Effect of high-flow nasal therapy during exercise training in COPD patients with chronic respiratory failure: study protocol for a randomised controlled trial.
Administration, Intranasal
Cannula
Exercise Therapy
Exercise Tolerance
Humans
Italy
Lung
/ physiopathology
Multicenter Studies as Topic
Oxygen Inhalation Therapy
/ instrumentation
Pulmonary Disease, Chronic Obstructive
/ diagnosis
Randomized Controlled Trials as Topic
Recovery of Function
Respiration
Respiratory Insufficiency
/ diagnosis
Time Factors
Treatment Outcome
Exercise tolerance
Outcome
Oxygen
Rehabilitation
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
08 Jun 2019
08 Jun 2019
Historique:
received:
27
02
2019
accepted:
13
05
2019
entrez:
10
6
2019
pubmed:
10
6
2019
medline:
3
1
2020
Statut:
epublish
Résumé
The benefit of pulmonary rehabilitation (PR) in symptomatic chronic obstructive pulmonary disease (COPD) is well known. However, advanced patients with chronic respiratory failure (CRF), a category excluded from most studies, are frequently unable to sustain a work-load sufficiently high to obtain the full benefit of PR on exercise tolerance. Recent studies involving heated and humidified high flow oxygen therapy (HFOT) showed positive effects on breathing pattern and ventilatory efficiency during effort. We thus plan to compare, in COPD patients with CRF undergoing a high-intensity exercise programme, the effect of using HFOT versus standard oxygen delivery via Venturi Mask (V-mask), at the same inspiratory oxygen fraction, on improving exercise endurance. This is a multicentre randomised controlled trial that will involve 156 COPD inpatients with CRF recruited from seven PR hospitals. Patients will be randomised to one of two groups - V-mask versus HFOT. All patients will undergo the same high-intensity exercise programme using either of the oxygen delivery devices as per their group allocation. Training will consist of 20 sessions, over 1 month (5 sessions per week) within the hospitalisation period. Anthropometric and clinical data, including body mass index, diagnosis, spirometry and comorbidities (Cumulative Rating Scale) will be collected at baseline. At baseline and at the end of the exercise programme (primary assessment time) evaluation will include exercise tolerance (Constant Work Rate Exercise Test) (primary outcome), functional capacity (6-min walk test), maximal inspiratory pressure/maximal expiratory pressure, peripheral muscle strength (biceps and quadriceps) by manual dynamometer, respiratory exchanges (blood gases analysis), disability (Barthel Index and Barthel Dyspnoea Index), impact of disease (COPD Assessment test), and quality of life (Maugeri Respiratory Failure Scale-26). At the end of the training period, patient satisfaction will be evaluated. This study will add knowledge about the exercise response in advanced COPD with CRF and verify if an alternative tool, namely HFOT, can increase the benefit obtained from PR. ClinicalTrials.gov ID NET03322787 Registered: 6 November 2017.
Sections du résumé
BACKGROUND
BACKGROUND
The benefit of pulmonary rehabilitation (PR) in symptomatic chronic obstructive pulmonary disease (COPD) is well known. However, advanced patients with chronic respiratory failure (CRF), a category excluded from most studies, are frequently unable to sustain a work-load sufficiently high to obtain the full benefit of PR on exercise tolerance. Recent studies involving heated and humidified high flow oxygen therapy (HFOT) showed positive effects on breathing pattern and ventilatory efficiency during effort. We thus plan to compare, in COPD patients with CRF undergoing a high-intensity exercise programme, the effect of using HFOT versus standard oxygen delivery via Venturi Mask (V-mask), at the same inspiratory oxygen fraction, on improving exercise endurance.
