Clinical trial NCT06103955: OptiMuscle - Improving Respiration by Optimising Muscle Function
Official title: Improving Outcomes in Dysfunctional Breathing Through the Optimization of Muscle Function (OptiMuscle)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysfunctional Breathing
Breathing Pattern Disorder
Lead sponsor: University of Salford
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Lung Function
timeFrame: Change from Baseline to 8 weeks
Secondary outcomes:
measure: Change in Nijmegen Score
timeFrame: Change from Baseline to 8 weeks
measure: Change in the Brief Illness Perception Questionnaire
timeFrame: Change from Baseline to 8 weeks
measure: Change in Patient Health Questionnaire (PHQ-9)
timeFrame: Change from Baseline to 8 weeks
measure: Change in the Generalised anxieity disorder (GAD-7)
timeFrame: Change from Baseline to 8 weeks
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: University of Salford
state: Greater Manchester
Study officials:
References: