Chronic Obstructive Pulmonary DiseaseNCT03068026
Influence of the VitaBreath on Exercise Tolerance in COPD
A study testing VitaBreath and Pursed Lip Breathing technique in people with Chronic Obstructive Pulmonary Disease, run by North Tyneside General Hospital at 1 site in United Kingdom.
Trial summary
People with COPD have more air in their lungs than other people (this problem with high lung volumes is called "hyperinflation"). Unfortunately this is unhelpful as breathing at higher lung volumes requires more effort and contributes to breathlessness. When anyone exercises, they breathe more quickly. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- VitaBreath and Pursed Lip Breathing technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jun 2017to 30 Sep 2018
- 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 to 80 years
- 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 > 0.15 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.
Show all 9Show fewer
- Uncontrolled hypotension (SBP<85mmHg).
- Uncontrolled diabetes.
- Intolerance of the VitaBreath device.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
North Tyneside General Hospital
Newcastle upon Tyne, Northumberland, NE29 8NH
About this study
Official title: Influence of the VitaBreath Device on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease
People with COPD have more air in their lungs than other people (this problem with high lung volumes is called "hyperinflation"). Unfortunately this is unhelpful as breathing at higher lung volumes requires more effort and contributes to breathlessness. When anyone exercises, they breathe more quickly. People with COPD have narrowed airways, which makes breathing out difficult. When they breathe more quickly they may not be able to breathe out fully before they need to take the next breath in. This means that the volume of air in their lungs tends to increase further during exercise, which makes breathing even more difficult. This problem is called "dynamic hyperinflation".
Pulmonary rehabilitation is one of the most helpful interventions for people with COPD and most of the benefit gained is from exercise. Anything that helps people increase the amount of exercise they can perform should lead to further improvements.
Non-invasive positive pressure ventilation is a method of supporting a person's normal breathing. The ventilator delivers a flow of air at low pressure as you breathe out, which helps patients to breathe out more completely. The device also detects when patients start to breathe in and delivers a stronger flow of air at a higher pressure, helping them to take a deeper breath in. Previous research studies have shown that when people with COPD use non-invasive ventilation during exercise they are able to exercise for longer and are less breathless. The purpose of this study is to assess whether a new portable non-invasive ventilation device, called the VitaBreath, helps people with COPD recover from breathlessness during the exercise breaks more quickly (by reducing "dynamic hyperinflation", described above) and to exercise for longer overall. The VitaBreath device is small and light, weighing 0.5 kilograms (just over one pound). It is handheld and battery powered.
Read the detailed description
In patients with chronic obstructive pulmonary disease (COPD) dynamic hyperinflation (DH) and the concurrent mechanical constraints on tidal volume expansion during exercise increase work of breathing and perceived respiratory discomfort, limiting endurance. An additional consequence of DH and the concomitant high mean intrathoracic pressure swings, cardiac performance and, hence, supply of oxygenated blood to the malfunctioning peripheral muscles is further compromised. This contributes to perceived leg discomfort and exercise intolerance.
Bronchodilator therapy is associated with a reduction in operating lung volumes, leading to improvements in perceived breathlessness and exercise tolerance. Heliox (helium and oxygen) is less dense and generates less airway resistance than air. Heliox breathing has been shown to improve exercise tolerance in COPD. A recent study demonstrated that compared to room air, breathing heliox during constant-load exercise (CLE) (continuous) increased inspiratory capacity (IC), and lessened DH, breathlessness and leg discomfort at isotime and at the point of exercise limitation. In addition, heliox breathing increased stroke volume, cardiac output and hence locomotor muscle oxygen delivery. However, the main drawback of heliox supplementation is the high cost, especially when it is used for long periods of time. Previous studies using inspiratory pressure support have shown improvements in dyspnoea and exercise capacity by reducing the work of breathing, as well as improved central hemodynamic responses and peripheral muscle oxygenation.
In comparison to traditional noninvasive ventilators, the Vitabreath device, which provides positive inspiratory pressure, is compact, light and inexpensive. Ease of operation, portability and battery life support use to aid relief of breathlessness, including away from the patient's home. This should facilitate maintenance of, and improvement in, activity. Vitabreath may also prove to be a useful tool to increasing exercise tolerance and the intensity of training, and hence the magnitude of physiological adaptations by mitigating DH during rehabilitative exercise training.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- VitaBreath, Pursed Lip Breathing technique
- Keywords
- Chronic Obstructive Pulmonary Disease, Non-invasive ventilation
- 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.
VitaBreathDevice
The VitaBreath devise will be applied during the 1st minute of each resting period between exercise bouts and during the 1st minute of recovery.
