Dysfunctional BreathingNCT04728191
The Effect of Physiotherapy on Dysfunctional Breathing in Children and Adolescents With and Without Asthma
A study testing Physiotherapy in people with Dysfunctional Breathing and Asthma in Children, run by Kolding Sygehus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Dysfunctional Breathing, Asthma in Children, Asthma
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Feb 2021to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Other significant cardiopulmonary or muscoluskeletal conditions.
- Complex functional conditions involving other organ systems.
- patients who already had the physotherapeutical intervention before study start.
Trial locations and contacts
1 site in 1 country.
Louise Jürgensen, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Signe Vahlkvist
Kolding, 6000
Signe Vahlkvist, PhD, Signe.Vahlkvist@rsyd.dk
Louise Jürgensen, MD, Anne.louise.Jürgensen@rsyd.dk
About this study
Official title: The Effect of Physiotherapy on Dysfunctional Breathing in Children and Adolescents With and Without Asthma.
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.
Read the 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.
- Conditions
- Dysfunctional Breathing, Asthma in Children, Asthma
- Being tested
- Physiotherapy, standard care
- Keywords
- Dysfunctional breathing, Asthma in children, Asthma in adolescents, Physiotherapy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
physiotherapeutical instructions and training as described.
standard careOther
Standard care as described.
| Study group | Role | What they receive |
|---|---|---|
| + asthma + intervention | Experimental | 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. Receives: Other: Physiotherapy |
| + asthma - intervention | Active comparator | 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. Receives: Other: standard care |
| - asthma + intervention | Experimental | 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. Receives: Other: Physiotherapy |
| - asthma - intervention | Active comparator | 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. Receives: Other: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Asthma Control Questionnaire ( ACQ5) at 6 months.
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. ACQ5 is taken by participants with asthma, at visits in the outpatient clinic.
Measured: ACQ is taken at baseline and 6 months after intervention as primary outcome.
Change from baseline in Pediatric Quality of Life Inventory ( PedsQl) at 6 months
PedsQl consists of 23 questions in 4 segments ( physical functioning, emotions, social interaction, and school activities). Each question is scored from 0 (best) to 4 (worst). The PedsQl questionnairre exists in formats for young children ( not used here), children aged 8-12 years and Teenagers aged 13-18 years. Children and adolescents are answering the age relevant questionnairre at visits in the out patient clinic. The PedsQl score is transformed to a 0-100 scale as follows: 0 =100, 1=75, 2=50, 3=25, 4=0. Health related Quality of life is calculated as a mean of scores. Psychosocial Health summary score is calculated as a mean of scores in the emotional, social and school functioning scales. Physical Health summary score is calculated as physical functioning scale score mean.
Measured: PedsQL is taken at baseline and 6 months after intervention as primary outcome.
Secondary outcomes (6)
Change from baseline in Nijmegen Questionnaire ( NQ)
NQ consists of 16 questions regarding dysfunctional breathing. Each question is scored between 0-4 points, where 0 is best and 4 is worst.
Measured: NQ is taken at baseline and 6 weeks, 6 months and 12 months after intervention.
Change from baseline in Brompton breathing Pattern Assesment Tool ( BBPAT)
BBPAT is a breathing scoring equipment where an observer is scoring the quality of breathing from seven parameters including respiratory rate, respiratory movements, in and expiratory sounds etc. Each parameter is scored from 0 ( best) to 2 ( worst). Total score is calculated between 0-14 point
Measured: BBPAT is taken at baseline and 6 weeks, 6 months and 12 months after intervention.
Number of contacts to the hospital during one year from baseline
Number of total contacts includes planned visits, extra visits and hospitalisations
Measured: from baseline to 12 months after intervention.
Change from baseline in Asthma Control Questionnaire ( ACQ5) at 6 weeks and one year. Change from 6 months in ACQ at 12 months.
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. ACQ5 is taken by participants with asthma in the outpatient clinic at baseline and after 6 weeks, 6 months and 12 months.
Measured: ACQ5 is taken at 6 weeks and 12 months after intervention as secondary outcomes.
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.
PedsQl consists of 23 questions in 4 segments ( physical functioning, emotions, social interaction, and school activities). Each question is scored from 0 (best) to 4 (worst). The PedsQl questionnairre exists in formats for young children ( not used here), children aged 10-13 years and Teenagers aged 13-18 years. Children and adolescents are answering the age relevant questionnairre at visits in the out patient clinic. The PedsQl score is transformed to a 0-100 scale as follows. 0 =100, 1=75, 2=50, 3=25, 4=0. Health related Quality of life is calculated as mean of scores. Psychosocial Health summary score is calculated as mean of scores in the emotional, social and school functioning scales. Physical Health summary score is calculated physical functioning scale score mean.
