Chronic Obstructive Pulmonary DiseaseNCT03848819
Effect of Portable NIV on Operational Chest Wall Volumes in COPD
A study testing VitaBreath device in people with Chronic Obstructive Pulmonary Disease, run by Northumbria University at 1 site in United Kingdom.
Trial summary
The VitaBreath (Philips, Respironics) is a portable, handheld, battery powered, non-invasive ventilation device, that has been shown to reduce activity-related shortness of breath in patients with COPD. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- VitaBreath device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2019to 29 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 40 years or older.
- Current or previous smoking history: 10 or more pack years.
- Spirometry confirmed stable COPD (GOLD stages II-IV) under optimal medical therapy.
- Exhibit substantial exercise-induced dynamic hyperinflation (ΔIC baseline > 0,150 L)
Who cannot join
- Orthopaedic, neurological or other concomitant diseases that significantly impair normal biomechanical movement patterns, as judged by the investigator.
- Moderate or severe COPD exacerbation within 6 weeks.
- Unstable cardiac arrhythmia.
- Unstable ischaemic heart disease, including myocardial infarction within 6 weeks.
- Moderate or severe aortic stenosis or hypertrophic obstructive cardiomyopathy.
- Uncontrolled hypertension.
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- Uncontrolled hypotension (SBP<85mmHg).
- Uncontrolled diabetes.
- Intolerance of the VitaBreath device.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, NE1 8ST
About this study
Official title: Effect of the VitaBreath Device on Chest Wall Dynamic Hyperinflation and Respiratory Muscle Activation During Recovery From Exercise in Patients With Chronic Obstructive Pulmonary Disease
The VitaBreath (Philips, Respironics) is a portable, handheld, battery powered, non-invasive ventilation device, that has been shown to reduce activity-related shortness of breath in patients with COPD. The VitaBreath device delivers 18 cmH2O inspiratory and 8 cmH2O expiratory pressures, but can only be used during recovery periods.
A previous study (REC: 17/NE/0085) showed that use of the VitaBreath device during the recovery periods interspersing successive exercise bouts enhances exercise tolerance and reduces breathlessness compared to pursed lip breathing in patients with COPD. This was attributed to faster recovery from exercise-induced dynamic hyperinflation, assessed by volitional inspiratory capacity manoeuvres using a spirometer. However, inspiratory capacity manoeuvres are effort dependent, thus limiting the number of repetitions the patient can perform during exercise. In addition, investigation of the direct effect of the application of the VitaBreath device on dynamic hyperinflation was not possible due to the need to employ a spirometer for assessing inspiratory capacity. Optoelectronic plethysmography (OEP) allows continuous non-invasive assessment of end-inspiratory and end-expiratory volumes of the thoracoabdominal wall and its compartments, thereby facilitating assessment of dynamic hyperinflation on a breath-by-breath basis without the necessity to breathe via a spirometer. Unfortunately, OEP technology was not available at the time of our previous study.
Read more
The investigators will use OEP to provide accurate breath-by-breath volume measurements during exercise and recovery to evaluate whether the VitaBreath device reduces total and compartmental thoracoabdominal wall volumes compared to the pursed lip breathing technique.
Furthermore, the investigators will investigate the effect of use of the VitaBreath device on respiratory muscle activation and respiratory muscle oxygenation using OEP technology in conjunction with electromyography (EMG) and near inferred spectroscopy (NIRS), respectively to appreciate how the application of the VitaBreath device impacts on the operation and energy demands of the respiratory muscles as compared to control pursed lip breathing.
The investigators hypothesised that the use of the VitaBreath device during the recovery periods interspersing successive exercise bouts will reduce the magnitude of dynamic hyperinflation in a greater extent compared to the pursed lip breathing technique.
Read the detailed description
Study Design:
This is a randomised crossover trial. Patients will perform two identical exercise tests and the intervention (VitaBreath) will be compared to control condition (pursed-lip breathing) in the same patients. The order of testing will be determined by simple randomisation (sealedenvelope.com).
The purpose of this study is to investigate the effect of the VitaBreath device on inspiratory and expiratory thoracoabdominal wall volumes during exercise in patients with COPD. Use of the VitaBreath device will be compared to normal breathing (pursed lip breathing technique). Patients will primarily be recruited from those who participated in our previous study (REC reference: 17/NE/0085 - IRAS project ID: 221120) at North Tyneside General Hospital and will undergo two exercise tests on a cycle ergometer on the same day using both the VitaBreath device and the pursed-lip breathing technique during recovery from exercise.
