COPDNCT02860273
High Flow Nasal Cannula and Exercise Testing in Chronic Obstructive Pulmonary Disease (COPD)
A study testing High Flow Nasal Cannula Oxygen and Treadmill in people with COPD, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
In this study the investigators will determine whether the use of High Flow Nasal Cannula Oxygen during test enhances exercise performance in COPD patients on a treadmill. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- High Flow Nasal Cannula Oxygen and Treadmill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteArgentina
- Study dates
- Apr 2016to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically stable defined as four weeks without exacerbation.
- Signed Informed consent
Who cannot join
- Long term oxygen therapy (LTOT) or oxygen needs during exercise
- Any neuromuscular or cardiovascular condition that limits test performance
- Refusal to participate
- Contraindication for exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Capacity Testing in COPD Patients With High Flow Nasal Cannula
In this study the investigators will determine whether the use of High Flow Nasal Cannula Oxygen during test enhances exercise performance in COPD patients on a treadmill.
Read the detailed description
Design: interventional, crossover, randomized.
The main goal of this study is to compare the maximum speed reached in an Incremental Load Treadmill Test (ILTT) and max time tolerated in a Constant Treadmill Load Test (CTLT) while using High Flow Nasal Cannula Oxygen (HFNCO).
Patients will be evaluated through two different kinds of tests: Incremental Load Treadmill Test (ILTT) and Constant Treadmill Load Test (CTLT). Each test will be conducted two times, once using High Flow Nasal Cannula Oxygen and the other breathing room air.
In total, each patient will be evaluated four times on four different visits. The testing order will be randomized through STATA.
The following variables will be measured before, during and after each test:
Max speed reached in an Incremental load test: Km/h Max time tolerate in a Constant Load Test: in seconds Oxygen saturation: % Dyspnea: Modified Borg scale (0-10) Cardiac rate: beats per minute Respiratory rate: breaths per minute Blood pressure: mmHg Lower limbs fatigue: modified Borg scale (0-10) Global comfort according to the device used: visual analogue scale (VAS) 0-10
- Conditions
- COPD
- Being tested
- High Flow Nasal Cannula Oxygen, Treadmill
- Keywords
- Pulmonary Rehabilitation, COPD, High Flow Nasal Cannula, HFNC, Aerobic capacity
- 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.
High Flow Nasal Cannula OxygenDevice
Also called HFNCO
Exercise capacity testing according to High Flow Nasal Cannula Oxygen at 21% in COPD patients involved in a Pulmonary Rehabilitation program.
TreadmillDevice
Exercise capacity testing in COPD patients involved in a Pulmonary Rehabilitation Program.
| Study group | Role | What they receive |
|---|---|---|
| High Flow Nasal Cannula Oxygen | Experimental | 1. Incremental Load Treadmill Test (ILTT) using HFNCO at 21%
2. Constant Treadmill Load Test (CTLT) using HFNCO at 21% Receives: Device: High Flow Nasal Cannula Oxygen |
| Control Group | Other | 1. Incremental Load Treadmill Test (ILTT) at Room Air
2. Constant Treadmill Load Test (CTLT) at Room Air Receives: Device: Treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Exercise capacity - Maximun Walking Time Tolerated
Difference in Maximun Walking time tolerated in a Constant Treadmill Load Test (CTLT) in seconds between HFNCO and Room air
Measured: Baseline and 48 hs after baseline
Secondary outcomes (8)
Difference in Dyspnea
Difference in dyspnea using Modified Borg Scale (0 - 10 points) between HFNCO and Room air
Measured: Baseline and 48 hs after baseline
Difference in Cardiac Rate
Difference in Cardiac Rate (beats per minute) using a pulse oximetry between HFNCO and Room air
