Breathlessness Clinical Trial
Official title:
Dysfunctional Breathing: Multidimensional Characterisation and Assessment Tool
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).
Status | Not yet recruiting |
Enrollment | 141 |
Est. completion date | May 30, 2021 |
Est. primary completion date | April 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Brunel University London | London | Middlesex |
Lead Sponsor | Collaborator |
---|---|
Brunel University | University of Sao Paulo |
United Kingdom,
Aadland E, Ylvisåker E. Reliability of the Actigraph GT3X+ Accelerometer in Adults under Free-Living Conditions. PLoS One. 2015 Aug 14;10(8):e0134606. doi: 10.1371/journal.pone.0134606. eCollection 2015. — View Citation
ASTRAND PO, RYHMING I. A nomogram for calculation of aerobic capacity (physical fitness) from pulse rate during sub-maximal work. J Appl Physiol. 1954 Sep;7(2):218-21. — View Citation
Barker N, Everard ML. Getting to grips with 'dysfunctional breathing'. Paediatr Respir Rev. 2015 Jan;16(1):53-61. doi: 10.1016/j.prrv.2014.10.001. Epub 2014 Nov 25. Review. — View Citation
Barker NJ, Jones M, O'Connell NE, Everard ML. Breathing exercises for dysfunctional breathing/hyperventilation syndrome in children. Cochrane Database Syst Rev. 2013 Dec 18;(12):CD010376. doi: 10.1002/14651858.CD010376.pub2. Review. — View Citation
Bernardi L, Porta C, Gabutti A, Spicuzza L, Sleight P. Modulatory effects of respiration. Auton Neurosci. 2001 Jul 20;90(1-2):47-56. Review. — View Citation
Bernardi L, Wdowczyk-Szulc J, Valenti C, Castoldi S, Passino C, Spadacini G, Sleight P. Effects of controlled breathing, mental activity and mental stress with or without verbalization on heart rate variability. J Am Coll Cardiol. 2000 May;35(6):1462-9. — View Citation
Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. Review. — View Citation
Bogert LW, van Lieshout JJ. Non-invasive pulsatile arterial pressure and stroke volume changes from the human finger. Exp Physiol. 2005 Jul;90(4):437-46. Epub 2005 Mar 31. Review. — View Citation
Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81. — View Citation
Bott J, Blumenthal S, Buxton M, Ellum S, Falconer C, Garrod R, Harvey A, Hughes T, Lincoln M, Mikelsons C, Potter C, Pryor J, Rimington L, Sinfield F, Thompson C, Vaughn P, White J; British Thoracic Society Physiotherapy Guideline Development Group. Guidelines for the physiotherapy management of the adult, medical, spontaneously breathing patient. Thorax. 2009 May;64 Suppl 1:i1-51. doi: 10.1136/thx.2008.110726. — View Citation
Brashear RE. Hyperventilation syndrome. Lung. 1983;161(5):257-73. Review. — View Citation
Brijker F, van den Elshout FJ, Heijdra YF, Bosch FH, Folgering HT. Effect of acute metabolic acid/base shifts on the human airway calibre. Respir Physiol. 2001 Jan;124(2):151-8. — View Citation
Combes P, Fauvage B. Combined effects of hypocapnia and nicardipine on airway resistance: a pilot study. Eur J Clin Pharmacol. 1997;51(5):385-8. — View Citation
Courtney R, Cohen M. Investigating the claims of Konstantin Buteyko, M.D., Ph.D.: the relationship of breath holding time to end tidal CO2 and other proposed measures of dysfunctional breathing. J Altern Complement Med. 2008 Mar;14(2):115-23. doi: 10.1089/acm.2007.7204. — View Citation
Courtney R, Greenwood KM, Cohen M. Relationships between measures of dysfunctional breathing in a population with concerns about their breathing. J Bodyw Mov Ther. 2011 Jan;15(1):24-34. doi: 10.1016/j.jbmt.2010.06.004. Epub 2010 Jul 16. — View Citation
Courtney R, van Dixhoorn J, Cohen M. Evaluation of breathing pattern: comparison of a Manual Assessment of Respiratory Motion (MARM) and respiratory induction plethysmography. Appl Psychophysiol Biofeedback. 2008 Jun;33(2):91-100. doi: 10.1007/s10484-008-9052-3. Epub 2008 Mar 5. — View Citation
Courtney R, van Dixhoorn J, Greenwood KM, Anthonissen EL. Medically unexplained dyspnea: partly moderated by dysfunctional (thoracic dominant) breathing pattern. J Asthma. 2011 Apr;48(3):259-65. doi: 10.3109/02770903.2011.554942. Epub 2011 Feb 22. — View Citation