Study interventions:
The study will include two visits. During the first visit patients will undergo a clinical assessment, including history, physical examination, ECG and full lung function assessment including spirometry, to ensure that patients are stable. During the second visit patients will perform two intermittent exercise tests lasting 20 minutes each and consisting of 2-min work bouts at 80% of peak work rate (WR peak) as determined in the previous study (REC reference: 17/NE/0085 - IRAS project ID: 221120) with 2-min recovery periods in between work bouts, using either the VitaBreath device or the pursed lip breathing technique during recovery periods. Patients will be given written information explaining the procedure and will provide written informed consent.
Assessment Procedures
Visit 1
Baseline assessment
During the first visit patients will undergo the following baseline assessment: a) medical history and physical examination, b) spirometry and c) resting ECG to assess the resting heart function.
Visit 2
Preparation of the patients
Upon arrival to the laboratory, and prior to any intervention, adhesive skin markers for Opto-Electronic Plethysmography (OEP) recordings (to assess thoracoabdominal wall dynamic hyperinflation), and set of adhesive optodes for portable cardio-impedance recordings (to assess cardiac output), muscle surface electromyography (to assess muscle recruitment patterns) and near inferred spectroscopy (to assess respiratory muscle oxygen requirement) will be attached on the skin. All procedures will be explained in detail prior each trial.
Operational chest wall volumes
At baseline, patients will be instructed after 3-4 regular tidal breaths to make two maximal inspiratory capacity (IC) efforts from End Expiratory Chest Wall (EECW) Volume to Total Chest Wall Capacity (TLCCW) in order to assess chest wall volume at TLC (TLCCW) and Inspiratory Reserve Chest wall Volume (IRVcw) at rest. During exercise and recovery, chest wall kinematics will be measured by OEP as follows: the movement of 89 retro-reflective markers placed front and back over the chest wall from clavicles to pubis will be recorded. Each marker will be tracked by eight video cameras (Smart System BTS, Milan, Italy), four in front of the subject and four behind. Subjects will be grasp handles positioned at the mid sternum level which will lift the arms away from the rib cage so that lateral markers can be visualised. Dedicated software reconstructs the three-dimensional coordinates of the markers in real time by stereophotogrametry and calculates total and compartmental chest wall volume and volume variations using Gauss's theorem. The chest wall is modelled as being composed of two compartments-the rib cage and the abdomen. Vcw is the sum of the rib cage volume (Vrc) and abdominal volume (Vab).
Non-Invasive assessment of respiratory muscle oxygenation
In addition to operational chest wall volumes investigators are going to assess intercostal and abdominal local muscle oxygenation using Near-Infrared Spectroscopy (NIRS). Two NIRS optodes, which will be connected to a NIRO 200 spectrophotometer (Hamamatsu Photonics, Hamamatsu, Japan), will be placed on the skin over the left seventh intercostal space at the midaxillary line and over the upper rectus abdominis respectively, and will be secured using adhesive tape. The left intercostal space will be used to avoid potential blood flow contributions from the liver on the right side of the body.
Respiratory muscle electromyography
Electromyography (EMG) will be used in order assess respiratory muscle activation. Skin will be cleaned and surface electrodes (Delsys Trigno, Delsys, Boston, MA, USA) will be placed as follows: on the surface over the right seventh intercostal space (EMGic), 2 cm lateral to the umbilicus, over the muscle mass of rectus abdominis (EMGra), over the sternocleidomastoid muscle (EMGster), and on the scalene muscle (EMGsca). EMG data will be recorded at 2000Hz and will be filtered at 25-500 Hz during each trial (Spike 2, Cambridge Electronic Design, Cambridge, UK).
Exercise protocol
Patients will undergo two intermittent exercise protocols on a cycle ergometer. The exercise protocol will consist of repeated 2-min exercise bouts, separated by 2-min recovery periods in between work bouts in order to allow application of the VitaBreath device. During the 1st min of each recovery period patients will breathe either via the VitaBreath device or adopting the pursed lip breathing technique. During the 2nd min of each recovery period patients will breathe normally. Patients will also score the intensity of their perceived dyspnoea using the Borg 1-10 scale. Cardiac output and stroke volume will be measured non-invasively using a cardio-impedance method (physio-flow) throughout the exercise and recovery periods. Respiratory muscle activation (EMG) and local respiratory muscle oxygen tissue oxygenation (NIRS) will be continuously recorded non-invasively using optodes placed on the skin throughout the exercise and recovery periods. In addition, arterial oxygen saturation will be recorded throughout the exercise and recovery periods using a pulse oximeter.
