Dysfunctional Breathing: Characterisation and Assessment

NCT03043469 | Unknown

• 1 other identifier: 1468-NHS-Dec/2016- 4775-1
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

Dysfunctional breathing (DB) is a respiratory condition characterised by an abnormal breathing pattern, among other complaints, that can occur either in the absence of other pathophysiology (primary DB), e.g. anxiety-related factors, or secondary to cardiopulmonary disease (secondary DB), e.g. asthma. As a consequence, patients may experience breathlessness and present with periods of increased ventilation or erratic breathing, interspersed with episodes of breath holding or deep sighs. In addition to respiratory symptoms, DB also generates non- respiratory symptoms (e.g. dizziness and increased heart rate). It is estimated 1 in 10 people in the United Kingdom (UK) have DB. However, DB remains poorly understood, with no standardised approach to diagnosis and assessment. The purposes of this study are: Study 1) To identify physiological, functional and psychological characteristics of participants with DB compared to healthy participants. Firstly, symptoms, lung function, respiratory gas analysis, exercise capacity, respiratory muscle function, respiratory motion, level of physical activity, quality of life and anxiety \& depression scores will be assessed in 20 participants with primary DB, 20 with secondary DB and compared to 20 healthy participants. Study 2) To develop an assessment tool based on physiological, functional or psychological variables found to be different between any of the 3 groups in Study 1. In order to do that, 54 people with DB (between primary and secondary) and 27 people presenting with breathlessness secondary to restrictive lung disease will be assessed. Analysis of these data will determine whether these variables can be used as a diagnostic tool capable of distinguishing DB from restrictive lung diseases characterised by breathlessness. The recruitment period will be 1-2 years, with an individual participation of 9 days; 1-day on site testing, plus 7-day home activity monitoring, and 1 day to return the activity monitor (which will happen whenever the participant needs to return to the site).

Conditions

Respiration Disorder; Hyperventilation Syndrome; Breathlessness; Breath Shortness

Keywords

dysfunctional breathing

Outcome Measures

Primary Outcomes (5)

• Signs of Anxiety and Depression

  Anxiety and depression will be evaluated by the widely used Hospital Anxiety and Depression Scale (HADS), developed by Zigmond and Snaith (1983) to identify and screen cases of anxiety and depression in non-psychiatric environments. It has been proven to be a valid psychological instrument (Bjelland et al. 2002). The HADS is subdivided into two subscales with seven questions each: Anxiety (HADS-A) and Depression (HADS-B). Therefore, it is able to differentiate anxiety from depression possible/probable disorders.

  This scale will be applied only once during the first day of assessment and takes about 5 minutes for the participant to complete.

• Levels of subjective sensation related to Hyperventilation Syndrome

  The Nijmegen Questionnaire is a clinically used tool for analysis of 16 symptoms related to Hyperventilation syndrome arising from different body systems (such as chest pain, blurred vision and faster or deeper breathing). The participant will choose the answer from a 5-point ordinal scale considering the frequency of symptoms. 23 of 64 points or more is considered positive for abnormality of subjective sensations (van Dixhoorn and Folgering 2015) and correlates positively with Dysfunctional Breathing (Vansteenkiste, Rochette, Demedt, 1991).

  This scale will be applied only once and takes about 5 minutes to be completed by the participant.

• Self-evaluation of breathing

  The Self Evaluation Breathing Questionnaire is a reliable tool developed by Courtney and Greenwood (2009) to assess breathing pattern of participants with Dysfunctional Breathing (Mitchell et al. 2015). It contains 17 items that are answered using a 4-point Likert scale and includes two main factors: "lack of air", which is about feeling and sensing; and "perception of inappropriate or restricted breathing", which is about observing or noticing. It has been indicated that the higher the SEBQ score, the more severe is the clinical condition of Dysfunctional Breathing (Mitchell et al. 2015). However, researchers who created the SEBQ questionnaire suggested that it can be used as a screening tool for identifying Dysfunctional Breathing and for monitoring changes in breathing symptoms after treatment, but there is no normal value available in the literature for this questionnaire yet (Courtney, Greenwood, et al. 2011).

  This scale will be applied only once and takes about 5 minutes to be completed by the participant..