Pursed Lip Breathing techniqueOther
Pursed Lip Breathing technique will be applied during the 1st minute of each resting period between exercise bouts and during the 1st minute of recovery.
| Study group | Role | What they receive |
|---|---|---|
| Continuous exercise | Experimental | Patients will undergo a constant load exercise protocol with gas exchange analysis on a cycle ergometer. The exercise protocol will be consisted of repeated 6-min exercise bouts, separated by 2-min rest periods in between work bouts in order to allow application of the VitaBreath device. During the 1st min of each resting period participants will breathe either via the VitaBreath device or normally adopting the pursed lip breathing technique. During the 2nd min of each resting period participants will breathe normally and perform an IC maneuver to assess the magnitude of dynamic hyperinflation. Receives: Device: VitaBreath; Other: Pursed Lip Breathing technique |
| Interval exercise | Experimental | Patients will undergo an interval exercise protocol with gas exchange analysis on a cycle ergometer. The exercise protocol will consist of repeated 2-min exercise bouts, separated by 2-min resting periods in between work bouts in order to allow application of the VitaBreath device. During the 1st min of each resting period participants will breathe either via the VitaBreath device or normally adopting the pursed lip breathing technique. During the 2nd min of each rest period participants will breathe normally and perform an IC maneuver, to assess the magnitude of dynamic hyperinflation. Receives: Device: VitaBreath; Other: Pursed Lip Breathing technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise tolerance (total exercise time)
The primary outcome is exercise tolerance (total exercise time) during continuous and interval exercise.
Measured: 12 months
Secondary outcomes (2)
Symptoms
Breathlessness (assessed by Borg 1-10 scale)
Measured: 12 months
Dynamic hyperinflation
Inspiratory capacity (Litres)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start6 Jun 2017
- Primary completion18 Jun 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized crossover trial. The two exercise modalities will be separately assessed in different groups of patients, but within each group the intervention (VitaBreath) will be compared to control (pursed-lip breathing).
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Tyneside General Hospital
- Sponsor type
- Other government
- Collaborators
- Northumbria University
- Responsible party
- Principal investigator, Ioannis Vogiatzis, Northumbria University
- Investigators
- Ioannis Vogiatzis, Ph.D., Principal investigator, Northumbria University of Newcastle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068026
- Sponsor's protocol ID
- HRC-GRA-17030-VBREATH-SH
- Status last verified
- Mar 2021
- First submitted
- 22 Feb 2017
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vogiatzis 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 23723024O'Donnell DE, Lam M, Webb KA. Spirometric correlates of improvement in exercise performance after anticholinergic therapy in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1999 Aug;160(2):542-9. doi: 10.1164/ajrccm.160.2.9901038.
PubMed 10430726Louvaris Z, Vogiatzis I, Aliverti A, Habazettl H, Wagner H, Wagner P, Zakynthinos S. Blood flow does not redistribute from respiratory to leg muscles during exercise breathing heliox or oxygen in COPD. J Appl Physiol (1985). 2014 Aug 1;117(3):267-76. doi: 10.1152/japplphysiol.00490.2014. Epub 2014 Jun 5.
PubMed 24903919O'Donnell DE, Sanii R, Younes M. Improvement in exercise endurance in patients with chronic airflow limitation using continuous positive airway pressure. Am Rev Respir Dis. 1988 Dec;138(6):1510-4. doi: 10.1164/ajrccm/138.6.1510.
PubMed 3059897Keilty SE, Ponte J, Fleming TA, Moxham J. Effect of inspiratory pressure support on exercise tolerance and breathlessness in patients with severe stable chronic obstructive pulmonary disease. Thorax. 1994 Oct;49(10):990-4. doi: 10.1136/thx.49.10.990.
PubMed 7974316Bianchi L, Foglio K, Pagani M, Vitacca M, Rossi A, Ambrosino N. Effects of proportional assist ventilation on exercise tolerance in COPD patients with chronic hypercapnia. Eur Respir J. 1998 Feb;11(2):422-7. doi: 10.1183/09031936.98.11020422.
PubMed 9551748Wysocki M, Meshaka P, Richard JC, Similowski T. Proportional-assist ventilation compared with pressure-support ventilation during exercise in volunteers with external thoracic restriction. Crit Care Med. 2004 Feb;32(2):409-14. doi: 10.1097/01.CCM.0000108869.12426.51.
PubMed 14758156van 't Hul A, Gosselink R, Hollander P, Postmus P, Kwakkel G. Acute effects of inspiratory pressure support during exercise in patients with COPD. Eur Respir J. 2004 Jan;23(1):34-40. doi: 10.1183/09031936.03.00016903.