Sample size estimation
Estimation of sample size within each breathing modality is based on the results of a study comparing use of the VitaBreath device to pursed lip breathing (PLB). Using the mean difference in the recovery of inspiratory capacity compared to the end of exercise (130 ml) between the VitaBreath device and PLB, the SD (110 ml), an alpha significance level of 0.05 (2-sided) and 80% power, a minimum total sample size of 11 patients is calculated to be sufficient to detect significant differences in the magnitude of change in thoracoabdominal wall dynamic hyperinflation between the VitaBreath device and PLB trials. 12 patients will be recruited in order to perform the trials in a balanced ordering sequence.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- VitaBreath device
- Keywords
- Chronic Obstructive Pulmonary Disease, Dynamic Hyperinflation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitaBreath deviceDevice
The VitaBreath (Philips, Respironics) is a portable, handheld, battery powered, non-invasive ventilation device, that has been shown by our group to reduce activity-related shortness of breath in patients with COPD. It delivers 18 cmH2O inspiratory and 8 cmH2O expiratory pressures, but can only be used during recovery periods. In our study patients will perform consecutive bouts of exercise alternated by two minute of recovery in order to allow the use of the VitaBreath device during the first minute of each recovery period.
| Study group | Role | What they receive |
|---|---|---|
| Control pursed lip breathing | Other | Patients will undergo one intermittent exercise protocols on a cycle ergometer. The exercise protocol will consist of repeated 2-min exercise bouts, separated by 2-min recovery periods in between work bouts. During the 1st min of each recovery period patients will breathe adopting the pursed lip breathing technique. During the 2nd min of each recovery period patients will breathe normally. Patients will also score the intensity of their perceived dyspnoea using the Borg 1-10 scale. Cardiac output and stroke volume will be measured non-invasively using a cardio-impedance method (physio-flow) throughout the exercise and recovery periods. Respiratory muscle activation (EMG) and local respiratory muscle oxygen tissue oxygenation (NIRS) will be continuously recorded non-invasively using optodes placed on the skin throughout the exercise and recovery periods. In addition, arterial oxygen saturation will be recorded throughout the exercise and recovery periods using a pulse oximeter. Receives: Device: VitaBreath device |
| pNIV | Experimental | Patients will undergo one intermittent exercise protocols on a cycle ergometer. The exercise protocol will consist of repeated 2-min exercise bouts, separated by 2-min recovery periods in between work bouts. During the 1st min of each recovery period patients will breathe via the VitaBreath device. During the 2nd min of each recovery period patients will breathe normally. Patients will also score the intensity of their perceived dyspnoea using the Borg 1-10 scale. Cardiac output and stroke volume will be measured non-invasively using a cardio-impedance method (physio-flow) throughout the exercise and recovery periods. Respiratory muscle activation (EMG) and local respiratory muscle oxygen tissue oxygenation (NIRS) will be continuously recorded non-invasively using optodes placed on the skin throughout the exercise and recovery periods. In addition, arterial oxygen saturation will be recorded throughout the exercise and recovery periods using a pulse oximeter. Receives: Device: VitaBreath device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The magnitude of change in thoracoabdominal wall dynamic hyperinflation.
Change from baseline in litres of thoracoabdominal wall volume at end of exercise and recovery from exercise from resting breathing.
Measured: The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 1 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial.
Secondary outcomes (4)
Compartmental thoracoabdominal wall volumes (rib cage and abdominal volumes) assessed by OEP.
Change from baseline in litres of compartmental thoracoabdominal wall volume at end of exercise and recovery from exercise from resting breathing.
Measured: The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 2 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial.
Electromyographic activation (expressed as fractions of peak activation and in absolute terms in mV) assessed by surface electromyography
Change from baseline in integrated EMG signal from respiratory muscles at end of exercise and recovery from exercise from resting breathing.
Measured: The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 3 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial.
Respiratory muscle oxygenation requirements recorded from the intercostal and abdominal muscles by near infrared spectroscopy including measurements of: total haemoglobin (TOI), oxygenated haemoglobin (HbO2) and deoxygenated haemoglobin (HHb).
