient groups

+ asthma + intervention

Experimental group

Description:

35 participants with asthma aged 10-17 years, randomized to physiotherapy. The intervention consists of 4 instruction lessons spread over 6 weeks. The participants are instructed in a daily ten-minute-program of breathing exercizes.

Treatment:

Other: Physiotherapy

+ asthma - intervention

Active Comparator group

Description:

35 participants with asthma aged 10-17 years, randomized to standard care. Participants are getting advice about dysfunctional breathing by a physician or nurse in the outpatient clinic.

Treatment:

Other: standard care

- asthma + intervention

Experimental group

Description:

35 participants without asthma aged 10-17 years, randomized to physiotherapy. The intervention consists of 4 instruction lessons spread over 6 weeks. The participants are instructed in a daily ten-minute-program of breathing exercizes.

Treatment:

Other: Physiotherapy

- asthma - intervention

Active Comparator group

Description:

35 participants without asthma, which are randomized to standard care. Participants are getting advise about dysfunctional breathing by a physician or nurse in the outpatient clinic.

Treatment:

Other: standard care