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Идёт набор NCT07543588

The Physiotherapy Assessment of Breathing Pattern Disorder

Наблюдательное Breathing Pattern Disorder Breathlessness

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Assessment of Breathing Pattern- Breathing Pattern Assessment Tool.
Кому может быть актуально
Состояния в реестре: Breathing Pattern Disorder, Breathlessness. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест 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

Первичные конечные точки

  • Breathing Pattern Assessment Tool BPAT [Срок оценки: Baseline for all participants; 4 weeks and through study completion (up to 6 months) for participants with Breathing Pattern Disorder]
Вторичные конечные точки (7)
  • Nijmegen Questionnaire [Срок оценки: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder]
  • Dyspnoea 12 (D-12) Questionnaire [Срок оценки: 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) [Срок оценки: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder]
  • Breath Hold [Срок оценки: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder]
  • End Tidal C02 [Срок оценки: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder]
  • Breathing Vigilance Questionnaire [Срок оценки: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder]
  • Self evaluation of breathing questionnaire [Срок оценки: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Великобритания · 1 центр
  • Royal Brompton Hospital — London

Идентификаторы

NCT: NCT07543588 · 315897

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