Change from baseline in fractional oxygen saturation of the respiratory muscles at end of exercise and recovery from exercise from resting breathing.
Measured: The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 4 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial.
Cardiac output responses assessed non-invasively by cardio impedance technology
Change from baseline in cardiac output at end of exercise and recovery from exercise from resting breathing.
Measured: The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 5 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Jul 2019
- Primary completion20 Dec 2019
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomised crossover trial. Patients will perform two identical exercise tests and the intervention (VitaBreath) will be compared to control condition (pursed-lip breathing) in the same patients.The order of testing will be determined by simple randomisation (sealedenvelope.com).
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- North Tyneside General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848819
- Sponsor's protocol ID
- 259201
- Status last verified
- Feb 2019
- First submitted
- 13 Feb 2019
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
O'Donnell DE, Revill SM, Webb KA. Dynamic hyperinflation and exercise intolerance in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Sep 1;164(5):770-7. doi: 10.1164/ajrccm.164.5.2012122.
PubMed 11549531Maltais F, Decramer M, Casaburi R, Barreiro E, Burelle Y, Debigare R, Dekhuijzen PN, Franssen F, Gayan-Ramirez G, Gea J, Gosker HR, Gosselink R, Hayot M, Hussain SN, Janssens W, Polkey MI, Roca J, Saey D, Schols AM, Spruit MA, Steiner M, Taivassalo T, Troosters T, Vogiatzis I, Wagner PD; ATS/ERS Ad Hoc Committee on Limb Muscle Dysfunction in COPD. An official American Thoracic Society/European Respiratory Society statement: update on limb muscle dysfunction in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2014 May 1;189(9):e15-62. doi: 10.1164/rccm.201402-0373ST.
PubMed 24787074Vogiatzis I, Zakynthinos S. Factors limiting exercise tolerance in chronic lung diseases. Compr Physiol. 2012 Jul;2(3):1779-817. doi: 10.1002/cphy.c110015.
PubMed 23723024Beauchamp MK, Nonoyama M, Goldstein RS, Hill K, Dolmage TE, Mathur S, Brooks D. Interval versus continuous training in individuals with chronic obstructive pulmonary disease--a systematic review. Thorax. 2010 Feb;65(2):157-64. doi: 10.1136/thx.2009.123000. Epub 2009 Dec 8.
PubMed 19996334Morris NR, Walsh J, Adams L, Alision J. Exercise training in COPD: What is it about intensity? Respirology. 2016 Oct;21(7):1185-92. doi: 10.1111/resp.12864.
PubMed 27623321Puente-Maestu L, Palange P, Casaburi R, Laveneziana P, Maltais F, Neder JA, O'Donnell DE, Onorati P, Porszasz J, Rabinovich R, Rossiter HB, Singh S, Troosters T, Ward S. Use of exercise testing in the evaluation of interventional efficacy: an official ERS statement. Eur Respir J. 2016 Feb;47(2):429-60. doi: 10.1183/13993003.00745-2015. Epub 2016 Jan 21.
PubMed 26797036Sabapathy S, Kingsley RA, Schneider DA, Adams L, Morris NR. Continuous and intermittent exercise responses in individuals with chronic obstructive pulmonary disease. Thorax. 2004 Dec;59(12):1026-31. doi: 10.1136/thx.2004.026617.
PubMed 15563700O'Donnell DE, D'Arsigny C, Webb KA. Effects of hyperoxia on ventilatory limitation during exercise in advanced chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Mar;163(4):892-8. doi: 10.1164/ajrccm.163.4.2007026.
PubMed 11282762Palange P. Lighter than air: heliox breathing improves exercise tolerance in COPD. Eur Respir Rev. 2010 Mar;19(115):1-3. doi: 10.1183/09059180.00000210. No abstract available.
PubMed 20956159Ambrosino N, Cigni P. Non invasive ventilation as an additional tool for exercise training. Multidiscip Respir Med. 2015 Apr 9;10(1):14. doi: 10.1186/s40248-015-0008-1. eCollection 2015.
PubMed 25874110Vogiatzis I, Chynkiamis N, Armstrong M, Lane ND, Hartley T, Gray WK, Bourke SC. Intermittent Use of Portable NIV Increases Exercise Tolerance in COPD: A Randomised, Cross-Over Trial. J Clin Med. 2019 Jan 15;8(1):94. doi: 10.3390/jcm8010094.