• Respiratory Motion

  The Manual Assessment of Respiratory Motion (MARM) will be used to assess thoracic and diaphragmatic movements during breathing and quantify their contribution as a percentage of the total breathing movement. During this evaluation, the examiner will position their open hands between posterior and lateral lower rib cage (lower four to six ribs) and the thumbs will vertically be positioned about 1 inch from the spine. In this position, it is possible for the examiner to identify lateral and vertical movements during breathing, as well as upper or lower rib cage predominance. The examiner will draw an upper, lower and horizontal lines starting from the centre of a circle, building a pie chart with the degree of expansion (Courtney et al. 2008, Courtney and van Dixhoorn 2014). A perfect balance between thoracic and abdominal motion during breathing presents a MARM between 0 and 6; as well as a value above 30 may be considered as dysfunctional (Courtney et al. 2011; Courtney et al. 2008).

  This assessment will be applied only once and takes about 10 minutes to be completed.

• Breath-holding time

  In the Breath-hold test, the variable considered is the total time the participant is able to hold a breath after a normal exhalation at functional residual capacity. This standardized protocol used in participants with DB is called the Buteyko Method of the Control Pause, where the breath is held and timed until the first involuntary motion of the respiratory muscles (Courtney and Cohen 2008). The breath-holding time has been estimated to be approximately 20 seconds patients with DB, while in healthy people is approximately 60 seconds (Jack et al. 2004, Courtney and Cohen 2008). Three attempts will be undertaken with 5-minute rest in between; a stopwatch will be used to time each one, as well as the intervals. The mean of the three attempts will be analysed, in order to remove any learnt effect (Courtney, Greenwood, et al. 2011).

  This assessment will be applied only once and takes about 20 minutes to be completed.

Secondary Outcomes (25)

• Medical History

  This assessment will be applied during the 3-hour assessment, and takes about 5 minutes to be completed.

• Age

  This assessment will be applied during the 3-hour assessment, and takes about 20 seconds to be completed.

• Gender

  This assessment will be applied during the 3-hour assessment, and takes about 10 seconds to be completed.

• Weight

  This assessment will be applied during the 3-hour assessment, and takes about 10 seconds to be completed.

• Height

  This assessment will be applied during the 3-hour assessment, and takes about 10 seconds to be completed.

Study Arms (4)

Healthy participants

Day 1: Hospital assessments (\~3 hours): Demographic data, Manual Assessment of Respiratory Motion, Slow-breathing task, Six-minute exercise test, Indirect calorimetry, Oxygen saturation monitoring, heart rate variability analysis, continuous measurement of arterial blood pressure, lung function test, the Nijmegen Questionnaire and the Self-Evaluation of Breathing Questionnaire, the Hospital anxiety and depression scale, and the Short-Form Survey Instrument, Breath-hold test, Lung function test, respiratory muscle function assessment. Days 2-8: Physical Activity Monitoring

Other: Short-form survey instrument; Other: Demographic data; Other: Hospital Anxiety and Depression Scale; Other: Nijmegen questionnaire; Other: The Self-evaluation of breathing questionnaire; Other: six-minute exercise test; Other: Indirect calorimetry; Other: Oxygen saturation monitoring; Other: Heart rate variability analysis; Other: Continuous measurement of arterial blood pressure; Diagnostic Test: Lung function test; Other: Respiratory muscle function; Other: Manual assessment of respiratory motion; Other: Breath-hold test; Other: Physical Activity monitoring

Restrictive lung disease group

Day 1: Hospital assessments (\~3 hours): Demographic data, Manual Assessment of Respiratory Motion, Slow-breathing task, Six-minute exercise test, Indirect calorimetry, Oxygen saturation monitoring, heart rate variability analysis, continuous measurement of arterial blood pressure, lung function test, the Nijmegen Questionnaire and the Self-Evaluation of Breathing Questionnaire, the Hospital anxiety and depression scale, and the Short-Form Survey Instrument, Breath-hold test, Lung function test, respiratory muscle function assessment. Days 2-8: Physical Activity Monitoring

Other: Short-form survey instrument; Other: Demographic data; Other: Hospital Anxiety and Depression Scale; Other: Nijmegen questionnaire; Other: The Self-evaluation of breathing questionnaire; Other: six-minute exercise test; Other: Indirect calorimetry; Other: Oxygen saturation monitoring; Other: Heart rate variability analysis; Other: Continuous measurement of arterial blood pressure; Diagnostic Test: Lung function test; Other: Respiratory muscle function; Other: Manual assessment of respiratory motion; Other: Breath-hold test; Other: Physical Activity monitoring