Measured: PedsQl is taken at 6 weeks and 12 months after intervention as secondary outcomes.
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.
Measured: at baseline and 6 weeks, 6 months and 12 months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start10 Feb 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunctional BreathingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kolding Sygehus
- Sponsor type
- University, hospital or other
- Collaborators
- Odense Patient Data Explorative Network
- Responsible party
- Principal investigator, Signe Vahlkvist, Kolding Sygehus
- Investigators
- Signe Vahlkvist, PhD, Principal investigator, Kolding Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728191
- Sponsor's protocol ID
- S-20200101-b
- Status last verified
- Mar 2023
- First submitted
- 21 Jan 2021
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie published results, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physiotherapy on Dysfunctional Breathing in Children and Adolescents With and Without Asthma.
- ClinicalTrials.gov ID
- NCT04728191
- Acronym / sponsor ID
- S-20200101-b
- Conditions
- Dysfunctional Breathing, Asthma in Children, Asthma
- Keywords
- Dysfunctional breathing, Asthma in children, Asthma in adolescents, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Kolding SygehusUniversity, hospital or other
- Collaborators
- Odense Patient Data Explorative Network
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| + asthma + intervention | Experimental | Other: Physiotherapy35 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. |
| + asthma - intervention | Active comparator | Other: standard care35 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. |
| - asthma + intervention | Experimental | Other: Physiotherapy35 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. |
| - asthma - intervention | Active comparator | Other: standard care35 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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Other significant cardiopulmonary or muscoluskeletal conditions.
- Complex functional conditions involving other organ systems.
- patients who already had the physotherapeutical intervention before study start.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapyphysiotherapeutical instructions and training as described. | Other | + asthma + intervention, - asthma + intervention |
| standard careStandard care as described. | Other | + asthma - intervention, - asthma - intervention |
Primary outcome
Change from baseline in Asthma Control Questionnaire ( ACQ5) at 6 months.
Time frame: ACQ is taken at baseline and 6 months after intervention as primary outcome.
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. ACQ5 is taken by participants with asthma, at visits in the outpatient clinic.
Change from baseline in Pediatric Quality of Life Inventory ( PedsQl) at 6 months
Time frame: PedsQL is taken at baseline and 6 months after intervention as primary outcome.
PedsQl consists of 23 questions in 4 segments ( physical functioning, emotions, social interaction, and school activities). Each question is scored from 0 (best) to 4 (worst). The PedsQl questionnairre exists in formats for young children ( not used here), children aged 8-12 years and Teenagers aged 13-18 years. Children and adolescents are answering the age relevant questionnairre at visits in the out patient clinic. The PedsQl score is transformed to a 0-100 scale as follows: 0 =100, 1=75, 2=50, 3=25, 4=0. Health related Quality of life is calculated as a mean of scores. Psychosocial Health summary score is calculated as a mean of scores in the emotional, social and school functioning scales. Physical Health summary score is calculated as physical functioning scale score mean.
6 secondary outcomes
Change from baseline in Nijmegen Questionnaire ( NQ)
Time frame: NQ is taken at baseline and 6 weeks, 6 months and 12 months after intervention.
Change from baseline in Brompton breathing Pattern Assesment Tool ( BBPAT)
Time frame: BBPAT is taken at baseline and 6 weeks, 6 months and 12 months after intervention.
Number of contacts to the hospital during one year from baseline
Time frame: from baseline to 12 months after intervention.
Change from baseline in Asthma Control Questionnaire ( ACQ5) at 6 weeks and one year. Change from 6 months in ACQ at 12 months.
Time frame: ACQ5 is taken at 6 weeks and 12 months after intervention as secondary outcomes.
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.
Time frame: PedsQl is taken at 6 weeks and 12 months after intervention as secondary outcomes.
The reported use of rescue Beta2 agonist in puffs per week
Time frame: at baseline and 6 weeks, 6 months and 12 months after intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie published results, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Jürgensen, MD contact
Signe Vahlkvist, PhD principal investigator
Kolding Sygehus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Dysfunctional Breathing and Asthma in Children, run by Kolding Sygehus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Signe Vahlkvist, PhD (+45 20 23 14 30, Signe.Vahlkvist@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Asthma Control Questionnaire ( ACQ5) at 6 months. (time frame: ACQ is taken at baseline and 6 months after intervention as primary outcome.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.