Measured: Baseline and 48 hs after baseline
Difference in Oxygen Saturation
Difference in Oxygen Saturation using a pulse oximetry (SpO2) between HFNCO and Room air
Measured: Baseline and 48 hs after baseline
Difference in Global Comfort
Difference in global comfort according to the device used with visual analogue scale (VAS) 0-10 between HFNCO and Room air
Measured: Baseline and 48 hs after baseline
Difference in Lower Limbs Fatigue
Difference in Lower limbs fatigue using modified Borg scale (0-10) between HFNCO and Room air
Measured: Baseline and 48 hs after baseline
Difference in Respiratory Rate
Difference in Respiratory rate in breaths per minute between HFNCO and Room air
Measured: Baseline and 48 hs after baseline
Difference in Blood Pressure
Difference in of Blood pressure in mmHg between HFNCO and Room air
Measured: Baseline and 48 hs after baseline
Difference in Exercise capacity - Maximun Walking Speed Reached
Difference in Maximun walking speed in km/h reached in an Incremental load treadmill test (ILTT) between HFNCO and Room air
Measured: Baseline and 48 hs after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolás NR Roux, PT-RT, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860273
- Sponsor's protocol ID
- 2728
- Status last verified
- May 2018
- First submitted
- 29 Mar 2016
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rabinovich RA, Vilaro J. Structural and functional changes of peripheral muscles in chronic obstructive pulmonary disease patients. Curr Opin Pulm Med. 2010 Mar;16(2):123-33. doi: 10.1097/MCP.0b013e328336438d.
PubMed 20071991Maltais 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 24787074Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.
PubMed 24127811Guell Rous MR, Diaz Lobato S, Rodriguez Trigo G, Morante Velez F, San Miguel M, Cejudo P, Ortega Ruiz F, Munoz A, Galdiz Iturri JB, Garcia A, Servera E; Sociedad Espanola de Neumologia y Cirugia Toracica (SEPAR). Pulmonary rehabilitation. Sociedad Espanola de Neumologia y Cirugia Toracica (SEPAR). Arch Bronconeumol. 2014 Aug;50(8):332-44. doi: 10.1016/j.arbres.2014.02.014. Epub 2014 May 17. English, Spanish.
PubMed 24845559Bolton CE, Blakey JD, Morgan MD; BTS Pulmonary Rehabilitation Guideline Development Group for the Standards of Care Committee for the BTS. The British Thoracic Society guideline on pulmonary rehabilitation in adults: your opinion is noted. Thorax. 2014 Apr;69(4):388-9. doi: 10.1136/thoraxjnl-2013-204754. Epub 2014 Jan 15. No abstract available.
PubMed 24430178Sivori M, Almeida M, Benzo R, Boim C, Brassesco M, Callejas O, Capparelli I, Conti E, Diaz M, Draghi J, Franco J, Gando S, Giuliano G, Guida R, Jolly E, Pessolano F, Rabinovich R, Ratto P, Rhodius E, Saadia M, Salvado A, Sobrino E, Victorio C. [New argentine consensus of respiratory rehabilitation 2008]. Medicina (B Aires). 2008;68(4):325-44. Spanish.
PubMed 18786894Patessio A, Carone M, Ioli F, Donner CF. Ventilatory and metabolic changes as a result of exercise training in COPD patients. Chest. 1992 May;101(5 Suppl):274S-278S. doi: 10.1378/chest.101.5_supplement.274s.
PubMed 1576849O'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 11282762Nonoyama ML, Brooks D, Lacasse Y, Guyatt GH, Goldstein RS. Oxygen therapy during exercise training in chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD005372. doi: 10.1002/14651858.CD005372.pub2.
PubMed 17443585Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
PubMed 25981908Dysart K, Miller TL, Wolfson MR, Shaffer TH. Research in high flow therapy: mechanisms of action. Respir Med. 2009 Oct;103(10):1400-5. doi: 10.1016/j.rmed.2009.04.007. Epub 2009 May 21.
PubMed 19467849Spoletini G, Alotaibi M, Blasi F, Hill NS. Heated Humidified High-Flow Nasal Oxygen in Adults: Mechanisms of Action and Clinical Implications. Chest. 2015 Jul;148(1):253-261. doi: 10.1378/chest.14-2871.
PubMed 25742321Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.
