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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breathing Pattern Disorder | Patients referred to physiotherapy with a Breathing Pattern Disorder |
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| Healthy Control | Patients with no respiratory symptoms or disorders |
| |
| Asthma | Patients diagnosed with asthma but no concerns for breathing pattern disorder |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessment of Breathing Pattern- Breathing Pattern Assessment Tool | Diagnostic 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline for all participants; 4 weeks and through study completion (up to 6 months) for participants with Breathing Pattern Disorder |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria (Breathing Pattern Disorder group)
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lizzie Grillo JF Clinical Specialist Physiotherapist, BSc MSc | Contact | 07843203979 | lizzie.grillo1@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Lizzie JF Grillo, BSc MSc | Royal Brompton and Harefield Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brompton Hospital | Recruiting | London | London | SW3 6NP | United Kingdom |
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
Start: 6 months after publication of primary results. End: Indefinitely
Qualified researchers may request access to de-identified individual participant data. Requests will be reviewed by the study investigators. Approved data will be shared via a secure online repository or by direct data transfer. Data will be limited to de-identified datasets necessary to reproduce the reported analyses.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 17, 2023 | Apr 22, 2026 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: Stage 1 Consent Form | May 15, 2023 | Apr 22, 2026 | ICF_004.pdf |
| ICF | No | No | Yes | Informed Consent Form: Stage 2 consent form | May 17, 2023 | Apr 22, 2026 | ICF_005.pdf |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder |
| 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. | Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder |
| 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. | Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder |
| 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. | Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder |
| 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. | Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder |
| 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. | Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder |
| 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. | Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder |
| D013568 | Pathological Conditions, Signs and Symptoms |