AzTrials
AzTrials

Breathing Pattern DisorderPHABNCT07543588

The Physiotherapy Assessment of Breathing Pattern Disorder

An observational study of Breathing Pattern Disorder and Breathlessness, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study aims to evaluate a clinical tool called the Breathing Pattern Assessment Tool (BPAT), which is used by physiotherapists to assess breathing pattern disorder (BPD). BPD is a condition where breathing is inefficient or out of sync with the body's needs, leading to symptoms such as breathlessness. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Breathing Pattern Disorder, Breathlessness
What is being tested?
Assessment of Breathing Pattern- Breathing Pattern Assessment Tool
How many people
150 participants
Where
1 siteUnited Kingdom
Study dates
10 Dec 2024to 1 May 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients with BPD (n=100) A convenience sample of patients referred to physiotherapy outpatient services of Royal Brompton Hospitals for BPD or unexplained breathlessness, over a 22-month recruitment period will be recruited. Healthy control (n=25) A convenience sample of healthy controls will be recruited from relative/significant other accompanying the study participant and/or hospital staff. Asthma control patients (n=25) Patients will be recruited from the Systematic Assessment of Asthma Clinic and data used from their completed usual care assessment.

Who may be able to join

  • Adults aged above 18 years
  • Outpatient referrals for 'unexplained breathlessness' or possible breathing pattern disorder
  • Primary BPD (no other significant respiratory or cardiology diagnosis)
  • Secondary BPD (patients with a diagnosis of asthma)
  • Able to complete up to four sessions of outpatient physiotherapy intervention Exclusion Criteria
  • Patients with a respiratory diagnosis including COPD, ILD, Bronchiectasis and Cystic Fibrosis or structural heart disease
Show all 10Show fewer
  • Pregnancy
  • Unable to give informed consent
  • Anyone currently participating in pulmonary/cardiac rehabilitation
  • Anyone receiving specialist ENT speech and language therapy for Upper airway symptoms

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lizzie Grillo JF Clinical Specialist Physiotherapist, BSc MSc contact

07843203979

lizzie.grillo1@nhs.net

United Kingdom1 site, 1 recruiting
  • Royal Brompton Hospital

    London, London, SW3 6NP

    Lizzie JF Grillo, MSc, +447843203979, l.grillo@imperial.ac.uk

    Lizzie JF Grillo, MSc

    Recruiting

Other trials in United Kingdom

About this study

Official title: An Evaluation of Physiotherapy Assessment; A Mixed Methods Study to Evaluate the Physiotherapy Assessment of Breathing Pattern Disorder

This study aims to evaluate a clinical tool called the Breathing Pattern Assessment Tool (BPAT), which is used by physiotherapists to assess breathing pattern disorder (BPD). BPD is a condition where breathing is inefficient or out of sync with the body's needs, leading to symptoms such as breathlessness.

The study will investigate whether the BPAT is a reliable and accurate way to identify and assess BPD, and whether it can be used to monitor changes over time, particularly following physiotherapy treatment. It will also compare BPAT scores with other commonly used questionnaires that measure breathlessness and breathing symptoms.

Read more

Participants will include patients with BPD, patients with asthma, and healthy individuals. Patients with BPD will attend physiotherapy sessions as part of their usual care, during which their breathing will be assessed using the BPAT at different time points, including before and after treatment. Healthy participants will attend a single assessment visit, and asthma participants' data will be collected from routine clinical care.

The study will also explore whether BPAT scores change following treatment and whether these changes reflect improvements reported by patients and clinicians.

In addition, a small number of patients and physiotherapists will be invited to take part in interviews to share their experiences of the assessment process and treatment. This will help understand whether the BPAT is acceptable and useful in clinical practice.

Overall, this study aims to improve how breathing pattern disorder is assessed and monitored, which may help guide better treatment for patients in the future.

Read the detailed description

This study will evaluate the measurement properties and clinical usefulness of the Breathing Pattern Assessment Tool (BPAT), a physiotherapist-completed assessment used to identify breathing pattern disorder (BPD). BPD is a condition in which breathing is inefficient or inappropriate for the body's needs and is associated with symptoms such as breathlessness.