PubMed 25866645Hardinge M, Suntharalingam J, Wilkinson T; British Thoracic Society. Guideline update: The British Thoracic Society Guidelines on home oxygen use in adults. Thorax. 2015 Jun;70(6):589-91. doi: 10.1136/thoraxjnl-2015-206918. Epub 2015 Apr 27.
PubMed 25918120Cooper CB, Abrazado M, Legg D, Kesten S. Development and implementation of treadmill exercise testing protocols in COPD. Int J Chron Obstruct Pulmon Dis. 2010 Oct 12;5:375-85. doi: 10.2147/copd.s11153.
PubMed 21103404
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Capacity Testing in COPD Patients With High Flow Nasal Cannula
- ClinicalTrials.gov ID
- NCT02860273
- Acronym / sponsor ID
- 2728
- Conditions
- COPD
- Keywords
- Pulmonary Rehabilitation, COPD, High Flow Nasal Cannula, HFNC, Aerobic capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 9 Aug 2016 (estimated)
- 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.
In this study the investigators will determine whether the use of High Flow Nasal Cannula Oxygen during test enhances exercise performance in COPD patients on a treadmill.
Detailed description
Design: interventional, crossover, randomized.
The main goal of this study is to compare the maximum speed reached in an Incremental Load Treadmill Test (ILTT) and max time tolerated in a Constant Treadmill Load Test (CTLT) while using High Flow Nasal Cannula Oxygen (HFNCO).
Patients will be evaluated through two different kinds of tests: Incremental Load Treadmill Test (ILTT) and Constant Treadmill Load Test (CTLT). Each test will be conducted two times, once using High Flow Nasal Cannula Oxygen and the other breathing room air.
In total, each patient will be evaluated four times on four different visits. The testing order will be randomized through STATA.
The following variables will be measured before, during and after each test:
Max speed reached in an Incremental load test: Km/h Max time tolerate in a Constant Load Test: in seconds Oxygen saturation: % Dyspnea: Modified Borg scale (0-10) Cardiac rate: beats per minute Respiratory rate: breaths per minute Blood pressure: mmHg Lower limbs fatigue: modified Borg scale (0-10) Global comfort according to the device used: visual analogue scale (VAS) 0-10
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Cannula Oxygen | Experimental | Device: High Flow Nasal Cannula Oxygen1. Incremental Load Treadmill Test (ILTT) using HFNCO at 21% 2. Constant Treadmill Load Test (CTLT) using HFNCO at 21% |
| Control Group | Other | Device: Treadmill1. Incremental Load Treadmill Test (ILTT) at Room Air 2. Constant Treadmill Load Test (CTLT) at Room Air |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically stable defined as four weeks without exacerbation.
- Signed Informed consent
Key exclusion criteria (4 listed)
- Long term oxygen therapy (LTOT) or oxygen needs during exercise
- Any neuromuscular or cardiovascular condition that limits test performance
- Refusal to participate
- Contraindication for exercise
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 |
|---|---|---|
| High Flow Nasal Cannula OxygenAlso: HFNCOExercise capacity testing according to High Flow Nasal Cannula Oxygen at 21% in COPD patients involved in a Pulmonary Rehabilitation program. | Device | High Flow Nasal Cannula Oxygen |
| TreadmillExercise capacity testing in COPD patients involved in a Pulmonary Rehabilitation Program. | Device | Control Group |
Primary outcome
Difference in Exercise capacity - Maximun Walking Time Tolerated
Time frame: Baseline and 48 hs after baseline
Difference in Maximun Walking time tolerated in a Constant Treadmill Load Test (CTLT) in seconds between HFNCO and Room air
8 secondary outcomes
Difference in Dyspnea
Time frame: Baseline and 48 hs after baseline
Difference in Cardiac Rate
Time frame: Baseline and 48 hs after baseline
Difference in Oxygen Saturation
Time frame: Baseline and 48 hs after baseline
Difference in Global Comfort
Time frame: Baseline and 48 hs after baseline
Difference in Lower Limbs Fatigue
Time frame: Baseline and 48 hs after baseline
Difference in Respiratory Rate
Time frame: Baseline and 48 hs after baseline
Difference in Blood Pressure
Time frame: Baseline and 48 hs after baseline
Difference in Exercise capacity - Maximun Walking Speed Reached
Time frame: Baseline and 48 hs after baseline
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 22 May 2023.