de Groot EP, Duiverman EJ, Brand PL. Dysfunctional breathing in children with asthma: a rare but relevant comorbidity. Eur Respir J. 2013 May;41(5):1068-73. doi: 10.1183/09031936.00130212. Epub 2012 Sep 27. — View Citation
Gridina I, Bidat E, Chevallier B, Stheneur C. [Prevalence of chronic hyperventilation syndrome in children and teenagers]. Arch Pediatr. 2013 Mar;20(3):265-8. doi: 10.1016/j.arcped.2012.12.016. Epub 2013 Feb 1. French. — View Citation
Guelen I, Westerhof BE, Van Der Sar GL, Van Montfrans GA, Kiemeneij F, Wesseling KH, Bos WJ. Finometer, finger pressure measurements with the possibility to reconstruct brachial pressure. Blood Press Monit. 2003 Feb;8(1):27-30. — View Citation
Hagman C, Janson C, Emtner M. A comparison between patients with dysfunctional breathing and patients with asthma. Clin Respir J. 2008 Apr;2(2):86-91. doi: 10.1111/j.1752-699X.2007.00036.x. — View Citation
Hagman C, Janson C, Emtner M. Breathing retraining - a five-year follow-up of patients with dysfunctional breathing. Respir Med. 2011 Aug;105(8):1153-9. doi: 10.1016/j.rmed.2011.03.006. Epub 2011 Mar 31. — View Citation
Han JN, Stegen K, Simkens K, Cauberghs M, Schepers R, Van den Bergh O, Clément J, Van de Woestijne KP. Unsteadiness of breathing in patients with hyperventilation syndrome and anxiety disorders. Eur Respir J. 1997 Jan;10(1):167-76. — View Citation
Hawkes EZ, Nowicky AV, McConnell AK. Diaphragm and intercostal surface EMG and muscle performance after acute inspiratory muscle loading. Respir Physiol Neurobiol. 2007 Mar 15;155(3):213-9. Epub 2006 Jul 18. — View Citation
Healy GN, Clark BK, Winkler EA, Gardiner PA, Brown WJ, Matthews CE. Measurement of adults' sedentary time in population-based studies. Am J Prev Med. 2011 Aug;41(2):216-27. doi: 10.1016/j.amepre.2011.05.005. Review. — View Citation
Homma I, Masaoka Y. Breathing rhythms and emotions. Exp Physiol. 2008 Sep;93(9):1011-21. doi: 10.1113/expphysiol.2008.042424. Epub 2008 May 16. Review. — View Citation
Howell JB. The hyperventilation syndrome: a syndrome under threat? Thorax. 1997 Aug;52 Suppl 3:S30-4. Review. — View Citation
Imholz BP, Wieling W, van Montfrans GA, Wesseling KH. Fifteen years experience with finger arterial pressure monitoring: assessment of the technology. Cardiovasc Res. 1998 Jun;38(3):605-16. Review. — View Citation
Jack S, Rossiter HB, Pearson MG, Ward SA, Warburton CJ, Whipp BJ. Ventilatory responses to inhaled carbon dioxide, hypoxia, and exercise in idiopathic hyperventilation. Am J Respir Crit Care Med. 2004 Jul 15;170(2):118-25. Epub 2004 Apr 1. — View Citation
Jenkinson C, Stewart-Brown S, Petersen S, Paice C. Assessment of the SF-36 version 2 in the United Kingdom. J Epidemiol Community Health. 1999 Jan;53(1):46-50. — View Citation
Jones M, Harvey A, Marston L, O'Connell NE. Breathing exercises for dysfunctional breathing/hyperventilation syndrome in adults. Cochrane Database Syst Rev. 2013 May 31;(5):CD009041. doi: 10.1002/14651858.CD009041.pub2. Review. — View Citation
Jones M, Troup F, Nugus J, Roughton M, Hodson M, Rayner C, Bowen F, Pryor J. Does manual therapy provide additional benefit to breathing retraining in the management of dysfunctional breathing? A randomised controlled trial. Disabil Rehabil. 2015;37(9):763-70. doi: 10.3109/09638288.2014.941020. Epub 2014 Jul 15. — View Citation
Joseph CN, Porta C, Casucci G, Casiraghi N, Maffeis M, Rossi M, Bernardi L. Slow breathing improves arterial baroreflex sensitivity and decreases blood pressure in essential hypertension. Hypertension. 2005 Oct;46(4):714-8. Epub 2005 Aug 29. — View Citation
Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999 Oct;14(4):902-7. — View Citation
Kozey-Keadle S, Libertine A, Lyden K, Staudenmayer J, Freedson PS. Validation of wearable monitors for assessing sedentary behavior. Med Sci Sports Exerc. 2011 Aug;43(8):1561-7. doi: 10.1249/MSS.0b013e31820ce174. — View Citation
Legge BJ, Banister EW. The Astrand-Ryhming nomogram revisited. J Appl Physiol (1985). 1986 Sep;61(3):1203-9. — View Citation
