The Physiotherapy Assessment of Breathing Pattern Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal Brompton & Harefield NHS Foundation Trust
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Patients with a respiratory diagnosis including COPD, ILD, Bronchiectasis and Cystic Fibrosis or structural heart disease
Pregnancy
Unable to give informed consent
Anyone currently participating in pulmonary/cardiac rehabilitation
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Assessment of Breathing Pattern- Breathing Pattern Assessment Tool
Diagnostic testPatients 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
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Breathing Pattern Disorder1 intervention
Group B: Healthy Control1 intervention
Group C: Asthma1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Baseline for all participants; 4 weeks and through study completion (up to 6 months) for participants with Breathing Pattern DisorderSecondary outcomes
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.
Time frame
Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder2
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.
Time frame
Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder3
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.
Time frame
Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder4
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.
Time frame
Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern DisorderSponsors and contacts
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Source ClinicalTrials.gov