- Results publication: PubMed 20071991Rabinovich RA, Vilaro J. Structural and functional changes of peripheral muscles in chronic obstructive pulmonary disease patients. Curr Opin Pulm Med. 2010 Mar;16(2):123-33. doi: 10.1097/MCP.0b013e328336438d.
- Results publication: 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.
- Results publication: PubMed 24127811Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.
- Results publication: PubMed 24845559Guell Rous MR, Diaz Lobato S, Rodriguez Trigo G, Morante Velez F, San Miguel M, Cejudo P, Ortega Ruiz F, Munoz A, Galdiz Iturri JB, Garcia A, Servera E; Sociedad Espanola de Neumologia y Cirugia Toracica (SEPAR). Pulmonary rehabilitation. Sociedad Espanola de Neumologia y Cirugia Toracica (SEPAR). Arch Bronconeumol. 2014 Aug;50(8):332-44. doi: 10.1016/j.arbres.2014.02.014. Epub 2014 May 17. English, Spanish.
- Results publication: PubMed 24430178Bolton CE, Blakey JD, Morgan MD; BTS Pulmonary Rehabilitation Guideline Development Group for the Standards of Care Committee for the BTS. The British Thoracic Society guideline on pulmonary rehabilitation in adults: your opinion is noted. Thorax. 2014 Apr;69(4):388-9. doi: 10.1136/thoraxjnl-2013-204754. Epub 2014 Jan 15. No abstract available.
- Results publication: PubMed 18786894Sivori M, Almeida M, Benzo R, Boim C, Brassesco M, Callejas O, Capparelli I, Conti E, Diaz M, Draghi J, Franco J, Gando S, Giuliano G, Guida R, Jolly E, Pessolano F, Rabinovich R, Ratto P, Rhodius E, Saadia M, Salvado A, Sobrino E, Victorio C. [New argentine consensus of respiratory rehabilitation 2008]. Medicina (B Aires). 2008;68(4):325-44. Spanish.
- Results publication: PubMed 1576849Patessio A, Carone M, Ioli F, Donner CF. Ventilatory and metabolic changes as a result of exercise training in COPD patients. Chest. 1992 May;101(5 Suppl):274S-278S. doi: 10.1378/chest.101.5_supplement.274s.
- Results publication: 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.
- Results publication: PubMed 17443585Nonoyama ML, Brooks D, Lacasse Y, Guyatt GH, Goldstein RS. Oxygen therapy during exercise training in chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD005372. doi: 10.1002/14651858.CD005372.pub2.
- Results publication: PubMed 25981908Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
- Results publication: PubMed 19467849Dysart K, Miller TL, Wolfson MR, Shaffer TH. Research in high flow therapy: mechanisms of action. Respir Med. 2009 Oct;103(10):1400-5. doi: 10.1016/j.rmed.2009.04.007. Epub 2009 May 21.
- Results publication: PubMed 25742321Spoletini G, Alotaibi M, Blasi F, Hill NS. Heated Humidified High-Flow Nasal Oxygen in Adults: Mechanisms of Action and Clinical Implications. Chest. 2015 Jul;148(1):253-261. doi: 10.1378/chest.14-2871.
- Global initiative for Chronic Obstructive Lung Disease. Update 2016Link provided by the sponsor.
- 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.
Nicolás NR Roux, PT-RT principal investigator
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal Cannula Oxygen and Treadmill in people with COPD, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 2 inclusion and 4 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 22 May 2023. 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 Argentina. 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?
Difference in Exercise capacity - Maximun Walking Time Tolerated (time frame: Baseline and 48 hs after baseline). 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 NCT02860273, which also lists 25 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 22 May 2023.