The Effect of Physiotherapy on Dysfunctional Breathing in Children and Adolescents With and Without Asthma
NCT ID: NCT04728191
Last Updated: 2023-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2021-02-10
2024-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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+ asthma + intervention
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.
Physiotherapy
physiotherapeutical instructions and training as described.
+ asthma - intervention
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.
standard care
Standard care as described.
- asthma + intervention
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.
Physiotherapy
physiotherapeutical instructions and training as described.
- asthma - intervention
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.
standard care
Standard care as described.
Interventions
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Physiotherapy
physiotherapeutical instructions and training as described.
standard care
Standard care as described.
Eligibility Criteria
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Inclusion Criteria
* 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
* Complex functional conditions involving other organ systems.
* patients who already had the physotherapeutical intervention before study start.
10 Years
17 Years
ALL
No
Sponsors
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Odense Patient Data Explorative Network
OTHER
Kolding Sygehus
OTHER
Responsible Party
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Signe Vahlkvist
Principal Investigator
Principal Investigators
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Signe Vahlkvist, PhD
Role: PRINCIPAL_INVESTIGATOR
Kolding Sygehus
Locations
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Signe Vahlkvist
Kolding, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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S-20200101-b
Identifier Type: -
Identifier Source: org_study_id
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