Lehrer PM, Vaschillo E, Vaschillo B. Resonant frequency biofeedback training to increase cardiac variability: rationale and manual for training. Appl Psychophysiol Biofeedback. 2000 Sep;25(3):177-91. — View Citation
LEWIS BI. Hyperventilation syndrome: a clinical and physiological evaluation. Calif Med. 1959 Sep;91:121-6. — View Citation
Lum LC. Hyperventilation and anxiety state. J R Soc Med. 1981 Jan;74(1):1-4. — View Citation
Lyden K, Kozey Keadle SL, Staudenmayer JW, Freedson PS. Validity of two wearable monitors to estimate breaks from sedentary time. Med Sci Sports Exerc. 2012 Nov;44(11):2243-52. doi: 10.1249/MSS.0b013e318260c477. — View Citation
Macsween A. The reliability and validity of the Astrand nomogram and linear extrapolation for deriving VO2max from submaximal exercise data. J Sports Med Phys Fitness. 2001 Sep;41(3):312-7. — View Citation
Magarian GJ. Hyperventilation syndromes: infrequently recognized common expressions of anxiety and stress. Medicine (Baltimore). 1982 Jul;61(4):219-36. Review. — View Citation
Matthews CE, Chen KY, Freedson PS, Buchowski MS, Beech BM, Pate RR, Troiano RP. Amount of time spent in sedentary behaviors in the United States, 2003-2004. Am J Epidemiol. 2008 Apr 1;167(7):875-81. doi: 10.1093/aje/kwm390. Epub 2008 Feb 25. — View Citation
McConnell AK, Copestake AJ. Maximum static respiratory pressures in healthy elderly men and women: issues of reproducibility and interpretation. Respiration. 1999;66(3):251-8. — View Citation
Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. — View Citation
Mitchell AJ, Bacon CJ, Moran RW. Reliability and Determinants of Self-Evaluation of Breathing Questionnaire (SEBQ) Score: A Symptoms-Based Measure of Dysfunctional Breathing. Appl Psychophysiol Biofeedback. 2016 Mar;41(1):111-20. doi: 10.1007/s10484-015-9316-7. — View Citation
Morgan MD. Dysfunctional breathing in asthma: is it common, identifiable and correctable? Thorax. 2002 Oct;57 Suppl 2:II31-II35. — View Citation
Murias JM, Kowalchuk JM, Paterson DH. Speeding of VO2 kinetics with endurance training in old and young men is associated with improved matching of local O2 delivery to muscle O2 utilization. J Appl Physiol (1985). 2010 Apr;108(4):913-22. doi: 10.1152/japplphysiol.01355.2009. Epub 2010 Feb 11. — View Citation
Peroni DG, Piacentini GL, Bodini A, Boner AL. Childhood Asthma Control Test in asthmatic children with dysfunctional breathing. J Allergy Clin Immunol. 2008 Jan;121(1):266-7; author reply 267. Epub 2007 Oct 17. — View Citation
Quanjer PH, Tammeling GJ, Cotes JE, Pedersen OF, Peslin R, Yernault JC. Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory Society. Eur Respir J Suppl. 1993 Mar;16:5-40. Review. — View Citation
RAHN H, OTIS AB, et al. The pressure-volume diagram of the thorax and lung. Am J Physiol. 1946;146(2):161-78. — View Citation
Sclauser Pessoa IM, Franco Parreira V, Fregonezi GA, Sheel AW, Chung F, Reid WD. Reference values for maximal inspiratory pressure: a systematic review. Can Respir J. 2014 Jan-Feb;21(1):43-50. Epub 2013 Oct 17. Review. — View Citation
Stanojevic S, Wade A, Stocks J. Reference values for lung function: past, present and future. Eur Respir J. 2010 Jul;36(1):12-9. doi: 10.1183/09031936.00143209. — View Citation
Thomas M, McKinley RK, Freeman E, Foy C, Price D. The prevalence of dysfunctional breathing in adults in the community with and without asthma. Prim Care Respir J. 2005 Apr;14(2):78-82. — View Citation
Thomas M, McKinley RK, Freeman E, Foy C. Prevalence of dysfunctional breathing in patients treated for asthma in primary care: cross sectional survey. BMJ. 2001 May 5;322(7294):1098-100. — View Citation
van Dixhoorn J, Duivenvoorden HJ. Efficacy of Nijmegen Questionnaire in recognition of the hyperventilation syndrome. J Psychosom Res. 1985;29(2):199-206. — View Citation
van Dixhoorn J, Folgering H. The Nijmegen Questionnaire and dysfunctional breathing. ERJ Open Res. 2015 May 15;1(1). pii: 00001-2015. eCollection 2015 May. — View Citation
Vansteenkiste J, Rochette F, Demedts M. Diagnostic tests of hyperventilation syndrome. Eur Respir J. 1991 Apr;4(4):393-9. — View Citation