Primary dysfunctional Breathing group

Day 1: Hospital assessments (\~3 hours): Demographic data, Manual Assessment of Respiratory Motion, Slow-breathing task, Six-minute exercise test, Indirect calorimetry, Oxygen saturation monitoring, heart rate variability analysis, continuous measurement of arterial blood pressure, lung function test, the Nijmegen Questionnaire and the Self-Evaluation of Breathing Questionnaire, the Hospital anxiety and depression scale, and the Short-Form Survey Instrument, Breath-hold test, Lung function test, respiratory muscle function assessment. Days 2-8: Physical Activity Monitoring

Other: Short-form survey instrument; Other: Demographic data; Other: Hospital Anxiety and Depression Scale; Other: Nijmegen questionnaire; Other: The Self-evaluation of breathing questionnaire; Other: six-minute exercise test; Other: Indirect calorimetry; Other: Oxygen saturation monitoring; Other: Heart rate variability analysis; Other: Continuous measurement of arterial blood pressure; Diagnostic Test: Lung function test; Other: Respiratory muscle function; Other: Manual assessment of respiratory motion; Other: Breath-hold test; Other: Physical Activity monitoring

Secondary dysfunctional breathing group

Day 1: Hospital assessments (\~3 hours): Demographic data, Manual Assessment of Respiratory Motion, Slow-breathing task, Six-minute exercise test, Indirect calorimetry, Oxygen saturation monitoring, heart rate variability analysis, continuous measurement of arterial blood pressure, lung function test, the Nijmegen Questionnaire and the Self-Evaluation of Breathing Questionnaire, the Hospital anxiety and depression scale, Asthma Control Questionnaire, and the Short-Form Survey Instrument, Breath-hold test, Lung function test, respiratory muscle function assessment. Days 2-8: Physical Activity Monitoring

Other: Short-form survey instrument; Other: Demographic data; Other: Hospital Anxiety and Depression Scale; Other: Nijmegen questionnaire; Other: The Self-evaluation of breathing questionnaire; Other: six-minute exercise test; Other: Indirect calorimetry; Other: Oxygen saturation monitoring; Other: Heart rate variability analysis; Other: Continuous measurement of arterial blood pressure; Diagnostic Test: Lung function test; Other: Respiratory muscle function; Other: Manual assessment of respiratory motion; Other: Breath-hold test; Other: Physical Activity monitoring; Other: Asthma Control Questionnaire

Interventions

Short-form survey instrument OTHER

Questionnaire with questions about quality of life. Takes about 5 minutes to be completed.

Also known as: SF-36

Healthy participants; Primary dysfunctional Breathing group; Restrictive lung disease group; Secondary dysfunctional breathing group

Demographic data OTHER

height, weight, age, gender, list of comorbidities, health history, level of physical activity, medicines in use. Takes about 10 minutes to be completed.

Also known as: height, weight, age, gender

Healthy participants; Primary dysfunctional Breathing group; Restrictive lung disease group; Secondary dysfunctional breathing group

Hospital Anxiety and Depression Scale OTHER

Questionnaire with questions about anxiety and depression. Takes about 5 minutes to be completed.

Also known as: anxiety and depression questionnaire

Healthy participants; Primary dysfunctional Breathing group; Restrictive lung disease group; Secondary dysfunctional breathing group

Nijmegen questionnaire OTHER

Answering questions about symptoms related to breathing. Takes about 5 minutes to be completed.

Healthy participants; Primary dysfunctional Breathing group; Restrictive lung disease group; Secondary dysfunctional breathing group

The Self-evaluation of breathing questionnaire OTHER

Answering questions about self-evaluation of breathing. Takes about 5 minutes to be completed

Healthy participants; Primary dysfunctional Breathing group; Restrictive lung disease group; Secondary dysfunctional breathing group

six-minute exercise test OTHER

Cycling against certain load in a bicycle for 6 minutes. Takes about 16 minutes to be completed together with indirect calorimetry, oxygen saturation monitoring, heart rate variability analysis and continuous monitoring of arterial blood pressure).

Healthy participants; Primary dysfunctional Breathing group; Restrictive lung disease group; Secondary dysfunctional breathing group

Indirect calorimetry OTHER

Breathing through a mask that measures levels of oxygen, carbon dioxide, breathing frequency and others (non-invasively). Takes about 16 minutes to be completed, together with the 6-minute exercise test.