PubMed 30650617Vogiatzis I, Georgiadou O, Golemati S, Aliverti A, Kosmas E, Kastanakis E, Geladas N, Koutsoukou A, Nanas S, Zakynthinos S, Roussos C. Patterns of dynamic hyperinflation during exercise and recovery in patients with severe chronic obstructive pulmonary disease. Thorax. 2005 Sep;60(9):723-9. doi: 10.1136/thx.2004.039115. Epub 2005 Jun 17.
PubMed 15964912
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the VitaBreath Device on Chest Wall Dynamic Hyperinflation and Respiratory Muscle Activation During Recovery From Exercise in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03848819
- Acronym / sponsor ID
- 259201
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Dynamic Hyperinflation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- North Tyneside General Hospital
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The VitaBreath (Philips, Respironics) is a portable, handheld, battery powered, non-invasive ventilation device, that has been shown to reduce activity-related shortness of breath in patients with COPD. The VitaBreath device delivers 18 cmH2O inspiratory and 8 cmH2O expiratory pressures, but can only be used during recovery periods.
A previous study (REC: 17/NE/0085) showed that use of the VitaBreath device during the recovery periods interspersing successive exercise bouts enhances exercise tolerance and reduces breathlessness compared to pursed lip breathing in patients with COPD. This was attributed to faster recovery from exercise-induced dynamic hyperinflation, assessed by volitional inspiratory capacity manoeuvres using a spirometer. However, inspiratory capacity manoeuvres are effort dependent, thus limiting the number of repetitions the patient can perform during exercise. In addition, investigation of the direct effect of the application of the VitaBreath device on dynamic hyperinflation was not possible due to the need to employ a spirometer for assessing inspiratory capacity. Optoelectronic plethysmography (OEP) allows continuous non-invasive assessment of end-inspiratory and end-expiratory volumes of the thoracoabdominal wall and its compartments, thereby facilitating assessment of dynamic hyperinflation on a breath-by-breath basis without the necessity to breathe via a spirometer. Unfortunately, OEP technology was not available at the time of our previous study.
The investigators will use OEP to provide accurate breath-by-breath volume measurements during exercise and recovery to evaluate whether the VitaBreath device reduces total and compartmental thoracoabdominal wall volumes compared to the pursed lip breathing technique.
Furthermore, the investigators will investigate the effect of use of the VitaBreath device on respiratory muscle activation and respiratory muscle oxygenation using OEP technology in conjunction with electromyography (EMG) and near inferred spectroscopy (NIRS), respectively to appreciate how the application of the VitaBreath device impacts on the operation and energy demands of the respiratory muscles as compared to control pursed lip breathing.
The investigators hypothesised that the use of the VitaBreath device during the recovery periods interspersing successive exercise bouts will reduce the magnitude of dynamic hyperinflation in a greater extent compared to the pursed lip breathing technique.
Detailed description
Study Design:
This is a randomised crossover trial. Patients will perform two identical exercise tests and the intervention (VitaBreath) will be compared to control condition (pursed-lip breathing) in the same patients. The order of testing will be determined by simple randomisation (sealedenvelope.com).
The purpose of this study is to investigate the effect of the VitaBreath device on inspiratory and expiratory thoracoabdominal wall volumes during exercise in patients with COPD. Use of the VitaBreath device will be compared to normal breathing (pursed lip breathing technique). Patients will primarily be recruited from those who participated in our previous study (REC reference: 17/NE/0085 - IRAS project ID: 221120) at North Tyneside General Hospital and will undergo two exercise tests on a cycle ergometer on the same day using both the VitaBreath device and the pursed-lip breathing technique during recovery from exercise.
Study interventions:
The study will include two visits. During the first visit patients will undergo a clinical assessment, including history, physical examination, ECG and full lung function assessment including spirometry, to ensure that patients are stable. During the second visit patients will perform two intermittent exercise tests lasting 20 minutes each and consisting of 2-min work bouts at 80% of peak work rate (WR peak) as determined in the previous study (REC reference: 17/NE/0085 - IRAS project ID: 221120) with 2-min recovery periods in between work bouts, using either the VitaBreath device or the pursed lip breathing technique during recovery periods. Patients will be given written information explaining the procedure and will provide written informed consent.
Assessment Procedures
Visit 1
Baseline assessment
During the first visit patients will undergo the following baseline assessment: a) medical history and physical examination, b) spirometry and c) resting ECG to assess the resting heart function.