Volianitis S, McConnell AK, Jones DA. Assessment of maximum inspiratory pressure. Prior submaximal respiratory muscle activity ('warm-up') enhances maximum inspiratory activity and attenuates the learning effect of repeated measurement. Respiration. 2001;68(1):22-7. — View Citation
Warburton CJ, Jack S. Can you diagnose hyperventilation? Chron Respir Dis. 2006;3(3):113-5. — View Citation
Ware JE Jr, Gandek B. Overview of the SF-36 Health Survey and the International Quality of Life Assessment (IQOLA) Project. J Clin Epidemiol. 1998 Nov;51(11):903-12. — View Citation
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83. — View Citation
Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. Review. — View Citation
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. — View Citation
* Note: There are 64 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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.. | |
Primary | 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. | |
Primary | 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 | Medical History | Participants will be asked about their medical history, health conditions, comorbidities, medicines in use and its doses. | This assessment will be applied during the 3-hour assessment, and takes about 5 minutes to be completed. | |
Secondary | Age | The date of birth (age) of the participants will be recorded and used for analyses. | This assessment will be applied during the 3-hour assessment, and takes about 20 seconds to be completed. | |
Secondary | Gender | The gender of the participants will be recorded and used for analyses. | This assessment will be applied during the 3-hour assessment, and takes about 10 seconds to be completed. | |
Secondary | Weight | The weight of the participants will be recorded based on self-report. | This assessment will be applied during the 3-hour assessment, and takes about 10 seconds to be completed. | |
Secondary | Height | The height of the participants will be recorded based on self-report. | This assessment will be applied during the 3-hour assessment, and takes about 10 seconds to be completed. | |
Secondary | Body mass index (BMI) | The body mass index of the participants will be calculated as follows: weight over height squared. | The BMI will be calculated based on height and weight collected from the participants, and will take about 1 minute to be calculated. | |
Secondary | Level of physical activity | The level of physical activity of the participants will be recorded based on self-report. They will be asked how many days of a typical week they participate in moderate-to-vigorous physical activity. Also, they will be asked how many minutes per day, during a typical week, they participate in moderate-to-vigorous physical activity. Finally, participants will be asked about any sports that they have participated in and at what level. | This assessment will be applied during the 3-hour assessment, and takes about 3 minutes to be completed. | |
Secondary | Forced vital capacity (FVC) | Lung function will be assessed by spirometry, as hypocapnia is associated with bronchoconstriction (Combes and Fauvage 1997, Brijker et al. 2001). Forced vital capacity (FVC) will be assessed following international recommendations (Miller et al. 2005) and the reference values will be calculated according to Quanjer et al. (1993) and Stanojevic et al. (2010). The participant will be instructed to exhale the maximum possible until residual volume and to inspire as rapid as possible, aiming a maximal and quick gasp until at least 50% of vital capacity. | This assessment will be applied during the 3-hour assessment, and takes about 10 minutes to be completed. | |
