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Recruiting NCT07543588

The Physiotherapy Assessment of Breathing Pattern Disorder

Observational Breathing Pattern Disorder Breathlessness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Assessment of Breathing Pattern- Breathing Pattern Assessment Tool.
Who it may be relevant to
Registry conditions: Breathing Pattern Disorder, Breathlessness. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Diagnostic test Assessment of Breathing Pattern- Breathing Pattern Assessment Tool
    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

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • Nijmegen Questionnaire [Time frame: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder]
  • Dyspnoea 12 (D-12) Questionnaire [Time frame: 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) [Time frame: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder]
  • Breath Hold [Time frame: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder]
  • End Tidal C02 [Time frame: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder]
  • Breathing Vigilance Questionnaire [Time frame: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder]
  • Self evaluation of breathing questionnaire [Time frame: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder]

Eligibility criteria

Inclusion Criteria (Breathing Pattern Disorder group)

  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United Kingdom · 1 center
  • Royal Brompton Hospital — London

Identifiers

NCT: NCT07543588 · 315897

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