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Completed

NCT Number: NCT04215341

Physiotherapy 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.

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Key information

Conditions

Dysfunctional Breathing

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheffield Children's NHS Foundation Trust

Sheffield, Sheffield (South Yorkshire District), S10 2TH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aged 8-16 years Clinical diagnosis of dysfunctional breathing

Exclusion criteria

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

Treatment and study plan

Physiotherapy

Behavioral

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

Other names: None - Inhalers and scans are not interventions

Primary outcomes

  1. 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

Secondary outcomes

  1. Symptom questionnaire (Nijmegen questionnaire)

    Time frame: 24 months

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

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

    Time frame: 24 months

    To objectively measure breathing pattern and rate without influencing these parameters

  3. Reliever inhaler usage recorded using a data logger device

    Time frame: 24 months

    To measure usage of inhaled reliever medication

Sponsors and collaborators

Lead sponsor

Sheffield Children's NHS Foundation Trust

Other

Collaborators

  • University of Sheffield

Registry information

Official study title

Feasibility Study for a Multi-centre Trial Investigating Whether Physiotherapy Improves Outcomes for Children With Dysfunctional Breathing

Acronym: PhysDB

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 2, 2020
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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