Secondary | Forced expiratory volume in the first second (FEV1) | Lung function will be assessed by spirometry, as hypocapnia is associated with bronchoconstriction (Combes and Fauvage 1997, Brijker et al. 2001). Forced expiratory volume in the first second (FEV1) will be assessed following international recommendations (Miller et al. 2005) and the reference values will be calculated according to Quanjer et al. (1993) and Stanojevic et al. (2010). The participant will be instructed to exhale the maximum possible until residual volume and to inspire as rapid as possible, aiming a maximal and quick gasp until at least 50% of vital capacity. | This assessment will be applied during the 3-hour assessment, and takes about 10 minutes to be completed. | |
Secondary | Maximum voluntary ventilation (MVV) | Lung function will be assessed by spirometry, as hypocapnia is associated with bronchoconstriction (Combes and Fauvage 1997, Brijker et al. 2001). Forced expiratory volume in the first second (FEV1) will be assessed following international recommendations (Miller et al. 2005) and the reference values will be calculated according to Quanjer et al. (1993) and Stanojevic et al. (2010). The participant will be instructed to ventilate with her or his maximal ventilation volume and frequency, inhaling and exhaling as deep and quick as possible. | This assessment will be applied during the 3-hour assessment, and takes about 10 minutes to be completed. | |
Secondary | Peak inspiratory flow rate | The peak inspiratory flow rate will be measured based on the protocol described by McConnell (McConnell 2013). The participant will be instructed to exhale the maximum possible until residual volume and to inspire as rapid as possible, aiming a maximal and quick gasp until at least 50% of vital capacity. | This assessment will be applied during the 3-hour assessment, and takes about 10 minutes to be completed (together with the FVC, since this outcome is provided by the same manoeuvre). | |
Secondary | Peak expiratory flow rate | The peak expiratory flow rate will be measured based on the protocol described by McConnell (McConnell 2013). The participant will be instructed to inhale the maximum possible until total vital capacity and to expire as rapid as possible, aiming a maximal and quick manoeuvre. | This assessment will be applied during the 3-hour assessment, and takes about 10 minutes to be completed. | |
Secondary | Inspiratory muscle function | Inspiratory muscle strength will be assessed by the maximal inspiratory pressure (MIP) measurement (McConnell and Copestake 1999, Volianitis et al. 2001) using a mouth pressure meter (Micro Medical RPM, Carefusion, San Diego, United States). The protocol to assess inspiratory muscle strength will be the one described by Black and Hyatt (1969), in which MIP is measured starting at residual volume (McConnell 2013). During the manoeuvre the participants will be instructed to sustain a maximal effort for at least 1.5-2.0 seconds, and a minimum of 5 satisfactory efforts will be considered according to Volianitis et al. (2001). | This assessment will be applied during the 3-hour assessment, and takes about 30 minutes to be completed. | |
Secondary | Expiratory muscle function | Expiratory muscle strength will be assessed by the maximal expiratory pressure (MEP) measurement (McConnell and Copestake 1999, Volianitis et al. 2001) using a mouth pressure meter (Micro Medical RPM, Carefusion, San Diego, United States). The protocol to assess expiratory muscle strength will be the one described by Black and Hyatt (1969), in which MEP is measured starting at total lung capacity (McConnell 2013). During the manoeuvre the participants will be instructed to sustain a maximal effort for at least 1.5-2.0 seconds, and a minimum of 5 satisfactory efforts will be considered according to Volianitis et al. (2001). | This assessment will be applied during the 3-hour assessment, and takes about 30 minutes to be completed. | |
