COPDHFONCT03322787
Effect of Exercise Training Under HFO Device on Endurance Tolerance in Patients With COPD and CRF: a Randomized Controlled Study.
A study testing HFO in people with COPD, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
Current literature clearly shows the benefit of pulmonary rehabilitation in symptomatic COPD (Trooster,2005). However, these patients are frequently unable to sustain a work-load sufficiently high to obtain a full benefit on exercise tolerance (Trooster,2005). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- HFO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteItaly
- Study dates
- 6 Nov 2017to 31 Mar 2019
- 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
- COPD and CRF diagnosis under LTOT,
- clinical stability (pH > 7.35 and < 7.46, no change in respiratory drugs therapy during the last seven days)
Who cannot join
- orthopedic or neurological disease,
- cognitive impairment (Mini Mental State Examination < 22)
- anamnestic history of ischemic heart disease or heart failure, COPD+ fibrosis and COPD+ OSAS.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Exercise Training Under High Flow Oxygen (HFO) Device on Endurance Tolerance in Patients With COPD and Chronic Respiratory Failure: a Randomized Controlled Study.
Current literature clearly shows the benefit of pulmonary rehabilitation in symptomatic COPD (Trooster,2005). However, these patients are frequently unable to sustain a work-load sufficiently high to obtain a full benefit on exercise tolerance (Trooster,2005). Especially in patients with Chronic Respiratory Failure (CRF), the development of hypoxia (O'Donnel,2001) and the increase of dead space (Elbehairy,2015) during effort explain the out-of-proportion increase in ventilation leading to an early achievement of the ventilatory reserve. Recent studies on heated and humidified high flow oxygen (HFO) delivered through nasal cannula, show several positive effects on breathing pattern and ventilatory efficiency, mostly in critical care setting and at rest (Spoletini,2015). Some recent physiological studies have evidenced that high flows of humidified oxygen improve exercise performance in patients with COPD and severe oxygen dependency, in part by enhancing oxygenation (Chatila,2004). Recently, a pilot study by our group showed that HFO may improve the exercise performance in severe COPD patients with ventilatory limitation. This effect is associated to an improvement of oxygen saturation (SatO2) and perceived symptoms at iso-time (Cirio,2016). No clinical studies are available about the use of HFO during exercise training. The investigators hypothesize that, in severe COPD patients with CRF and exercise limitation , the use of HFO could improve the efficiency of ventilation, leading to an increase in the patient's exercise performance and outcome.
Primary aim will be to evaluate in patients COPD with CRF the difference in the endurance tolerance improvement (expressed in minutes) after an high intensity training program, at iso-FiO2, using HFO with respect to usual oxygen administration by " Venturi Mask" .
Secondary objectives will be to study effectiveness of HFO with respect to "Venturi Mask" in terms of improvement of meters of 6 Minute Walking Test, dyspnea at rest, peripheral and respiratory muscle strength,blood gases, motor and respiratory disability,quality of life,impact of the disease and patients satisfaction.
Read the detailed description
160 patients will be enrolled in 4 different hospitals. One of those, ICS Maugeri, will contribute with 5 different Institutes [Brescia, Pavia, Tradate (VA),Veruno (NO) and Cassano delle Murge (BA)]. Thus the total recruiting centers will be eight.
During the whole rehabilitation period, the patients will perform one training session/day.
The patients will use medications and oxygen therapy at rest as prescribed. The patients will perform no less than 20 training sessions within a period of one month. The rehabilitative intervention will be constantly supervised by a respiratory therapist.
The cycle load started from the 50% of the theoretical maximum watt (evaluated by 6 minutes walking test [6MWT] through the Luxton's equation) (Luxton,2008) and increased by Maltais's protocol (Maltais,1997). Run-in training session: all patients will be submitted to a preliminary 30 minute training under a Venturi mask to set the FiO2 able to maintain SpO2 constantly up to 93%. Usual nocturnal ventilation and nocturnal oxygen therapy under nasal cannula will be allowed.
Patients will be randomized to 2 groups:
- OXYGEN (Control Group, n = 80): the training will be performed using the Venturi mask with the FiO2 set during the run -in session.
- HFO (TREATMENT Group, n = 80): the training will be performed using the HFO device. Air-flow will be set at the highest value tolerated by the patient, until a maximum value of 60 l/min and with the same FiO2 set of the Control Group (iso-FiO2) during the run-in session.