Visit 2
Preparation of the patients
Upon arrival to the laboratory, and prior to any intervention, adhesive skin markers for Opto-Electronic Plethysmography (OEP) recordings (to assess thoracoabdominal wall dynamic hyperinflation), and set of adhesive optodes for portable cardio-impedance recordings (to assess cardiac output), muscle surface electromyography (to assess muscle recruitment patterns) and near inferred spectroscopy (to assess respiratory muscle oxygen requirement) will be attached on the skin. All procedures will be explained in detail prior each trial.
Operational chest wall volumes
At baseline, patients will be instructed after 3-4 regular tidal breaths to make two maximal inspiratory capacity (IC) efforts from End Expiratory Chest Wall (EECW) Volume to Total Chest Wall Capacity (TLCCW) in order to assess chest wall volume at TLC (TLCCW) and Inspiratory Reserve Chest wall Volume (IRVcw) at rest. During exercise and recovery, chest wall kinematics will be measured by OEP as follows: the movement of 89 retro-reflective markers placed front and back over the chest wall from clavicles to pubis will be recorded. Each marker will be tracked by eight video cameras (Smart System BTS, Milan, Italy), four in front of the subject and four behind. Subjects will be grasp handles positioned at the mid sternum level which will lift the arms away from the rib cage so that lateral markers can be visualised. Dedicated software reconstructs the three-dimensional coordinates of the markers in real time by stereophotogrametry and calculates total and compartmental chest wall volume and volume variations using Gauss's theorem. The chest wall is modelled as being composed of two compartments-the rib cage and the abdomen. Vcw is the sum of the rib cage volume (Vrc) and abdominal volume (Vab).
Non-Invasive assessment of respiratory muscle oxygenation
In addition to operational chest wall volumes investigators are going to assess intercostal and abdominal local muscle oxygenation using Near-Infrared Spectroscopy (NIRS). Two NIRS optodes, which will be connected to a NIRO 200 spectrophotometer (Hamamatsu Photonics, Hamamatsu, Japan), will be placed on the skin over the left seventh intercostal space at the midaxillary line and over the upper rectus abdominis respectively, and will be secured using adhesive tape. The left intercostal space will be used to avoid potential blood flow contributions from the liver on the right side of the body.
Respiratory muscle electromyography
Electromyography (EMG) will be used in order assess respiratory muscle activation. Skin will be cleaned and surface electrodes (Delsys Trigno, Delsys, Boston, MA, USA) will be placed as follows: on the surface over the right seventh intercostal space (EMGic), 2 cm lateral to the umbilicus, over the muscle mass of rectus abdominis (EMGra), over the sternocleidomastoid muscle (EMGster), and on the scalene muscle (EMGsca). EMG data will be recorded at 2000Hz and will be filtered at 25-500 Hz during each trial (Spike 2, Cambridge Electronic Design, Cambridge, UK).
Exercise protocol
Patients will undergo two intermittent exercise protocols on a cycle ergometer. The exercise protocol will consist of repeated 2-min exercise bouts, separated by 2-min recovery periods in between work bouts in order to allow application of the VitaBreath device. During the 1st min of each recovery period patients will breathe either via the VitaBreath device or adopting the pursed lip breathing technique. During the 2nd min of each recovery period patients will breathe normally. Patients will also score the intensity of their perceived dyspnoea using the Borg 1-10 scale. Cardiac output and stroke volume will be measured non-invasively using a cardio-impedance method (physio-flow) throughout the exercise and recovery periods. Respiratory muscle activation (EMG) and local respiratory muscle oxygen tissue oxygenation (NIRS) will be continuously recorded non-invasively using optodes placed on the skin throughout the exercise and recovery periods. In addition, arterial oxygen saturation will be recorded throughout the exercise and recovery periods using a pulse oximeter.
