OptiMuscle - Improving Respiration by Optimising Muscle Function

Study Overview
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Brief Summary
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The primary aim will be to understand whether a digital breathing biofeedback system can improve the outcomes of physiotherapist guided breathing retraining.

Detailed Description
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Approximately 10% of people in the United Kindom exhibit some form of dysfunctional breathing. This term describes a range of conditions which are characterised by an impairment in the muscular control of breathing and which can result in breathlessness, hyperventilation and, in some cases, dizziness. Current clinical assessment techniques and treatments for dysfunctional breathing are low-tech. The investigators propose that patients would get more benefit from a system which uses biofeedback on muscle patterns to guide breathing re-education. The investigators have developed a new digital health system for the clinical management of dysfunctional breathing. The system uses an avatar to provide biofeedback to communicate abnormal muscle function in real-time, guiding patients through a process in which they gradually learn the correct muscular control of breathing. The proposed intervention seeks to understand if the addition of a digital breathing biofeedback system improves the outcomes of physiotherapy guided breathing retraining. Patients awaiting respiratory physiotherapy for dysfunctional breathing will be recruited to receive 4 sessions of breathing retraining with the assistance of the digital breathing biofeedback system. All patients will complete lung function tests and Quality of Life questionnaires pre- and post- treatment. Patients will also be offered an interview to understand their experiences of using the system.

Official Title
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Improving Outcomes in Dysfunctional Breathing Through the Optimization of Muscle Function (OptiMuscle)

Conditions
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Dysfunctional Breathing, Breathing Pattern Disorder

Intervention / Treatment
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* Behavioral: Digital Breathing Biofeedback system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to stand and walk independently History of breathing difficulties, such as breathlessness and difficult or laboured breathing for at least previous 6 months. Clinical diagnosis of dysfunctional breathing, sometimes referred to as breathing pattern disorder. If participants have co-existing respiratory problems, e.g. asthma, these should not be felt (in the opinion of the referring clinician) to be the cause of the current symptoms of breathlessness. Exclusion Criteria: Inability to speak and understand English sufficient to read and understand the information sheet and sign the consent form. BMI >34 Currently receiving active treatment for dysfunctional breathing Received treatment for acute lower respiratory tract infection or asthma exacerbation with last 4 weeks Significant respiratory co-morbidity (i.e. where the major respiratory diagnosis is not asthma)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The primary aim is to carry out preliminary testing of the intervention and to use feedback from participants to make small changes to the intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital Breathing Biofeedback system<br>Patients will receive 4 physiotherapist-guided breathing retraining sessions with the digital breathing biofeedback system. | Behavioral: Digital Breathing Biofeedback system<br>* The biofeedback system provides information to the patient and physio about the muscle coordination of breathing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lung Function | Spirometry test of lung volume will be measured included tidal volume and forced expiratory volumes. (Larger volumes = better lung function) | Change from Baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Nijmegen Score | Used to capture the extent of hyperventilation. Score 0-64 (0=no hyperventilation, 64=maximum hyperventilation) | Change from Baseline to 8 weeks | 
| Change in the Brief Illness Perception Questionnaire | Used ot evaluate cognitive and emotional representations of illness. Score 0-80 (0=no threatening perception of illness, 80=maximum threatening perception of illness) | Change from Baseline to 8 weeks | 
| Change in Patient Health Questionnaire (PHQ-9) | Used to measure depression.Score 0-28 (0=no depression, 28=maximum depression) | Change from Baseline to 8 weeks | 
| Change in the Generalised anxieity disorder (GAD-7) | Used to measure anxiety. Score 0-21 (no = no anxieity, 21=maximum anxiety) | Change from Baseline to 8 weeks |