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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04215341
Other study ID # SCH/14/011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 4, 2014
Est. completion date August 8, 2016

Study information

Verified date December 2019
Source Sheffield Children's NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date August 8, 2016
Est. primary completion date August 8, 2016
Accepts healthy volunteers No
Gender All
Age group 8 Years to 16 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United Kingdom Sheffield Children's NHS Foundation Trust Sheffield Sheffield (South Yorkshire District)

Sponsors (2)

Lead Sponsor Collaborator
Sheffield Children's NHS Foundation Trust University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

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