Secondary | Exercise capacity | The Astrand-Ryhming submaximal test (Astrand and Ryhming 1954) will be used to assess exercise capacity of all participants and to predict maximal oxygen uptake. Participants will be instructed to stay 48 hours previous to the test without practicing exercise. This test will be performed on a cycle ergometer and power outputs of 75 to 150 watts and 100 to 200 watts will be used for women and men, respectively. The rotation of 50 rpm needs to be kept for 6 minutes. The HR is registered at the 5th and 6th minutes of the exercise test, and with the right load, these values cannot differentiate from each other more than 5 bpm. After that, a mathematic model will be used to predict the maximal oxygen uptake (Astrand and Ryhming 1954, Legge and Banister 1986, Macsween 2001). | This assessment will be applied during the 3-hour assessment, and takes about 16 minutes to be completed (simultaneously with the levels of heart rate variability, arterial blood pressure and gas exchange). | |
Secondary | Level of heart rate variability | The heart rate variability (HRV) will be continuously assessed during five minutes before, during, and five minutes after the exercise test and during a controlled breathing of approximately 6-10 breaths per minute. HRV will be assessed by using a Polar® V800 device (Polar, Kempele-Finland), and the heart's electrical signal will be processed by using Kubios HRV version 2.2. The data will be initially filtered and smoothed to obtain heart rate frequency mean, time-domain analyses of the R-R intervals (interval between 2 "R" curves in the electrocardiogram (e.g., standard deviation of normal-to-normal RR intervals [SDNN] and root mean square of successive differences [RMSSD]) and spectral analyses of frequency indices (i.e., very low-frequency [0-0.04], low-frequency [0.04-0.15 Hz] and high-frequency [0.15-0.4 Hz]) aiming the further understanding of the autonomic nervous system responses in DB. | This assessment will be applied during the 3-hour assessment, and takes about 15 minutes to be placed and will be continuously used during the exercise test (16 minutes) and the slow-breathing task (15 minutes). | |
Secondary | Level of arterial blood pressure | The arterial blood pressure (ABP) will be continuously assessed during five minutes before, during, and five minutes after the exercise test and during a controlled breathing of approximately 6-10 breaths per minute. Finger ABP will be measured by the use of Finometer 1.10 (Finapres Medical System, Amsterdam - The Netherlands), which non-invasively registers continuous blood pressure measurements. The finger pressure generates a waveform and the ABP is exported based on calculations built every heartbeat (Bogert and van Lieshout 2005). Finger ABP signals will be processed by using the Lab Chart Pro Software, which records, displays and analyses real time data from up to 32 channels. | This assessment will be applied during the 3-hour assessment, and takes about 15 minutes to be placed and will be continuously used during the exercise test (16 minutes) and the slow-breathing task (15 minutes). | |
Secondary | Minute volume | The indirect calorimetry (IC) will be performed by the portable system K5® (Cosmed, Rome, Italy). This ergospirometer calculates breath-by-breath oscillations of minute volume (VE). The device will be attached to the participant's chest and a facemask, which has less than 30 ml of dead space, suitably adjusted to eliminate air leakage. The equipment will be programmed to assess data breath-by-breath and an average will be recorded every 5 seconds. Oxycon Pro software will be used to process the data for further analyses. | This assessment will be applied during the 3-hour assessment, and takes about 15 minutes to be placed and will be continuously used during the exercise test (16 minutes) and the slow-breathing task (15 minutes). | |
Secondary | Oxygen Uptake | The indirect calorimetry (IC) will be performed by the portable system K5® (Cosmed, Rome, Italy). This ergospirometer calculates breath-by-breath oscillations of oxygen uptake (O2). The device will be attached to the participant's chest and a facemask, which has less than 30 ml of dead space, suitably adjusted to eliminate air leakage. The equipment will be programmed to assess data breath-by-breath and an average will be recorded every 5 seconds. Oxycon Pro software will be used to process the data for further analyses. | This assessment will be applied during the 3-hour assessment, and takes about 15 minutes to be placed and will be continuously used during the exercise test (16 minutes) and the slow-breathing task (15 minutes). | |
