OptiMuscle - Improving Respiration by Optimising Muscle Function (OptiMuscle)

August 17, 2026 updated by: Stephen Preece, University of Salford

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M6 6PU
        • Recruiting
        • University of Salford
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Lung Function
Time Frame: Change from Baseline to 8 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Nijmegen Score
Time Frame: Change from Baseline to 8 weeks
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
Time Frame: Change from Baseline to 8 weeks
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)
Time Frame: Change from Baseline to 8 weeks
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)
Time Frame: Change from Baseline to 8 weeks
Used to measure anxiety. Score 0-21 (no = no anxieity, 21=maximum anxiety)
Change from Baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Salford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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