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OptiMuscle - Improving Respiration by Optimising Muscle Function

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06103955
Acronym
OptiMuscle
Enrollment
10
Registered
2023-10-27
Start date
2024-03-01
Completion date
2027-06-30
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breathing Pattern Disorder, Dysfunctional Breathing

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.

Interventions

BEHAVIORALDigital Breathing Biofeedback system

The biofeedback system provides information to the patient and physio about the muscle coordination of breathing.

Sponsors

University of Salford
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Lung FunctionChange from Baseline to 8 weeksSpirometry test of lung volume will be measured included tidal volume and forced expiratory volumes. (Larger volumes = better lung function)

Secondary

MeasureTime frameDescription
Change in Nijmegen ScoreChange from Baseline to 8 weeksUsed to capture the extent of hyperventilation. Score 0-64 (0=no hyperventilation, 64=maximum hyperventilation)
Change in the Brief Illness Perception QuestionnaireChange from Baseline to 8 weeksUsed ot evaluate cognitive and emotional representations of illness. Score 0-80 (0=no threatening perception of illness, 80=maximum threatening perception of illness)
Change in Patient Health Questionnaire (PHQ-9)Change from Baseline to 8 weeksUsed to measure depression.Score 0-28 (0=no depression, 28=maximum depression)
Change in the Generalised anxieity disorder (GAD-7)Change from Baseline to 8 weeksUsed to measure anxiety. Score 0-21 (no = no anxieity, 21=maximum anxiety)

Countries

United Kingdom

Contacts

CONTACTStephen J Preece, PhD
s.preece@salford.ac.uk+44 161 295 2273
CONTACTAdam M Handley, MSc
a.m.handley@salford.ac.uk+44 161 295 6758

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026