PubMed 14738228Rodrigues MK, Oliveira MF, Soares A, Treptow E, Neder JA. Additive effects of non-invasive ventilation to hyperoxia on cerebral oxygenation in COPD patients with exercise-related O2 desaturation. Clin Physiol Funct Imaging. 2013 Jul;33(4):274-81. doi: 10.1111/cpf.12024. Epub 2013 Jan 21.
PubMed 23692616Ambrosino 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 25874110
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the VitaBreath Device on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03068026
- Acronym / sponsor ID
- HRC-GRA-17030-VBREATH-SH
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Non-invasive ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- North Tyneside General HospitalOther government
- Collaborators
- Northumbria University
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 18 Jun 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 1 Mar 2017 (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.
People with COPD have more air in their lungs than other people (this problem with high lung volumes is called "hyperinflation"). Unfortunately this is unhelpful as breathing at higher lung volumes requires more effort and contributes to breathlessness. When anyone exercises, they breathe more quickly. People with COPD have narrowed airways, which makes breathing out difficult. When they breathe more quickly they may not be able to breathe out fully before they need to take the next breath in. This means that the volume of air in their lungs tends to increase further during exercise, which makes breathing even more difficult. This problem is called "dynamic hyperinflation".
Pulmonary rehabilitation is one of the most helpful interventions for people with COPD and most of the benefit gained is from exercise. Anything that helps people increase the amount of exercise they can perform should lead to further improvements.
Non-invasive positive pressure ventilation is a method of supporting a person's normal breathing. The ventilator delivers a flow of air at low pressure as you breathe out, which helps patients to breathe out more completely. The device also detects when patients start to breathe in and delivers a stronger flow of air at a higher pressure, helping them to take a deeper breath in. Previous research studies have shown that when people with COPD use non-invasive ventilation during exercise they are able to exercise for longer and are less breathless. The purpose of this study is to assess whether a new portable non-invasive ventilation device, called the VitaBreath, helps people with COPD recover from breathlessness during the exercise breaks more quickly (by reducing "dynamic hyperinflation", described above) and to exercise for longer overall. The VitaBreath device is small and light, weighing 0.5 kilograms (just over one pound). It is handheld and battery powered.
Detailed description
In patients with chronic obstructive pulmonary disease (COPD) dynamic hyperinflation (DH) and the concurrent mechanical constraints on tidal volume expansion during exercise increase work of breathing and perceived respiratory discomfort, limiting endurance. An additional consequence of DH and the concomitant high mean intrathoracic pressure swings, cardiac performance and, hence, supply of oxygenated blood to the malfunctioning peripheral muscles is further compromised. This contributes to perceived leg discomfort and exercise intolerance.
Bronchodilator therapy is associated with a reduction in operating lung volumes, leading to improvements in perceived breathlessness and exercise tolerance. Heliox (helium and oxygen) is less dense and generates less airway resistance than air. Heliox breathing has been shown to improve exercise tolerance in COPD. A recent study demonstrated that compared to room air, breathing heliox during constant-load exercise (CLE) (continuous) increased inspiratory capacity (IC), and lessened DH, breathlessness and leg discomfort at isotime and at the point of exercise limitation. In addition, heliox breathing increased stroke volume, cardiac output and hence locomotor muscle oxygen delivery. However, the main drawback of heliox supplementation is the high cost, especially when it is used for long periods of time. Previous studies using inspiratory pressure support have shown improvements in dyspnoea and exercise capacity by reducing the work of breathing, as well as improved central hemodynamic responses and peripheral muscle oxygenation.
In comparison to traditional noninvasive ventilators, the Vitabreath device, which provides positive inspiratory pressure, is compact, light and inexpensive. Ease of operation, portability and battery life support use to aid relief of breathlessness, including away from the patient's home. This should facilitate maintenance of, and improvement in, activity. Vitabreath may also prove to be a useful tool to increasing exercise tolerance and the intensity of training, and hence the magnitude of physiological adaptations by mitigating DH during rehabilitative exercise training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized crossover trial. The two exercise modalities will be separately assessed in different groups of patients, but within each group the intervention (VitaBreath) will be compared to control (pursed-lip breathing).