Sample size estimation
Estimation of sample size within each breathing modality is based on the results of a study comparing use of the VitaBreath device to pursed lip breathing (PLB). Using the mean difference in the recovery of inspiratory capacity compared to the end of exercise (130 ml) between the VitaBreath device and PLB, the SD (110 ml), an alpha significance level of 0.05 (2-sided) and 80% power, a minimum total sample size of 11 patients is calculated to be sufficient to detect significant differences in the magnitude of change in thoracoabdominal wall dynamic hyperinflation between the VitaBreath device and PLB trials. 12 patients will be recruited in order to perform the trials in a balanced ordering sequence.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomised crossover trial. Patients will perform two identical exercise tests and the intervention (VitaBreath) will be compared to control condition (pursed-lip breathing) in the same patients.The order of testing will be determined by simple randomisation (sealedenvelope.com).
| Arm | Type | Receives |
|---|---|---|
| Control pursed lip breathing | Other | Device: VitaBreath devicePatients will undergo one intermittent exercise protocols on a cycle ergometer. The exercise protocol will consist of repeated 2-min exercise bouts, separated by 2-min recovery periods in between work bouts. During the 1st min of each recovery period patients will breathe adopting the pursed lip breathing technique. During the 2nd min of each recovery period patients will breathe normally. Patients will also score the intensity of their perceived dyspnoea using the Borg 1-10 scale. Cardiac output and stroke volume will be measured non-invasively using a cardio-impedance method (physio-flow) throughout the exercise and recovery periods. Respiratory muscle activation (EMG) and local respiratory muscle oxygen tissue oxygenation (NIRS) will be continuously recorded non-invasively using optodes placed on the skin throughout the exercise and recovery periods. In addition, arterial oxygen saturation will be recorded throughout the exercise and recovery periods using a pulse oximeter. |
| pNIV | Experimental | Device: VitaBreath devicePatients will undergo one intermittent exercise protocols on a cycle ergometer. The exercise protocol will consist of repeated 2-min exercise bouts, separated by 2-min recovery periods in between work bouts. During the 1st min of each recovery period patients will breathe via the VitaBreath device. During the 2nd min of each recovery period patients will breathe normally. Patients will also score the intensity of their perceived dyspnoea using the Borg 1-10 scale. Cardiac output and stroke volume will be measured non-invasively using a cardio-impedance method (physio-flow) throughout the exercise and recovery periods. Respiratory muscle activation (EMG) and local respiratory muscle oxygen tissue oxygenation (NIRS) will be continuously recorded non-invasively using optodes placed on the skin throughout the exercise and recovery periods. In addition, arterial oxygen saturation will be recorded throughout the exercise and recovery periods using a pulse oximeter. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged 40 years or older.
- Current or previous smoking history: 10 or more pack years.
- Spirometry confirmed stable COPD (GOLD stages II-IV) under optimal medical therapy.
- Exhibit substantial exercise-induced dynamic hyperinflation (ΔIC baseline > 0,150 L)
Key exclusion criteria (9 listed)
- Orthopaedic, neurological or other concomitant diseases that significantly impair normal biomechanical movement patterns, as judged by the investigator.
- Moderate or severe COPD exacerbation within 6 weeks.
- Unstable cardiac arrhythmia.
- Unstable ischaemic heart disease, including myocardial infarction within 6 weeks.
- Moderate or severe aortic stenosis or hypertrophic obstructive cardiomyopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VitaBreath deviceThe VitaBreath (Philips, Respironics) is a portable, handheld, battery powered, non-invasive ventilation device, that has been shown by our group to reduce activity-related shortness of breath in patients with COPD. It delivers 18 cmH2O inspiratory and 8 cmH2O expiratory pressures, but can only be used during recovery periods. In our study patients will perform consecutive bouts of exercise alternated by two minute of recovery in order to allow the use of the VitaBreath device during the first minute of each recovery period. | Device | Control pursed lip breathing, pNIV |
Primary outcome
The magnitude of change in thoracoabdominal wall dynamic hyperinflation.
Time frame: The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 1 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial.
Change from baseline in litres of thoracoabdominal wall volume at end of exercise and recovery from exercise from resting breathing.
4 secondary outcomes
Compartmental thoracoabdominal wall volumes (rib cage and abdominal volumes) assessed by OEP.
Time frame: The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 2 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial.
Electromyographic activation (expressed as fractions of peak activation and in absolute terms in mV) assessed by surface electromyography
Time frame: The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 3 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial.
Respiratory muscle oxygenation requirements recorded from the intercostal and abdominal muscles by near infrared spectroscopy including measurements of: total haemoglobin (TOI), oxygenated haemoglobin (HbO2) and deoxygenated haemoglobin (HHb).
Time frame: The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 4 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial.
Cardiac output responses assessed non-invasively by cardio impedance technology
Time frame: The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 5 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Background: PubMed 11549531O'Donnell DE, Revill SM, Webb KA. Dynamic hyperinflation and exercise intolerance in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Sep 1;164(5):770-7. doi: 10.1164/ajrccm.164.5.2012122.