METHODS/DESIGN
METHODS
This is a multicentre randomised controlled trial that will involve 156 COPD inpatients with CRF recruited from seven PR hospitals. Patients will be randomised to one of two groups - V-mask versus HFOT. All patients will undergo the same high-intensity exercise programme using either of the oxygen delivery devices as per their group allocation. Training will consist of 20 sessions, over 1 month (5 sessions per week) within the hospitalisation period. Anthropometric and clinical data, including body mass index, diagnosis, spirometry and comorbidities (Cumulative Rating Scale) will be collected at baseline. At baseline and at the end of the exercise programme (primary assessment time) evaluation will include exercise tolerance (Constant Work Rate Exercise Test) (primary outcome), functional capacity (6-min walk test), maximal inspiratory pressure/maximal expiratory pressure, peripheral muscle strength (biceps and quadriceps) by manual dynamometer, respiratory exchanges (blood gases analysis), disability (Barthel Index and Barthel Dyspnoea Index), impact of disease (COPD Assessment test), and quality of life (Maugeri Respiratory Failure Scale-26). At the end of the training period, patient satisfaction will be evaluated.
DISCUSSION
CONCLUSIONS
This study will add knowledge about the exercise response in advanced COPD with CRF and verify if an alternative tool, namely HFOT, can increase the benefit obtained from PR.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov ID NET03322787 Registered: 6 November 2017.
Identifiants
pubmed: 31176375
doi: 10.1186/s13063-019-3440-2
pii: 10.1186/s13063-019-3440-2
pmc: PMC6556225
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
336Références
Am J Respir Crit Care Med. 2001 Mar;163(4):892-8
pubmed: 11282762
Am J Respir Crit Care Med. 2001 Apr;163(5):1256-76
pubmed: 11316667
Chest. 2002 Feb;121(2):393-400
pubmed: 11834648
J Psychiatr Res. 1975 Nov;12(3):189-98
pubmed: 1202204
Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624
pubmed: 12186831
Eur Respir J. 2004 Aug;24(2):313-22
pubmed: 15332404
Med Educ. 2004 Dec;38(12):1217-8
pubmed: 15566531
Am J Respir Crit Care Med. 2005 Jul 1;172(1):19-38
pubmed: 15778487
Eur Respir J. 2005 Jul;26(1):1-2
pubmed: 15994380
Disabil Rehabil. 2007 Jul 15;29(13):991-8
pubmed: 17612984
Respir Med. 2007 Dec;101(12):2447-53
pubmed: 17728121
Thorax. 2008 Feb;63(2):115-21
pubmed: 17901158
Respirology. 2008 Nov;13(6):856-62
pubmed: 18811884
J Rehabil Med. 2008 Aug;40(8):665-71
pubmed: 19020701
Scand J Med Sci Sports. 2010 Aug;20(4):644-50
pubmed: 19602182
Eur Respir J. 2009 Sep;34(3):648-54
pubmed: 19720809
Respir Med. 2013 Mar;107(3):394-400
pubmed: 23245993
Cochrane Database Syst Rev. 2014 May 14;(5):CD007714
pubmed: 24823712
Eur Respir J. 2014 Dec;44(6):1428-46
pubmed: 25359355
Am J Respir Crit Care Med. 2015 Jun 15;191(12):1384-94
pubmed: 25826478
Eur Respir J. 2016 Feb;47(2):429-60
pubmed: 26797036
Thorax. 2016 Aug;71(8):759-61
pubmed: 27015801
Int J Chron Obstruct Pulmon Dis. 2016 May 25;11:1077-85
pubmed: 27307723
Int J Chron Obstruct Pulmon Dis. 2016 Jun 07;11:1199-206
pubmed: 27354778
Respir Med. 2016 Sep;118:128-132
pubmed: 27578482
J Appl Physiol (1985). 2017 Jan 1;122(1):82-88
pubmed: 27815367
Am J Phys Med Rehabil. 2017 Aug;96(8):541-548
pubmed: 28099192
BMJ Open Respir Res. 2017 Aug 16;4(1):e000191
pubmed: 29071072
Int Disabil Stud. 1988;10(2):61-3
pubmed: 3403500
J Am Geriatr Soc. 1968 May;16(5):622-6
pubmed: 5646906
Thorax. 1993 Jul;48(7):708-13
pubmed: 8153918
Phys Ther. 1996 Mar;76(3):248-59
pubmed: 8602410
Am J Respir Crit Care Med. 1997 Feb;155(2):555-61
pubmed: 9032194
Eur Respir J. 1997 Feb;10(2):417-23
pubmed: 9042643