| Arm | Type | Receives |
|---|---|---|
| Continuous exercise | Experimental | Device: VitaBreath, Other: Pursed Lip Breathing techniquePatients will undergo a constant load exercise protocol with gas exchange analysis on a cycle ergometer. The exercise protocol will be consisted of repeated 6-min exercise bouts, separated by 2-min rest periods in between work bouts in order to allow application of the VitaBreath device. During the 1st min of each resting period participants will breathe either via the VitaBreath device or normally adopting the pursed lip breathing technique. During the 2nd min of each resting period participants will breathe normally and perform an IC maneuver to assess the magnitude of dynamic hyperinflation. |
| Interval exercise | Experimental | Device: VitaBreath, Other: Pursed Lip Breathing techniquePatients will undergo an interval exercise protocol with gas exchange analysis on a cycle ergometer. The exercise protocol will consist of repeated 2-min exercise bouts, separated by 2-min resting periods in between work bouts in order to allow application of the VitaBreath device. During the 1st min of each resting period participants will breathe either via the VitaBreath device or normally adopting the pursed lip breathing technique. During the 2nd min of each rest period participants will breathe normally and perform an IC maneuver, to assess the magnitude of dynamic hyperinflation. |
Who may qualify
- Ages
- 40 to 80 years
- 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 > 0.15 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 |
|---|---|---|
| VitaBreathThe VitaBreath devise will be applied during the 1st minute of each resting period between exercise bouts and during the 1st minute of recovery. | Device | Continuous exercise, Interval exercise |
| Pursed Lip Breathing techniquePursed Lip Breathing technique will be applied during the 1st minute of each resting period between exercise bouts and during the 1st minute of recovery. | Other | Continuous exercise, Interval exercise |
Primary outcome
Exercise tolerance (total exercise time)
Time frame: 12 months
The primary outcome is exercise tolerance (total exercise time) during continuous and interval exercise.
2 secondary outcomes
Symptoms
Time frame: 12 months
Dynamic hyperinflation
Time frame: 12 months
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 5 Mar 2021.
- 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 10430726O'Donnell DE, Lam M, Webb KA. Spirometric correlates of improvement in exercise performance after anticholinergic therapy in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1999 Aug;160(2):542-9. doi: 10.1164/ajrccm.160.2.9901038.
- Background: PubMed 24903919Louvaris Z, Vogiatzis I, Aliverti A, Habazettl H, Wagner H, Wagner P, Zakynthinos S. Blood flow does not redistribute from respiratory to leg muscles during exercise breathing heliox or oxygen in COPD. J Appl Physiol (1985). 2014 Aug 1;117(3):267-76. doi: 10.1152/japplphysiol.00490.2014. Epub 2014 Jun 5.
- Background: PubMed 3059897O'Donnell DE, Sanii R, Younes M. Improvement in exercise endurance in patients with chronic airflow limitation using continuous positive airway pressure. Am Rev Respir Dis. 1988 Dec;138(6):1510-4. doi: 10.1164/ajrccm/138.6.1510.
- Background: PubMed 7974316Keilty SE, Ponte J, Fleming TA, Moxham J. Effect of inspiratory pressure support on exercise tolerance and breathlessness in patients with severe stable chronic obstructive pulmonary disease. Thorax. 1994 Oct;49(10):990-4. doi: 10.1136/thx.49.10.990.
- Background: PubMed 9551748Bianchi L, Foglio K, Pagani M, Vitacca M, Rossi A, Ambrosino N. Effects of proportional assist ventilation on exercise tolerance in COPD patients with chronic hypercapnia. Eur Respir J. 1998 Feb;11(2):422-7. doi: 10.1183/09031936.98.11020422.
- Background: PubMed 14758156Wysocki M, Meshaka P, Richard JC, Similowski T. Proportional-assist ventilation compared with pressure-support ventilation during exercise in volunteers with external thoracic restriction. Crit Care Med. 2004 Feb;32(2):409-14. doi: 10.1097/01.CCM.0000108869.12426.51.
- Background: PubMed 14738228van 't Hul A, Gosselink R, Hollander P, Postmus P, Kwakkel G. Acute effects of inspiratory pressure support during exercise in patients with COPD. Eur Respir J. 2004 Jan;23(1):34-40. doi: 10.1183/09031936.03.00016903.
- Background: PubMed 23692616Rodrigues MK, Oliveira MF, Soares A, Treptow E, Neder JA. Additive effects of non-invasive ventilation to hyperoxia on cerebral oxygenation in COPD patients with exercise-related O2 desaturation. Clin Physiol Funct Imaging. 2013 Jul;33(4):274-81. doi: 10.1111/cpf.12024. Epub 2013 Jan 21.
- 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.
- Individual participant dataSharing planned: No
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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.
Ioannis Vogiatzis, Ph.D. principal investigator
Northumbria University of Newcastle
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 and Pursed Lip Breathing technique in people with Chronic Obstructive Pulmonary Disease, run by North Tyneside General Hospital 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 5 Mar 2021. 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?
Exercise tolerance (total exercise time) (time frame: 12 months). 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 NCT03068026, which also lists 10 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 5 Mar 2021.