Dysfunctional BreathingPhysDBNCT04215341
Physiotherapy for Children With Dysfunctional Breathing
A study testing Physiotherapy in people with Dysfunctional Breathing, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Dysfunctional breathing in children primarily affects the ability to participate in sport or exercise but can also stop children doing other activities such as playing musical instruments. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Dysfunctional Breathing
- What is being tested?
- Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Aug 2014to 8 Aug 2016
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 8-16 years Clinical diagnosis of dysfunctional breathing
Who cannot join
- Uncontrolled comorbidities Participant and parents/guardians not fluent in written and spoken English Inability to follow instructions
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Children's NHS Foundation Trust
Sheffield, Sheffield (South Yorkshire District), S10 2TH
About this study
Official title: Feasibility Study for a Multi-centre Trial Investigating Whether Physiotherapy Improves Outcomes for Children With Dysfunctional Breathing
Dysfunctional breathing in children primarily affects the ability to participate in sport or exercise but can also stop children doing other activities such as playing musical instruments. Clinical experience has shown that physiotherapy (through the use of breathing retraining and other associated techniques) can stop the symptoms of dysfunctional breathing, allowing children to return to normal activities and reduce or stop inhaled medications.
Whilst there is some evidence in adults with this condition to support the use of physiotherapy, there have been no studies carried out in children investigating whether physiotherapy is beneficial for children with dysfunctional breathing.
This study therefore aims to investigate the feasibility of a future large scale multicentre clinical trial designed to investigate whether physiotherapy improves outcomes for children with dysfunctional breathing. The improved management of this common but under recognised condition would lead to significant improvements in the quality of life of children coupled with the reduction in potentially harmful medications.
- Conditions
- Dysfunctional Breathing
- Being tested
- Physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyBehavioural
Also called None - Inhalers and scans are not interventions
A course of breathing retraining delivered by a physiotherapist and practiced by the participant at home.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The study contains a single arm. All children participating in the study will receive the primary intervention which is physiotherapy. Receives: Behavioral: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child and parent proxy report versions of the quality of life questionnaire(PedsQL)
To measure participant and parent proxy report of quality of life in the four domains of physical, emotional, social and school functioning
Measured: 24 months
Secondary outcomes (3)
Symptom questionnaire (Nijmegen questionnaire)
To measure the type and frequency of symptoms commonly associated with dysfunctional breathing
Measured: 24 months
Structured light plethysmography (SLP) scan (Thora-3DI)
To objectively measure breathing pattern and rate without influencing these parameters
Measured: 24 months
Reliever inhaler usage recorded using a data logger device
To measure usage of inhaled reliever medication
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start4 Aug 2014
- Primary completion8 Aug 2016
- Study completion8 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Nicola Barker, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215341
- Sponsor's protocol ID
- SCH/14/011
- Acronym
- PhysDB
- Status last verified
- Dec 2019
- First submitted
- 23 Apr 2015
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Barker N, Thomas LA, Everard ML, Elphick HE. Breathing retraining for paediatric dysfunctional breathing with objective improvements in breathing patterns. Eur J Pediatr. 2026 Jul 30;185(8):627. doi: 10.1007/s00431-026-07292-9.
PubMed 42530674
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study for a Multi-centre Trial Investigating Whether Physiotherapy Improves Outcomes for Children With Dysfunctional Breathing
- ClinicalTrials.gov ID
- NCT04215341
- Acronym / sponsor ID
- PhysDB / SCH/14/011
- Conditions
- Dysfunctional Breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- 4 Aug 2014 (actual)
- Primary completion
- 8 Aug 2016 (actual)
- Study completion
- 8 Aug 2016 (actual)
- First posted
- 2 Jan 2020 (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.
Dysfunctional breathing in children primarily affects the ability to participate in sport or exercise but can also stop children doing other activities such as playing musical instruments. Clinical experience has shown that physiotherapy (through the use of breathing retraining and other associated techniques) can stop the symptoms of dysfunctional breathing, allowing children to return to normal activities and reduce or stop inhaled medications.
Whilst there is some evidence in adults with this condition to support the use of physiotherapy, there have been no studies carried out in children investigating whether physiotherapy is beneficial for children with dysfunctional breathing.
This study therefore aims to investigate the feasibility of a future large scale multicentre clinical trial designed to investigate whether physiotherapy improves outcomes for children with dysfunctional breathing. The improved management of this common but under recognised condition would lead to significant improvements in the quality of life of children coupled with the reduction in potentially harmful medications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: PhysiotherapyThe study contains a single arm. All children participating in the study will receive the primary intervention which is physiotherapy. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Aged 8-16 years Clinical diagnosis of dysfunctional breathing
Key exclusion criteria (1 listed)
- Uncontrolled comorbidities Participant and parents/guardians not fluent in written and spoken English Inability to follow instructions
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 |
|---|---|---|
| PhysiotherapyAlso: None - Inhalers and scans are not interventionsA course of breathing retraining delivered by a physiotherapist and practiced by the participant at home. | Behavioural | 1 |
Primary outcome
Child and parent proxy report versions of the quality of life questionnaire(PedsQL)
Time frame: 24 months
To measure participant and parent proxy report of quality of life in the four domains of physical, emotional, social and school functioning
3 secondary outcomes
Symptom questionnaire (Nijmegen questionnaire)
Time frame: 24 months
Structured light plethysmography (SLP) scan (Thora-3DI)
Time frame: 24 months
Reliever inhaler usage recorded using a data logger device
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Derived from this study: PubMed 42530674Barker N, Thomas LA, Everard ML, Elphick HE. Breathing retraining for paediatric dysfunctional breathing with objective improvements in breathing patterns. Eur J Pediatr. 2026 Jul 30;185(8):627. doi: 10.1007/s00431-026-07292-9.
Related trials for Dysfunctional Breathing
Not yet recruitingObservational study
Prevalence and Association of Dysfunctional Breathing With Nicotine Dependence and Physical Activity Among Young Smokers
Dysfunctional Breathing, Physical Activity
Not yet recruiting
Effort of Breathing and Dyssynchrony Burden During Assisted Ventilation in Paediatric Patients
Mechanical Ventilation, Paediatric Intensive Care
Recruiting
OptiMuscle - Improving Respiration by Optimising Muscle Function
Dysfunctional Breathing, Breathing Pattern Disorder
RecruitingObservational study
Smartphone Addiction, Posture and Breathing Control in University Students
Smartphone Addiction, Postural Disorders
RecruitingObservational study
Swiss Paediatric Airway Cohort
Asthma, Wheezing
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.
Nicola Barker principal investigator
Investigator
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, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 2 Jan 2020. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child and parent proxy report versions of the quality of life questionnaire(PedsQL) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04215341, which also lists 1 linked publication.
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 2 Jan 2020; AzTrials last refreshed its copy on 26 Oct 2026.