Physiotherapy for Children With Dysfunctional Breathing (PhysDB)

December 31, 2019 updated by: Sheffield Children's NHS Foundation Trust

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
The study contains a single arm. All children participating in the study will receive the primary intervention which is physiotherapy.
Behavioral: Physiotherapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom questionnaire (Nijmegen questionnaire)
Time Frame: 24 months
To measure the type and frequency of symptoms commonly associated with dysfunctional breathing
24 months
Structured light plethysmography (SLP) scan (Thora-3DI)
Time Frame: 24 months
To objectively measure breathing pattern and rate without influencing these parameters
24 months
Reliever inhaler usage recorded using a data logger device
Time Frame: 24 months
To measure usage of inhaled reliever medication
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Children's NHS Foundation Trust

Collaborators

University of Sheffield

Investigators

  • Principal Investigator: Nicola Barker, Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2014

Primary Completion (Actual)

August 8, 2016

Study Completion (Actual)

August 8, 2016

Study Registration Dates

First Submitted

April 23, 2015

First Submitted That Met QC Criteria

December 31, 2019

First Posted (Actual)

January 2, 2020

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 31, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCH/14/011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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