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Physiotherapy for Children With Dysfunctional Breathing (PhysDB)

Primary Purpose

Dysfunctional Breathing

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
Sheffield Children's NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dysfunctional Breathing

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sheffield Children's NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 23, 2015
Last Updated
December 31, 2019
Sponsor
Sheffield Children's NHS Foundation Trust
Collaborators
University of Sheffield
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1. Study Identification

Unique Protocol Identification Number
NCT04215341
Brief Title
Physiotherapy for Children With Dysfunctional Breathing
Acronym
PhysDB
Official Title
Feasibility Study for a Multi-centre Trial Investigating Whether Physiotherapy Improves Outcomes for Children With Dysfunctional Breathing
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 4, 2014 (Actual)
Primary Completion Date
August 8, 2016 (Actual)
Study Completion Date
August 8, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Children's NHS Foundation Trust
Collaborators
University of Sheffield

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysfunctional Breathing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
The study contains a single arm. All children participating in the study will receive the primary intervention which is physiotherapy.
Intervention Type
Behavioral
Intervention Name(s)
Physiotherapy
Other Intervention Name(s)
None - Inhalers and scans are not interventions
Intervention Description
A course of breathing retraining delivered by a physiotherapist and practiced by the participant at home.
Primary Outcome Measure Information:
Title
Child and parent proxy report versions of the quality of life questionnaire(PedsQL)
Description
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 Outcome Measure Information:
Title
Symptom questionnaire (Nijmegen questionnaire)
Description
To measure the type and frequency of symptoms commonly associated with dysfunctional breathing
Time Frame
24 months
Title
Structured light plethysmography (SLP) scan (Thora-3DI)
Description
To objectively measure breathing pattern and rate without influencing these parameters
Time Frame
24 months
Title
Reliever inhaler usage recorded using a data logger device
Description
To measure usage of inhaled reliever medication
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola Barker
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Children's NHS Foundation Trust
City
Sheffield
State/Province
Sheffield (South Yorkshire District)
ZIP/Postal Code
S10 2TH
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Physiotherapy for Children With Dysfunctional Breathing

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