NCT07543588

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

February 11, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

BreathlessnessBreathing Pattern DisorderPhysiotherapyAssessment

Outcome Measures

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.

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

Secondary Outcomes (7)

  • Nijmegen Questionnaire

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

  • Dyspnoea 12 (D-12) Questionnaire

    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)

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

  • Breath Hold

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

  • End Tidal C02

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

  • +2 more secondary outcomes

Study Arms (3)

Breathing Pattern Disorder

Patients referred to physiotherapy with a Breathing Pattern Disorder

Diagnostic Test: Assessment of Breathing Pattern- Breathing Pattern Assessment Tool

Healthy Control

Patients with no respiratory symptoms or disorders

Diagnostic Test: Assessment of Breathing Pattern- Breathing Pattern Assessment Tool

Asthma

Patients diagnosed with asthma but no concerns for breathing pattern disorder

Diagnostic Test: Assessment of Breathing Pattern- Breathing Pattern Assessment Tool

Interventions

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

AsthmaBreathing Pattern DisorderHealthy Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton Hospital

London, London, SW3 6NP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lizzie JF Grillo, BSc MSc

    Royal Brompton and Harefield Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lizzie Grillo JF Clinical Specialist Physiotherapist, BSc MSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Advanced Physiotherapist

Study Record Dates

First Submitted

February 11, 2026

First Posted

April 22, 2026

Study Start

December 10, 2024

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Start: 6 months after publication of primary results. End: Indefinitely
Access Criteria
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.

Locations