The HFO will be administered using the AIRVO2® (Fisher\&Paykel- NewZealand, CE0123 - 93/42/CEE). Afterwards, the oxygen flow provided into the system will be progressively increased until the pre-fixed FiO2 will be reached, as displayed by the AIRVO2 monitor.
the investigators will expect an enrollmnet rate of at least 23 patients/center. An enrollment rate less than 12 patients/center will not guarantee 1 author name on the possible Scientific publication. All the centers will be named in a possible congress/poster presentation. The possible publication will consider that a) the study is under the endorsement of AIPO and ARIR societies and b) Authors acknowledge the Industry contribution.
Measures
At baseline (T0), for both groups the following clinical evaluations will be performed:
- Anthropometric (age, BMI, diagnosis)
- Scale of comorbidity (CIRS)
- Spirometry (FEV1 %prd, FVC %prd, FEV1/FVC)
At baseline (T0) and at the end of rehabilitative program (T1), an operator, unblinded to the study, will perform the following outcome measures:
- Constant load cycle-ergometer endurance [at work load of 80% of maximal load predicted by Luxon's equation (Luxton,2008)] under usual oxygen supply with nasal cannula
- Arterial blood gas analysis (ABG) under room air
- 6-min walking test (6MWT) under usual oxygen supply with nasal cannula
- Scale of the MRC dyspnea
- Quality of Life (MRF26 scale)
- Respiratory muscle strength (MIP and MEP)
- Biceps and Quadriceps muscle strength tested by manual dynamometer and MRC muscle scale
- Disability (Barthel index, Barthel dispnea)
- Impact of the disease (CAT scale)
During each training session the investigators will evaluate:
- Side effects (discomfort, severe dyspnea, dryness of mucosa , etc)
- delta increase in training prescription (% of variation in watts compared with the previous session)
Only at the end of the program (T1) the investigators will evaluate :
- patient satisfaction for training sessions with a Likert scale (0= no discomfort; 1 minimum discomfort; 2= moderate discomfort; 3 = high discomfort; 4= maximum discomfort)
- drops out (number and reasons: exacerbation, intolerance of treatment, refuse, early discharge, etc)
Statistical analysis will be performed using STATA 12. Descriptive data will be shown as mean ± SD.
The analyses will be conducted on a intention-to-treat (all randomized patients) or per-protocol (all completers) basis. A two-sample t test was used to explore differences in: 1. baseline characteristics intervention and control groups, 2. between improvers and non improvers, 3.between completers and 4. dropouts and to assess differences in changes of parameters following the rehabilitation program between intervention and control groups. Wilcoxon matched-paired tests and Mann-Whitney U test will be employed for nonparametric data. Frequency distributions will be analyzed with χ2 test. Data will be considered significant for p<0.05.
The sample estimated size for two sample comparison of means on primary outcome (endurance time evaluated by cicloergometer at costant load) (alpha error 0.05, beta error=0.90 considering mean control group=150 s, mean treatment group=280s, standard deviation for both groups 250s ) is 156 patients
- Conditions
- COPD
- Being tested
- HFO
- 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.
HFODevice
Training will be done using the HFO device. Air-flow will set at the highest value tolerated by the patients, until a maximum value of 60 l/min permitted and FiO2 set during the run-in. The HFO will be administered using the AIRVO2® (Fisher\&Paykel- NewZealand). Afterwards, the oxygen flow provided into the system will be progressively increased until the pre-fixed FiO2 will be reached, as displayed by the AIRVO2 monitor.
| Study group | Role | What they receive |
|---|---|---|
| Oxygen | No intervention | The training will be performed using oxygen by the Venturi mask with the FiO2 set during the run - in session. |
| HFO | Experimental | The training will be performed using the HFO device during the run - in session at iso_FiO2 as in the Control Group (Oxygen by Venturi mask). Receives: Device: HFO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness on endurance tolerance
To evaluate the difference in the endurance tolerance improvement (endurance time) with a costant load cycloergometer test.
Measured: At Baseline
Secondary outcomes (9)
Effectiveness on functional capacity
To evaluate effectiveness of HFO with respect to "Venturi Mask" in terms of improvement of meters at 6-min walking test.
Measured: At 1 month
Effectiveness on dyspnea
To evaluate effectiveness of HFO with respect to "Venturi Mask" in terms of dyspnea evaluation, MRC scale for dyspnea will be used.
Measured: At 1 month
Effectiveness on respitarory muscle strength
To evaluate effectiveness of HFO with respect to "Venturi Mask" in terms of improvement in respiratory muscle strenght measured by MIP/MEP.
Measured: At 1 month
Effectiveness on peripheral muscle strenght
To evaluate effectiveness of HFO with respect to "Venturi Mask" in terms of improvement in peripheral muscles [biceps and quadriceps] evaluated by manual dinamometer and MRC muscle scale.
Measured: At 1 month
Effectiveness on blood gases
To evaluate improvement of blood gases (PaO2/FiO2 PaCO2, pH) arterial blood gases analysis will be used.
Measured: At one month
Effectiveness on disability
To evaluate disability of HFO with respect to "Venturi Mask" , disability will be measured by Barthel index and Barthel Dyspnea.
Measured: At 1 month
Effectiveness on quality of life
To evaluate quality of life MRF-26 will be used.
Measured: At 1 month
Effectiveness on impact of the disease
To evaluate impact of disease CAT will be used.
Measured: At 1 month
Effectivenes on satisfaction
Patient satisfaction for training session will be assessed by a Likert scale 0-4 (0= no discomfort; 1= minimum discomfort; 2=moderate discomfort; 3= high discomfort; 4= maximum discomfort).
Measured: At 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start6 Nov 2017
- Primary completion8 Dec 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Ospedale Maggiore di Crema, University of Modena and Reggio Emilia, Villa Pineta Hospital, Fisher and Paykel Healthcare, Associazione Riabilitatori Insufficienza Respiratoria
- Responsible party
- Sponsor
- Investigators
- Michele Vitacca, MD, Principal investigator, ICS Maugeri Lumezzane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322787
- Sponsor's protocol ID
- ICS Maugeri - CE2109
- Acronym
- HFO
- Status last verified
- May 2019
- First submitted
- 3 Oct 2017
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Troosters T, Casaburi R, Gosselink R, Decramer M. Pulmonary rehabilitation in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 Jul 1;172(1):19-38. doi: 10.1164/rccm.200408-1109SO. Epub 2005 Mar 18. No abstract available.
PubMed 15778487O'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 11282762Elbehairy AF, Ciavaglia CE, Webb KA, Guenette JA, Jensen D, Mourad SM, Neder JA, O'Donnell DE; Canadian Respiratory Research Network. Pulmonary Gas Exchange Abnormalities in Mild Chronic Obstructive Pulmonary Disease. Implications for Dyspnea and Exercise Intolerance. Am J Respir Crit Care Med. 2015 Jun 15;191(12):1384-94. doi: 10.1164/rccm.201501-0157OC.
PubMed 25826478Spoletini 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 25742321Chatila W, Nugent T, Vance G, Gaughan J, Criner GJ. The effects of high-flow vs low-flow oxygen on exercise in advanced obstructive airways disease. Chest. 2004 Oct;126(4):1108-15. doi: 10.1378/chest.126.4.1108.
PubMed 15486371Cirio S, Piran M, Vitacca M, Piaggi G, Ceriana P, Prazzoli M, Paneroni M, Carlucci A. Effects of heated and humidified high flow gases during high-intensity constant-load exercise on severe COPD patients with ventilatory limitation. Respir Med. 2016 Sep;118:128-132. doi: 10.1016/j.rmed.2016.08.004. Epub 2016 Aug 8.
PubMed 27578482Luxton N, Alison JA, Wu J, Mackey MG. Relationship between field walking tests and incremental cycle ergometry in COPD. Respirology. 2008 Nov;13(6):856-62. doi: 10.1111/j.1440-1843.2008.01355.x.
PubMed 18811884Maltais F, LeBlanc P, Jobin J, Berube C, Bruneau J, Carrier L, Breton MJ, Falardeau G, Belleau R. Intensity of training and physiologic adaptation in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1997 Feb;155(2):555-61. doi: 10.1164/ajrccm.155.2.9032194.
PubMed 9032194Shah S, Vanclay F, Cooper B. Improving the sensitivity of the Barthel Index for stroke rehabilitation. J Clin Epidemiol. 1989;42(8):703-9. doi: 10.1016/0895-4356(89)90065-6.
PubMed 2760661Vitacca M, Paneroni M, Baiardi P, De Carolis V, Zampogna E, Belli S, Carone M, Spanevello A, Balbi B, Bertolotti G. Development of a Barthel Index based on dyspnea for patients with respiratory diseases. Int J Chron Obstruct Pulmon Dis. 2016 Jun 7;11:1199-206. doi: 10.2147/COPD.S104376. eCollection 2016.
PubMed 27354778Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.
PubMed 10377201Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.
PubMed 19720809Vidotto G, Carone M, Jones PW, Salini S, Bertolotti G; Quess Group. Maugeri Respiratory Failure questionnaire reduced form: a method for improving the questionnaire using the Rasch model. Disabil Rehabil. 2007 Jul 15;29(13):991-8. doi: 10.1080/09638280600926678.
PubMed 17612984Linn BS, Linn MW, Gurel L. Cumulative illness rating scale. J Am Geriatr Soc. 1968 May;16(5):622-6. doi: 10.1111/j.1532-5415.1968.tb02103.x. No abstract available.
PubMed 5646906Vitacca M, Paneroni M, Zampogna E, Visca D, Carlucci A, Cirio S, Banfi P, Pappacoda G, Trianni L, Brogneri A, Belli S, Paracchini E, Aliani M, Spinelli V, Gigliotti F, Lanini B, Lazzeri M, Clini EM, Malovini A, Ambrosino N; Associazione Italiana Riabilitatori Insufficienza Respiratoria and Associazione Italiana Pneumologi Ospedalieri rehabilitation group. High-Flow Oxygen Therapy During Exercise Training in Patients With Chronic Obstructive Pulmonary Disease and Chronic Hypoxemia: A Multicenter Randomized Controlled Trial. Phys Ther. 2020 Aug 12;100(8):1249-1259. doi: 10.1093/ptj/pzaa076.
PubMed 32329780
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Training Under High Flow Oxygen (HFO) Device on Endurance Tolerance in Patients With COPD and Chronic Respiratory Failure: a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT03322787
- Acronym / sponsor ID
- HFO / ICS Maugeri - CE2109
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Ospedale Maggiore di Crema, University of Modena and Reggio Emilia, Villa Pineta Hospital, Fisher and Paykel Healthcare, Associazione Riabilitatori Insufficienza Respiratoria
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 8 Dec 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 26 Oct 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.
Current literature clearly shows the benefit of pulmonary rehabilitation in symptomatic COPD (Trooster,2005). However, these patients are frequently unable to sustain a work-load sufficiently high to obtain a full benefit on exercise tolerance (Trooster,2005). Especially in patients with Chronic Respiratory Failure (CRF), the development of hypoxia (O'Donnel,2001) and the increase of dead space (Elbehairy,2015) during effort explain the out-of-proportion increase in ventilation leading to an early achievement of the ventilatory reserve. Recent studies on heated and humidified high flow oxygen (HFO) delivered through nasal cannula, show several positive effects on breathing pattern and ventilatory efficiency, mostly in critical care setting and at rest (Spoletini,2015). Some recent physiological studies have evidenced that high flows of humidified oxygen improve exercise performance in patients with COPD and severe oxygen dependency, in part by enhancing oxygenation (Chatila,2004). Recently, a pilot study by our group showed that HFO may improve the exercise performance in severe COPD patients with ventilatory limitation. This effect is associated to an improvement of oxygen saturation (SatO2) and perceived symptoms at iso-time (Cirio,2016). No clinical studies are available about the use of HFO during exercise training. The investigators hypothesize that, in severe COPD patients with CRF and exercise limitation , the use of HFO could improve the efficiency of ventilation, leading to an increase in the patient's exercise performance and outcome.
Primary aim will be to evaluate in patients COPD with CRF the difference in the endurance tolerance improvement (expressed in minutes) after an high intensity training program, at iso-FiO2, using HFO with respect to usual oxygen administration by " Venturi Mask" .
Secondary objectives will be to study effectiveness of HFO with respect to "Venturi Mask" in terms of improvement of meters of 6 Minute Walking Test, dyspnea at rest, peripheral and respiratory muscle strength,blood gases, motor and respiratory disability,quality of life,impact of the disease and patients satisfaction.
Detailed description
160 patients will be enrolled in 4 different hospitals. One of those, ICS Maugeri, will contribute with 5 different Institutes [Brescia, Pavia, Tradate (VA),Veruno (NO) and Cassano delle Murge (BA)]. Thus the total recruiting centers will be eight.
During the whole rehabilitation period, the patients will perform one training session/day.
The patients will use medications and oxygen therapy at rest as prescribed. The patients will perform no less than 20 training sessions within a period of one month. The rehabilitative intervention will be constantly supervised by a respiratory therapist.
The cycle load started from the 50% of the theoretical maximum watt (evaluated by 6 minutes walking test [6MWT] through the Luxton's equation) (Luxton,2008) and increased by Maltais's protocol (Maltais,1997). Run-in training session: all patients will be submitted to a preliminary 30 minute training under a Venturi mask to set the FiO2 able to maintain SpO2 constantly up to 93%. Usual nocturnal ventilation and nocturnal oxygen therapy under nasal cannula will be allowed.
Patients will be randomized to 2 groups:
- OXYGEN (Control Group, n = 80): the training will be performed using the Venturi mask with the FiO2 set during the run -in session.
- HFO (TREATMENT Group, n = 80): the training will be performed using the HFO device. Air-flow will be set at the highest value tolerated by the patient, until a maximum value of 60 l/min and with the same FiO2 set of the Control Group (iso-FiO2) during the run-in session.
The HFO will be administered using the AIRVO2® (Fisher\&Paykel- NewZealand, CE0123 - 93/42/CEE). Afterwards, the oxygen flow provided into the system will be progressively increased until the pre-fixed FiO2 will be reached, as displayed by the AIRVO2 monitor.
the investigators will expect an enrollmnet rate of at least 23 patients/center. An enrollment rate less than 12 patients/center will not guarantee 1 author name on the possible Scientific publication. All the centers will be named in a possible congress/poster presentation. The possible publication will consider that a) the study is under the endorsement of AIPO and ARIR societies and b) Authors acknowledge the Industry contribution.
Measures
At baseline (T0), for both groups the following clinical evaluations will be performed:
- Anthropometric (age, BMI, diagnosis)
- Scale of comorbidity (CIRS)
- Spirometry (FEV1 %prd, FVC %prd, FEV1/FVC)
At baseline (T0) and at the end of rehabilitative program (T1), an operator, unblinded to the study, will perform the following outcome measures:
- Constant load cycle-ergometer endurance [at work load of 80% of maximal load predicted by Luxon's equation (Luxton,2008)] under usual oxygen supply with nasal cannula
- Arterial blood gas analysis (ABG) under room air
- 6-min walking test (6MWT) under usual oxygen supply with nasal cannula
- Scale of the MRC dyspnea
- Quality of Life (MRF26 scale)
- Respiratory muscle strength (MIP and MEP)
- Biceps and Quadriceps muscle strength tested by manual dynamometer and MRC muscle scale
- Disability (Barthel index, Barthel dispnea)
- Impact of the disease (CAT scale)
During each training session the investigators will evaluate:
- Side effects (discomfort, severe dyspnea, dryness of mucosa , etc)
- delta increase in training prescription (% of variation in watts compared with the previous session)
Only at the end of the program (T1) the investigators will evaluate :
- patient satisfaction for training sessions with a Likert scale (0= no discomfort; 1 minimum discomfort; 2= moderate discomfort; 3 = high discomfort; 4= maximum discomfort)
- drops out (number and reasons: exacerbation, intolerance of treatment, refuse, early discharge, etc)
Statistical analysis will be performed using STATA 12. Descriptive data will be shown as mean ± SD.
The analyses will be conducted on a intention-to-treat (all randomized patients) or per-protocol (all completers) basis. A two-sample t test was used to explore differences in: 1. baseline characteristics intervention and control groups, 2. between improvers and non improvers, 3.between completers and 4. dropouts and to assess differences in changes of parameters following the rehabilitation program between intervention and control groups. Wilcoxon matched-paired tests and Mann-Whitney U test will be employed for nonparametric data. Frequency distributions will be analyzed with χ2 test. Data will be considered significant for p<0.05.
The sample estimated size for two sample comparison of means on primary outcome (endurance time evaluated by cicloergometer at costant load) (alpha error 0.05, beta error=0.90 considering mean control group=150 s, mean treatment group=280s, standard deviation for both groups 250s ) is 156 patients
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen | No intervention | –The training will be performed using oxygen by the Venturi mask with the FiO2 set during the run - in session. |
| HFO | Experimental | Device: HFOThe training will be performed using the HFO device during the run - in session at iso_FiO2 as in the Control Group (Oxygen by Venturi mask). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD and CRF diagnosis under LTOT,
- clinical stability (pH > 7.35 and < 7.46, no change in respiratory drugs therapy during the last seven days)
Key exclusion criteria (3 listed)
- orthopedic or neurological disease,
- cognitive impairment (Mini Mental State Examination < 22)
- anamnestic history of ischemic heart disease or heart failure, COPD+ fibrosis and COPD+ OSAS.
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 |
|---|---|---|
| HFOTraining will be done using the HFO device. Air-flow will set at the highest value tolerated by the patients, until a maximum value of 60 l/min permitted and FiO2 set during the run-in. The HFO will be administered using the AIRVO2® (Fisher\&Paykel- NewZealand). Afterwards, the oxygen flow provided into the system will be progressively increased until the pre-fixed FiO2 will be reached, as displayed by the AIRVO2 monitor. | Device | HFO |
Primary outcome
Effectiveness on endurance tolerance
Time frame: At Baseline
To evaluate the difference in the endurance tolerance improvement (endurance time) with a costant load cycloergometer test.
9 secondary outcomes
Effectiveness on functional capacity
Time frame: At 1 month
Effectiveness on dyspnea
Time frame: At 1 month
Effectiveness on respitarory muscle strength
Time frame: At 1 month
Effectiveness on peripheral muscle strenght
Time frame: At 1 month
Effectiveness on blood gases
Time frame: At one month
Effectiveness on disability
Time frame: At 1 month
Effectiveness on quality of life
Time frame: At 1 month
Effectiveness on impact of the disease
Time frame: At 1 month
Effectivenes on satisfaction
Time frame: At 1 month
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 29 May 2019.
- Background: PubMed 15778487Troosters T, Casaburi R, Gosselink R, Decramer M. Pulmonary rehabilitation in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 Jul 1;172(1):19-38. doi: 10.1164/rccm.200408-1109SO. Epub 2005 Mar 18. No abstract available.
- 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 25826478Elbehairy AF, Ciavaglia CE, Webb KA, Guenette JA, Jensen D, Mourad SM, Neder JA, O'Donnell DE; Canadian Respiratory Research Network. Pulmonary Gas Exchange Abnormalities in Mild Chronic Obstructive Pulmonary Disease. Implications for Dyspnea and Exercise Intolerance. Am J Respir Crit Care Med. 2015 Jun 15;191(12):1384-94. doi: 10.1164/rccm.201501-0157OC.
- Background: 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.
- Background: PubMed 15486371Chatila W, Nugent T, Vance G, Gaughan J, Criner GJ. The effects of high-flow vs low-flow oxygen on exercise in advanced obstructive airways disease. Chest. 2004 Oct;126(4):1108-15. doi: 10.1378/chest.126.4.1108.
- Background: PubMed 27578482Cirio S, Piran M, Vitacca M, Piaggi G, Ceriana P, Prazzoli M, Paneroni M, Carlucci A. Effects of heated and humidified high flow gases during high-intensity constant-load exercise on severe COPD patients with ventilatory limitation. Respir Med. 2016 Sep;118:128-132. doi: 10.1016/j.rmed.2016.08.004. Epub 2016 Aug 8.
- Background: PubMed 18811884Luxton N, Alison JA, Wu J, Mackey MG. Relationship between field walking tests and incremental cycle ergometry in COPD. Respirology. 2008 Nov;13(6):856-62. doi: 10.1111/j.1440-1843.2008.01355.x.
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- Background: PubMed 27354778Vitacca M, Paneroni M, Baiardi P, De Carolis V, Zampogna E, Belli S, Carone M, Spanevello A, Balbi B, Bertolotti G. Development of a Barthel Index based on dyspnea for patients with respiratory diseases. Int J Chron Obstruct Pulmon Dis. 2016 Jun 7;11:1199-206. doi: 10.2147/COPD.S104376. eCollection 2016.
- Background: PubMed 10377201Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.
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- 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.
Michele Vitacca, MD principal investigator
ICS Maugeri Lumezzane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFO in people with COPD, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
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 3 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 29 May 2019. 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 Italy. 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?
Effectiveness on endurance tolerance (time frame: At 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 NCT03322787, which also lists 15 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 29 May 2019.