The study aims to determine whether the BPAT is a reliable and valid method for identifying and assessing BPD, and whether it can be used to monitor changes over time, particularly following physiotherapy treatment. BPAT scores will be compared with established questionnaires that measure breathing symptoms and breathlessness. The study will also assess whether changes in BPAT scores reflect changes reported by patients and clinicians.

Participants will include patients with BPD (n=100), patients with asthma (n=25), and healthy controls (n=25). Patients with BPD will be recruited from physiotherapy outpatient services and will receive physiotherapy as part of usual care. Healthy controls will attend a single assessment visit, and asthma control data will be obtained from routine clinical assessments.

At the initial assessment, two physiotherapists will independently complete BPAT scores for each participant. Patients with BPD will attend a follow-up assessment within approximately 4 weeks, where a repeat BPAT assessment will be completed. Those diagnosed with BPD will then undergo a course of physiotherapy treatment as part of usual care, typically consisting of four sessions. BPAT and other outcome measures will be repeated at the end of treatment (up to 6 months). Patients and clinicians will also provide ratings of change in symptoms following treatment.

The study will evaluate the reliability of the BPAT between clinicians and across time, its validity through comparison with other commonly used outcome measures, and its responsiveness to change following treatment.

In addition, a subgroup of patients and physiotherapists will take part in qualitative interviews to explore their experiences of the BPAT and its use in clinical practice. These interviews will help assess the acceptability and practicality of the tool.

This mixed-methods study aims to improve the assessment and monitoring of breathing pattern disorder and to support more consistent and effective clinical care.

Being tested
Assessment of Breathing Pattern- Breathing Pattern Assessment Tool
Keywords
Breathlessness, Breathing Pattern Disorder, Physiotherapy, Assessment
Medical subject headings
Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Assessment of Breathing Pattern- Breathing Pattern Assessment ToolDiagnostic test

    Patients who have Breathing Pattern Disorder will be assessed with the Breathing Pattern Assessment Tool and then will undergo Physiotherapy intervention. This includes up to 4 sessions of physiotherapy treatments which include biomechanical, biochemical and psychopathological interventions for breathing pattern

Study groups in NCT07543588
Study groupRoleWhat they receive
Breathing Pattern DisorderPatients referred to physiotherapy with a Breathing Pattern Disorder
Receives: Diagnostic Test: Assessment of Breathing Pattern- Breathing Pattern Assessment Tool
Healthy ControlPatients with no respiratory symptoms or disorders
Receives: Diagnostic Test: Assessment of Breathing Pattern- Breathing Pattern Assessment Tool
AsthmaPatients diagnosed with asthma but no concerns for breathing pattern disorder
Receives: Diagnostic Test: Assessment of Breathing Pattern- Breathing Pattern Assessment Tool

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Breathing Pattern Assessment Tool BPAT

    The Breathing Pattern Assessment Tool (BPAT) is a clinician-completed assessment of breathing pattern. Assessment components include (i) evaluation of chest/abdominal wall movement, noise of (ii) inspiratory and (iii) expiratory flow, (iv) channel of inspiration and expiration, (v) signs of air hunger (yawning, sighing and deeper breaths), (vi) RR and (vii) rhythm. Each component is scored from 0 (normal) to 2 (severely abnormal), with a total score ranging from 0 to 14. Higher scores indicate greater deviation from normal breathing patterns. Changes in score over time reflect changes in breathing pattern.

    Measured: Baseline for all participants; 4 weeks and through study completion (up to 6 months) for participants with Breathing Pattern Disorder

Secondary outcomes (7)
  1. Nijmegen Questionnaire

    The Nijmegen Questionnaire is a 16-item patient-reported outcome measure assessing symptoms associated with breathing pattern disorder and hyperventilation. Each item is scored from 0 ("never") to 4 ("very often"), with a total score ranging from 0 to 64. Higher scores indicate greater symptom severity. Scores of 19 or above are commonly considered indicative of clinically significant symptoms. Changes in score over time reflect changes in symptom severity.

