Breathlessness Perceptions Within Respiratory Diseases
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis), Interstitial Lung Disease (ILD), Bronchiectasis. Basic parameters: 18 years — 100 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 →
Unsure about the terms? Read our patient guide →
Official title
Exploring Differences in Breathlessness Perceptions Within Respiratory Diseases
Overview
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.
Detailed description
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.
Primary outcome measures
- Breathing pattern regional contribution parameters [Time frame: From June 2025 to July 2026]
Secondary outcome measures (12)
- Breathing pattern-Timing parameters-Recording duration [Time frame: From June 2025 to July 2026]
- Breathing pattern-Timing parameters- Sampling frequency rate [Time frame: From June 2025 to July 2026]
- Breathing pattern-Timing Parameters- Number of respiratory cycles analysed [Time frame: From June 2025 to July 2026]
- Breathing pattern-Ratio parameters-Compartmental contributions [Time frame: From June 2025 to July 2026]
- Breathing pattern- Phase angle parameters [Time frame: From June 2025 to July 2026]
- Breathing pattern-ratio parameters- Temporal ratios [Time frame: From June 2025 to July 2026]
- Rate of Perceived Exertion (RPE) and Borg breathlessness scale [Time frame: From June 2025 to July 2026]
- Spirometry [Time frame: From June 2025 to July 2026]
- Modified Medical Research Council Dyspnea Scale (mMRC) [Time frame: From June 2025 to July 2026]
- Dysponea-12 (D-12) [Time frame: From June 2025 to July 2026]
- Hospital Anxiety and Depression Scale (HADS) [Time frame: From June 2025 to July 2026]
- Breathlessness catastrophising scale (BCS) [Time frame: From June 2025 to July 2026]
Eligibility criteria
Inclusion criteria
- • 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.
Exclusion criteria
- • 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
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
- Cohort
Study locations
United Kingdom · 1 center
- Glenfield Hospital — Leicester
Publications
- 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
Identifiers
NCT: NCT07648082 · 172675 · NIHR203327