OptiMuscle - Improving Respiration by Optimising Muscle Function

Sponsor
University of Salford (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06103955
Collaborator
(none)
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Digital Breathing Biofeedback system
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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 interventionThe primary aim is to carry out preliminary testing of the intervention and to use feedback from participants to make small changes to the intervention
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Improving Outcomes in Dysfunctional Breathing Through the Optimization of Muscle Function (OptiMuscle)
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Lung Function [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)

Secondary Outcome Measures

  1. Change in Nijmegen Score [Change from Baseline to 8 weeks]

    Used to capture the extent of hyperventilation. Score 0-64 (0=no hyperventilation, 64=maximum hyperventilation)

  2. Change in the Brief Illness Perception Questionnaire [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)

  3. Change in Patient Health Questionnaire (PHQ-9) [Change from Baseline to 8 weeks]

    Used to measure depression.Score 0-28 (0=no depression, 28=maximum depression)

  4. Change in the Generalised anxieity disorder (GAD-7) [Change from Baseline to 8 weeks]

    Used to measure anxiety. Score 0-21 (no = no anxieity, 21=maximum anxiety)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Salford Manchester Greater Manchester United Kingdom M6 6PU

Sponsors and Collaborators

  • University of Salford

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Stephen Preece, Professor of Biomechanics and Rehabilitation, University of Salford
ClinicalTrials.gov Identifier:
NCT06103955
Other Study ID Numbers:
  • 2192
First Posted:
Oct 27, 2023
Last Update Posted:
Oct 27, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 27, 2023