    Measured: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder

  2. Dyspnoea 12 (D-12) Questionnaire

    The Dyspnoea-12 Questionnaire is a 12-item patient-reported outcome measure assessing the severity of breathlessness, including both physical and affective components. Each item is scored from 0 ("none") to 3 ("severe"), with a total score ranging from 0 to 36. Higher scores indicate worse breathlessness (greater dyspnoea severity). Changes in score over time reflect changes in symptom severity.

    Measured: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder

  3. EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)

    The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) is a standardized measure of health-related quality of life comprising a descriptive system and a visual analogue scale (EQ VAS). The descriptive system assesses five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on five levels from 1 ("no problems") to 5 ("extreme problems"), which can be converted into a single index score. The descriptive system responses are converted into a single index score using established value sets, typically ranging from less than 0 (worse than death) to 1 (full health). The EQ VAS records self-rated health on a scale from 0 ("worst imaginable health") to 100 ("best imaginable health"). Higher scores indicate better health-related quality of life, while lower scores indicate poorer health status.

    Measured: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder

  4. Breath Hold

    Breath-Hold Time (seconds) is a functional measure of respiratory control and tolerance to carbon dioxide. It is assessed as the duration, in seconds, that a participant can comfortably hold their breath following a normal exhalation. Typical values in healthy adults are approximately 20 to 40 seconds. Higher values indicate better respiratory control and greater tolerance to carbon dioxide, while lower values indicate poorer tolerance and potential breathing pattern disorder (hyperventilation). Changes in breath-hold time over time reflect changes in respiratory function. There is no fixed upper limit; values are recorded in seconds.

    Measured: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder

  5. End Tidal C02

    End-Tidal Carbon Dioxide (EtCO₂, mmHg) is an objective physiological measure of the partial pressure of carbon dioxide at the end of expiration, assessed using capnography via a nasal cannula. EtCO₂ is used as an indicator of ventilatory status. Lower values indicate relative hypocapnia and potential hyperventilation, while higher values within the normal physiological range indicate improved ventilatory regulation. Changes in EtCO₂ over time reflect changes in respiratory function. Normal values are typically approximately 35-45 mmHg or 4.7 to 6.0 kPa.

    Measured: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder

  6. Breathing Vigilance Questionnaire

    The Breathing Vigilance Questionnaire (Breathe-VQ) is a 6-item patient-reported measure assessing the degree of conscious monitoring and attentional focus on breathing. Each item is rated on a Likert scale, with total scores ranging from 6 to 30. Higher scores indicate greater breathing vigilance or hyper-awareness of breathing, which is associated with dysfunctional breathing patterns. Lower scores indicate less conscious monitoring of breathing. Changes in score over time reflect changes in breathing-related vigilance.

    Measured: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder

  7. Self evaluation of breathing questionnaire

    The Self-Evaluation of Breathing Questionnaire (SEBQ) is a patient-reported outcome measure assessing symptoms associated with dysfunctional breathing. It consists of 25 items, each scored on a Likert scale, with a total score ranging from 0 to 75. Higher scores indicate worse breathing pattern disorder/dysfunctional breathing. A total score greater than 11 has been suggested as indicative of possible dysfunctional breathing. Changes in score over time reflect changes in symptom severity.

    Measured: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2026
  2. Study start10 Dec 2024
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07543588
Sponsor's protocol ID
315897
Acronym
PHAB
Status last verified
Apr 2026
First submitted
11 Feb 2026
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the results reported in publications, including baseline characteristics, outcome measures, and relevant covariates. All direct identifiers will be removed prior to sharing. Data will be made available for the IPD that underlie results in a publication. This will be available within the publication and anonymous data available on online repository

Questions about this trial

What is this clinical trial studying?

An observational study of Breathing Pattern Disorder and Breathlessness, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lizzie Grillo JF Clinical Specialist Physiotherapist, BSc MSc (07843203979, lizzie.grillo1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breathing Pattern Assessment Tool BPAT (time frame: Baseline for all participants; 4 weeks and through study completion (up to 6 months) for participants with Breathing Pattern Disorder). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in