OptiMuscle - Improving Respiration by Optimising Muscle Function

NCT06103955 | Recruiting

• 1 other identifier: 2192
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dysfunctional Breathing; Breathing Pattern Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Nijmegen Score

  Change from Baseline to 8 weeks

• Change in the Brief Illness Perception Questionnaire

  Change from Baseline to 8 weeks

• Change in Patient Health Questionnaire (PHQ-9)

  Change from Baseline to 8 weeks

• Change in the Generalised anxieity disorder (GAD-7)

  Change from Baseline to 8 weeks

Study Arms (1)

Digital Breathing Biofeedback system

EXPERIMENTAL

Patients will receive 4 physiotherapist-guided breathing retraining sessions with the digital breathing biofeedback system.

Behavioral: Digital Breathing Biofeedback system

Interventions

Digital Breathing Biofeedback system BEHAVIORAL

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

Digital Breathing Biofeedback system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Salford: lead

Study Sites (1)

University of Salford

Manchester, Greater Manchester, M6 6PU, United Kingdom

RECRUITING

Related Links

• Related Info

Central Study Contacts

Stephen J Preece, PhD

CONTACT

+44 161 295 2273; s.preece@salford.ac.uk

Adam M Handley, MSc

CONTACT

+44 161 295 6758; a.m.handley@salford.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biomechanics and Rehabilitation

Model Details: 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

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 27, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

GB (1)