Physiotherapy for Children With Dysfunctional Breathing

NCT04215341 | Completed

• 1 other identifier: SCH/14/011
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysfunctional Breathing

Outcome Measures

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

  24 months

Secondary Outcomes (3)

• Symptom questionnaire (Nijmegen questionnaire)

  24 months

• Structured light plethysmography (SLP) scan (Thora-3DI)

  24 months

• Reliever inhaler usage recorded using a data logger device

  24 months

Study Arms (1)

1

EXPERIMENTAL

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

Behavioral: Physiotherapy

Interventions

Physiotherapy BEHAVIORAL

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

1

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 8-16 years Clinical diagnosis of dysfunctional breathing

You may not qualify if:

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

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead
• University of Sheffield: collaborator

Study Sites (1)

Sheffield Children's NHS Foundation Trust

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

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Nicola Barker

  Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: January 2, 2020
• Study Start: August 4, 2014
• Primary Completion: August 8, 2016
• Study Completion: August 8, 2016
• Last Updated: January 2, 2020

Record last verified: 2019-12

Locations

GB (1)