Breathlessness Perceptions Within Respiratory Diseases
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Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis), Interstitial Lung Disease (ILD), Bronchiectasis. Базовые параметры: 18 лет — 100 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
Exploring Differences in Breathlessness Perceptions Within Respiratory Diseases
Обзор
Breathlessness is a complex symptom that results in poor quality of life, increased hospitalisations and increased mortality. Breathlessness is influenced by physiological, psychological and functional factors but these are poorly explored. There are also unexplored phenomenon's such as breathing pattern. Therefore, this study aims to understand the influences of physiology, psychology, function and breathing pattern on health related quality of life in those with a respiratory disease compared to healthy controls. This project is a cross-sectional cohort study including those with a known respiratory disease and experiencing breathlessness, compared to non-breathless healthy controls. The investigators will measure your physiology through spirometry (a breathing test that tells us about their lung function), psychology through questionnaires, function through an exercise test and breathing pattern using opto-electrictronic plethysmography (markers are placed on your chest to see how participants breathe while exercising). This will be conducted over two visits. The investigators will recruit participants from clinics at the University Hospitals of Leicester NHS Trust. The investigators are aiming to recruit 50 participants with a respiratory disease and 25 healthy controls. The results of this study will help us understand breathlessness in more detail in order to be able to develop better treatments.
Подробное описание
Breathlessness is a debilitating symptom that results in poorer quality of life, increased hospitalisations, and increased mortality. Breathlessness is a complex multi-dimensional sensation with established bio-psycho-social influences (Hayen et al., 2013) that are likely to interact, though the mechanisms or relative contributions of these interactions are unknown (Oxley \& Macnaughton, 2016). Breathlessness is a hallmark feature of respiratory disease and is the primary reason for seeking healthcare advice and treatments. Though currently breathlessness management follows a one-size fits all approach and does not pay consideration to the unique and individual experience of breathlessness.
The breathing thinking functioning (BTF) model of breathlessness is a theoretical framework that attempts to explain this complex and multifactorial symptom, however it lacks scientific premise. Highlighting that physiology, psychology and function will all play a role in determining breathlessness for the individual. An additional complication, that is seldom explored is disordered breathing patterns. This is potentially bi-directional where by severe breathlessness could contribute to disordered breathing and/or disordered breathing could lead to severe breathlessness. There is currently no objective marker of disordered breathing pattern however, use of optoelectronic plethysmography (OEP) has shown promise in quantifying this phenomenon (Smyth, 2021). OEP is a novel technique, utilising 3-dimensional motion capture, and can be measured during exercise, using a cardiopulmonary exercise testing, which allows for monitoring of breathlessness and breathing pattern during exercise, commonly reported as troublesome by patients. OEP has been used in Chronic Obstructive Pulmonary Disease to assess hyperinflation, though evidence within respiratory disease is at its infancy, and has not been explored alongside other factors to understand the contribution of multiple factors of breathlessness. Therefore, there is a current gap in the literature exploring the interaction(s) of factors contributing to breathlessness severity, including the objective analysis of breathing pattern. Further understanding the breathlessness in this way could lead to personalisation or treatments increasing their effectiveness, and improving health and quality of life. The project will quantitatively measure breathlessness perception, alongside objective cardiorespiratory measures and background health and well-being data as well as OEP breathing pattern data (such as compartment contribution and inter-compartment asynchrony). This will allow an understanding of how each of these factors may affect interventions and differences in breathlessness experience and presentation, and subsequently the acceptability of breathlessness.
Первичные конечные точки
- Breathing pattern regional contribution parameters [Срок оценки: From June 2025 to July 2026]
Вторичные конечные точки (12)
- Breathing pattern-Timing parameters-Recording duration [Срок оценки: From June 2025 to July 2026]
- Breathing pattern-Timing parameters- Sampling frequency rate [Срок оценки: From June 2025 to July 2026]
- Breathing pattern-Timing Parameters- Number of respiratory cycles analysed [Срок оценки: From June 2025 to July 2026]
- Breathing pattern-Ratio parameters-Compartmental contributions [Срок оценки: From June 2025 to July 2026]
- Breathing pattern- Phase angle parameters [Срок оценки: From June 2025 to July 2026]
- Breathing pattern-ratio parameters- Temporal ratios [Срок оценки: From June 2025 to July 2026]
- Rate of Perceived Exertion (RPE) and Borg breathlessness scale [Срок оценки: From June 2025 to July 2026]
- Spirometry [Срок оценки: From June 2025 to July 2026]
- Modified Medical Research Council Dyspnea Scale (mMRC) [Срок оценки: From June 2025 to July 2026]
- Dysponea-12 (D-12) [Срок оценки: From June 2025 to July 2026]
- Hospital Anxiety and Depression Scale (HADS) [Срок оценки: From June 2025 to July 2026]
- Breathlessness catastrophising scale (BCS) [Срок оценки: From June 2025 to July 2026]
Критерии участия
Критерии включения
- • Aged 18 or over up to 100
- Known respiratory diagnosis\* OR Healthy control\*\*
- Ongoing symptoms of breathlessness defined as ≥2 MRC dyspnoea scale
- Able to communicate in English
- Able to attend two study visits
- Able to provide written informed consent
- Known respiratory diagnosis could include, but is not limited to, COPD, Asthma, Bronchiectasis or ILD.
- Healthy controls are required to have an absence of a functionally limiting condition such as respiratory, cardiovascular, or musculoskeletal.
Критерии исключения
- • Unstable disease or undergoing investigations for unexplained symptoms
- Undergone a surgery within past six weeks
- Contraindications for exercise outlined by ACSM guidelines (Unstable CVD, hypertension etc)
- BMI ≥ 35kg/m2
- Unable to communicate in English
- Unable to provide written informed consent
- Unable to abstain from smoking for 8 hours prior to testing
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Великобритания · 1 центр
- Glenfield Hospital — Leicester
Публикации
- Pritchard A, Burns P, Correia J, Jamieson P, Moxon P, Purvis J, Thomas M, Tighe H, Sylvester KP. ARTP statement on cardiopulmonary exercise testing 2021. BMJ Open Respir Res. 2021 Nov;8(1):e001121. doi: 10.1136/bmjresp-2021-001121. PMID 34782330
- Oxley R, Macnaughton J. Inspiring change: humanities and social science insights into the experience and management of breathlessness. Curr Opin Support Palliat Care. 2016 Sep;10(3):256-61. doi: 10.1097/SPC.0000000000000221. PMID 27490147
- Hayen A, Herigstad M, Pattinson KT. Understanding dyspnea as a complex individual experience. Maturitas. 2013 Sep;76(1):45-50. doi: 10.1016/j.maturitas.2013.06.005. Epub 2013 Jul 10. PMID 23849705
Идентификаторы
NCT: NCT07648082 · 172675 · NIHR203327