Secondary | Carbon dioxide | The indirect calorimetry (IC) will be performed by the portable system K5® (Cosmed, Rome, Italy). This ergospirometer calculates breath-by-breath oscillations of carbon dioxide (CO2). The device will be attached to the participant's chest and a facemask, which has less than 30 ml of dead space, suitably adjusted to eliminate air leakage. The equipment will be programmed to assess data breath-by-breath and an average will be recorded every 5 seconds. Oxycon Pro software will be used to process the data for further analyses. | This assessment will be applied during the 3-hour assessment, and takes about 15 minutes to be placed and will be continuously used during the exercise test (16 minutes) and the slow-breathing task (15 minutes). | |
Secondary | Respiratory exchange ratio | The indirect calorimetry (IC) will be performed by the portable system K5® (Cosmed, Rome, Italy). This ergospirometer calculates breath-by-breath oscillations of respiratory exchange ratio (RER). The device will be attached to the participant's chest and a facemask, which has less than 30 ml of dead space, suitably adjusted to eliminate air leakage. The equipment will be programmed to assess data breath-by-breath and an average will be recorded every 5 seconds. Oxycon Pro software will be used to process the data for further analyses. | This assessment will be applied during the 3-hour assessment, and takes about 15 minutes to be placed and will be continuously used during the exercise test (16 minutes) and the slow-breathing task (15 minutes). | |
Secondary | Respiratory rate | The indirect calorimetry (IC) will be performed by the portable system K5® (Cosmed, Rome, Italy). This ergospirometer calculates breath-by-breath oscillations of respiratory rate (breaths per minute - BPM). The device will be attached to the participant's chest and a facemask, which has less than 30 ml of dead space, suitably adjusted to eliminate air leakage. The equipment will be programmed to assess data breath-by-breath and an average will be recorded every 5 seconds. Oxycon Pro software will be used to process the data for further analyses. | This assessment will be applied during the 3-hour assessment, and takes about 15 minutes to be placed and will be continuously used during the exercise test (16 minutes) and the slow-breathing task (15 minutes). | |
Secondary | Attentional focus | Attentional focus (Attention Scale [AS]; Tammen 1996, Tenenbaum et al. 2007) will be measured at various time points (pre exercise, at the 3rd minute, and at the end of the exercise test) during the execution of the six-minute cycling test described above. | This assessment will be applied 3 times during the exercise test, and takes about 30 seconds to be completed each time. So, it will take approximately 1 minute and 30 seconds to be applied in total. | |
Secondary | Level of fatigue | Limb discomfort (Category Ratio 10 [CR10-fatigue]; Borg 1982) (Borg Scale fatigue) will be measured at various time points (pre exercise, at the 3rd minute, and at the end of the exercise test) during the execution of the six-minute cycling test described above. | This assessment will be applied 3 times during the exercise test, and takes about 15 seconds to be completed each time. So, it will take approximately 45 seconds to be applied in total. | |
Secondary | Level of dyspnoea | Dyspnoea (CR10-dyspnoea; Borg 1982) (Borg Scale dyspnoea) will be measured at various time points (pre exercise, at the 3rd minute, and at the end of the exercise test) during the execution of the six-minute cycling test described above. | This assessment will be applied 3 times during the exercise test, and takes about 15 seconds to be completed each time. So, it will take approximately 45 seconds to be applied in total. |
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