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CompletedNCT04215341PhysDBUpdated Jan 2, 2020

Physiotherapy for Children With Dysfunctional Breathing

An interventional study of Physiotherapy in Dysfunctional Breathing, sponsored by Sheffield Children's NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 8 Years to 16 Years. Per ClinicalTrials.gov, last updated 2020-01-02.

Sponsored by Sheffield Children's NHS Foundation Trust · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Aug 2014, registered Apr 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
8 Years to 16 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Dysfunctional Breathing
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's enrollment of 31 is below the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Sheffield Children's NHS Foundation Trust is the lead sponsor of 51 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Aged 8-16 years Clinical diagnosis of dysfunctional breathing

Exclusion criteria

Exclusion Criteria:

Uncontrolled comorbidities Participant and parents/guardians not fluent in written and spoken English Inability to follow instructions

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    1

    The study contains a single arm. All children participating in the study will receive the primary intervention which is physiotherapy.

    Behavioral: Physiotherapy

Interventions

  • BehavioralPhysiotherapy

    A course of breathing retraining delivered by a physiotherapist and practiced by the participant at home.

    Also known as: None - Inhalers and scans are not interventions

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 months

Secondary outcomes

  1. Symptom questionnaire (Nijmegen questionnaire)

    To measure the type and frequency of symptoms commonly associated with dysfunctional breathing

    Time frame: 24 months

  2. Structured light plethysmography (SLP) scan (Thora-3DI)

    To objectively measure breathing pattern and rate without influencing these parameters

    Time frame: 24 months

  3. Reliever inhaler usage recorded using a data logger device

    To measure usage of inhaled reliever medication

    Time frame: 24 months

07

Study locations

1 site
  • Sheffield Children's NHS Foundation Trust
    Sheffield, Sheffield (South Yorkshire District) S10 2TH, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04215341
Lead sponsor
Sheffield Children's NHS Foundation Trust
Collaborators
University of Sheffield
Responsible party
Sponsor
First posted
Jan 2, 2020
Start date
Aug 4, 2014
Primary completion
Aug 8, 2016
Completion
Aug 8, 2016
Last update
Jan 2, 2020

Study contacts

Nicola Barker
principal investigator · Investigator

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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