OptiMuscle - Improving Respiration by Optimising Muscle Function (OptiMuscle)

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

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

Study Overview

• Status: Recruiting
• Conditions: Dysfunctional Breathing; Breathing Pattern Disorder
• Intervention / Treatment: Behavioral: Digital Breathing Biofeedback system

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephen J Preece, PhD; Phone Number: +44 161 295 2273; Email: s.preece@salford.ac.uk
• Study Contact Backup: Name: Adam M Handley, MSc; Phone Number: +44 161 295 6758; Email: a.m.handley@salford.ac.uk

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M6 6PU
      • Recruiting
      • University of Salford
      • Contact: Stephen J Preece, PhD; Phone Number: +441612952273; Email: s.preece@salford.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Salford

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 2192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The investigators may make the clinical data available through a document which will be linked to the final published journal paper

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No