- Background: PubMed 24787074Maltais F, Decramer M, Casaburi R, Barreiro E, Burelle Y, Debigare R, Dekhuijzen PN, Franssen F, Gayan-Ramirez G, Gea J, Gosker HR, Gosselink R, Hayot M, Hussain SN, Janssens W, Polkey MI, Roca J, Saey D, Schols AM, Spruit MA, Steiner M, Taivassalo T, Troosters T, Vogiatzis I, Wagner PD; ATS/ERS Ad Hoc Committee on Limb Muscle Dysfunction in COPD. An official American Thoracic Society/European Respiratory Society statement: update on limb muscle dysfunction in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2014 May 1;189(9):e15-62. doi: 10.1164/rccm.201402-0373ST.
- Background: PubMed 23723024Vogiatzis I, Zakynthinos S. Factors limiting exercise tolerance in chronic lung diseases. Compr Physiol. 2012 Jul;2(3):1779-817. doi: 10.1002/cphy.c110015.
- Background: PubMed 19996334Beauchamp MK, Nonoyama M, Goldstein RS, Hill K, Dolmage TE, Mathur S, Brooks D. Interval versus continuous training in individuals with chronic obstructive pulmonary disease--a systematic review. Thorax. 2010 Feb;65(2):157-64. doi: 10.1136/thx.2009.123000. Epub 2009 Dec 8.
- Background: PubMed 27623321Morris NR, Walsh J, Adams L, Alision J. Exercise training in COPD: What is it about intensity? Respirology. 2016 Oct;21(7):1185-92. doi: 10.1111/resp.12864.
- Background: PubMed 26797036Puente-Maestu L, Palange P, Casaburi R, Laveneziana P, Maltais F, Neder JA, O'Donnell DE, Onorati P, Porszasz J, Rabinovich R, Rossiter HB, Singh S, Troosters T, Ward S. Use of exercise testing in the evaluation of interventional efficacy: an official ERS statement. Eur Respir J. 2016 Feb;47(2):429-60. doi: 10.1183/13993003.00745-2015. Epub 2016 Jan 21.
- Background: PubMed 15563700Sabapathy S, Kingsley RA, Schneider DA, Adams L, Morris NR. Continuous and intermittent exercise responses in individuals with chronic obstructive pulmonary disease. Thorax. 2004 Dec;59(12):1026-31. doi: 10.1136/thx.2004.026617.
- Background: PubMed 11282762O'Donnell DE, D'Arsigny C, Webb KA. Effects of hyperoxia on ventilatory limitation during exercise in advanced chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Mar;163(4):892-8. doi: 10.1164/ajrccm.163.4.2007026.
- Background: PubMed 20956159Palange P. Lighter than air: heliox breathing improves exercise tolerance in COPD. Eur Respir Rev. 2010 Mar;19(115):1-3. doi: 10.1183/09059180.00000210. No abstract available.
- Background: PubMed 25874110Ambrosino N, Cigni P. Non invasive ventilation as an additional tool for exercise training. Multidiscip Respir Med. 2015 Apr 9;10(1):14. doi: 10.1186/s40248-015-0008-1. eCollection 2015.
- Background: PubMed 30650617Vogiatzis I, Chynkiamis N, Armstrong M, Lane ND, Hartley T, Gray WK, Bourke SC. Intermittent Use of Portable NIV Increases Exercise Tolerance in COPD: A Randomised, Cross-Over Trial. J Clin Med. 2019 Jan 15;8(1):94. doi: 10.3390/jcm8010094.
- Background: PubMed 15964912Vogiatzis I, Georgiadou O, Golemati S, Aliverti A, Kosmas E, Kastanakis E, Geladas N, Koutsoukou A, Nanas S, Zakynthinos S, Roussos C. Patterns of dynamic hyperinflation during exercise and recovery in patients with severe chronic obstructive pulmonary disease. Thorax. 2005 Sep;60(9):723-9. doi: 10.1136/thx.2004.039115. Epub 2005 Jun 17.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VitaBreath device in people with Chronic Obstructive Pulmonary Disease, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The magnitude of change in thoracoabdominal wall dynamic hyperinflation. (time frame: The intervention will be performed in one visit. During the visit patients will perform 2 trials lasting for 20 minutes each. The outcome 1 will be assessed at rest, at the 20th minute of cycling and 5 minutes post cycling at each trial.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03848819, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.