OptiMuscle - Improving Respiration by Optimising Muscle Function
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Salford
About this trial
The primary aim will be to understand whether a digital breathing biofeedback system can improve the outcomes of physiotherapist guided breathing retraining.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Digital Breathing Biofeedback system
BehavioralThe biofeedback system provides information to the patient and physio about the muscle coordination of breathing.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Digital Breathing Biofeedback systemExperimental treatment 1 intervention
Trial outcomes
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)
Time frame
Change from Baseline to 8 weeksSecondary outcomes
1
Change in Nijmegen Score
Used to capture the extent of hyperventilation. Score 0-64 (0=no hyperventilation, 64=maximum hyperventilation)
Time frame
Change from Baseline to 8 weeks2
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)
Time frame
Change from Baseline to 8 weeks3
Change in Patient Health Questionnaire (PHQ-9)
Used to measure depression.Score 0-28 (0=no depression, 28=maximum depression)
Time frame
Change from Baseline to 8 weeks4
Change in the Generalised anxieity disorder (GAD-7)
Used to measure anxiety. Score 0-21 (no = no anxieity, 21=maximum anxiety)
Time frame
Change from Baseline to 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov