OptiMuscle - Improving Respiration by Optimising Muscle Function

Dysfunctional Breathing Clinical Trial

— OptiMuscle  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06103955
• Other study ID #: 2192
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: November 2023
• Source: University of Salford
• Contact: Stephen J Preece, PhD
• Phone: +44 161 295 2273
• Email: s.preece[@]salford.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dysfunctional Breathing
• Respiratory Aspiration

Intervention

Behavioral:
• Digital Breathing Biofeedback system
The biofeedback system provides information to the patient and physio about the muscle coordination of breathing.

Locations

Country	Name	City	State
United Kingdom	University of Salford	Manchester	Greater Manchester

Sponsors (1)

Lead Sponsor	Collaborator
University of Salford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

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