Also known as: gas analysis

Healthy participants; Primary dysfunctional Breathing group; Restrictive lung disease group; Secondary dysfunctional breathing group

Oxygen saturation monitoring OTHER

The measurement of the amount of oxygen which is attached to haemoglobin molecules (non-invasively). Takes about 16 minutes to be completed, together with the 6-minute exercise test.

Healthy participants; Primary dysfunctional Breathing group; Restrictive lung disease group; Secondary dysfunctional breathing group

Heart rate variability analysis OTHER

Measurement of the variation in the beat-to-beat interval (non-invasively). Takes about 16 minutes to be completed, together with the 6-minute exercise test.

Healthy participants; Primary dysfunctional Breathing group; Restrictive lung disease group; Secondary dysfunctional breathing group

Continuous measurement of arterial blood pressure OTHER

Measurement of blood pressure based on the peripheral pulse using a finger cuff (non-invasively). Takes about 16 minutes to be completed, together with the 6-minute exercise test.

Healthy participants; Primary dysfunctional Breathing group; Restrictive lung disease group; Secondary dysfunctional breathing group

Lung function test DIAGNOSTIC_TEST

Breathing through a mouth-piece in many different ways in order to measure the function of the lungs (non-invasively).

Healthy participants; Primary dysfunctional Breathing group; Restrictive lung disease group; Secondary dysfunctional breathing group

Respiratory muscle function OTHER

Breathing through a mouth-piece in many different ways in order to measure the function of the respiratory muscles (non-invasively).

Healthy participants; Primary dysfunctional Breathing group; Restrictive lung disease group; Secondary dysfunctional breathing group

Manual assessment of respiratory motion OTHER

Measure of the movements of the thorax while the participant is breathing (non-invasively).

Healthy participants; Primary dysfunctional Breathing group; Restrictive lung disease group; Secondary dysfunctional breathing group

Breath-hold test OTHER

Holding the breath a few times for as long as possible.

Healthy participants; Primary dysfunctional Breathing group; Restrictive lung disease group; Secondary dysfunctional breathing group

Physical Activity monitoring OTHER

Wearing a light-weight activity monitor to be wore on the hip for 7 consecutive days during, at least, 8 hours per day.

Healthy participants; Primary dysfunctional Breathing group; Restrictive lung disease group; Secondary dysfunctional breathing group

Asthma Control Questionnaire OTHER

Only for asthmatics: answering questions about the control the participant has over this respiratory condition/symptoms.

Secondary dysfunctional breathing group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary/secondary dysfunctional breathing and patients with restrictive lung diseases will be recruited from clinics of respiratory medicine (secondary care). Healthy participants will be recruited from the general population (at Brunel University London).

You may qualify if:

• patients with DB (according to the CD)
• healthy people
• aged 18 or over,
• must be able to comprehend and/or perform the procedures of this research
• must be able to consent to participate
• people with signs of breathlessness secondary to restrictive lung disease (DB excluded)

You may not qualify if:

• people whose condition is unstable or have experienced an exacerbation of symptoms over the last 4 weeks
• patients who are oxygen-dependant (at rest or during exercise),
• those who are on oral steroids or have completed a course of those medications less than four weeks prior to the assessment day,
• those who have major orthopaedic, neurological or cardiac conditions
• those who received breathing retraining before

Sponsors & Collaborators

• Brunel University: lead
• University of Sao Paulo: collaborator

Study Sites (1)

Brunel University London

London, Middlesex, UB83PH, United Kingdom

Location

Related Publications (64)

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MeSH Terms

Conditions

Respiration Disorders; Dyspnea

Interventions

Demography; Body Height; Weights and Measures; Aging; Sex; 4-amino-4'-hydroxylaminodiphenylsulfone; Patient Health Questionnaire; Exercise Test; Calorimetry, Indirect; Respiratory Function Tests

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health; Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Appearance, Body; Anthropometry; Investigative Techniques; Physiological Phenomena; Growth; Growth and Development; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques, Respiratory System; Ergometry; Calorimetry; Chemistry Techniques, Analytical

Study Officials

• Panagiota Smyrni, Dr

  Brunel University London

  STUDY CHAIR

Central Study Contacts

Lais S Vidotto, Ms

CONTACT

4401895278024; lais.vidotto@brunel.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ms Lais Silva Vidotto

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 6, 2017
• Study Start: August 8, 2020
• Primary Completion: April 30, 2021
• Study Completion: May 30, 2021
• Last Updated: July 8, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)