Inspiratory muscle training protocol for patients with chronic obstructive pulmonary disease (IMTCO study): a multicentre randomised controlled trial

被引:59
作者
Charususin, Noppawan [1 ,2 ]
Gosselink, Rik [1 ,3 ]
Decramer, Marc [3 ]
McConnell, Alison [4 ]
Saey, Didier [5 ]
Maltais, Francois [5 ]
Derom, Eric [6 ]
Vermeersch, Stefanie [6 ]
van Helvoort, Hanneke [7 ]
Heijdra, Yvonne [7 ]
Klaassen, Mariska [7 ]
Gloeckl, Rainer [8 ]
Kenn, Klaus [8 ]
Langer, Daniel [1 ,3 ]
机构
[1] Univ Leuven, Dept Rehabil Sci, Louvain, Belgium
[2] Thammasat Univ, Dept Phys Therapy, Pathum Thani, Thailand
[3] Univ Hosp Gasthuisberg, Resp Rehabil & Resp Div, Louvain, Belgium
[4] Brunel Univ, Ctr Sports Med & Human Performance, London, England
[5] Univ Laval, Inst Univ Cardiol & Pneumol Quebec, Ctr Rech, Quebec City, PQ, Canada
[6] Univ Hosp Ghent, Dept Pulmonol, Ghent, Belgium
[7] Radboud Univ Nijmegen, Med Ctr, Dept Pulm Dis, NL-6525 ED Nijmegen, Netherlands
[8] Schon Klin Berchtesgaden, Dept Resp Med & Sports Therapy, Schonau Am Konigssee, Germany
关键词
IMPROVE EXERCISE TOLERANCE; EXPIRATORY LUNG-VOLUME; RESPIRATORY MUSCLES; COPD; REHABILITATION; RELIABILITY; STANDARDIZATION; PRESSURES; STRENGTH; VALIDITY;
D O I
10.1136/bmjopen-2013-003101
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Introduction: Inspiratory muscle training (IMT) has been applied during pulmonary rehabilitation in patients with chronic obstructive pulmonary disease (COPD). However, it remains unclear if the addition of IMT to a general exercise training programme leads to additional clinically relevant improvements in patients with COPD. In this study, we will investigate whether the addition of IMT to a general exercise training programme improves 6 min walking distance, health-related quality of life, daily physical activity and inspiratory muscle function in patients with COPD with inspiratory muscle weakness. Methods and analysis: Patients with COPD (n=170) with inspiratory muscle weakness (P-i,P-max <60 cm H2O or <50% pred) will be recruited to a multicentre randomised placebo controlled trial of IMT and allocated into one of the two groups. Patients in both groups will follow a 3 month general exercise training programme, in combination with home-based IMT. IMT will be performed with a recently developed device (POWERbreathe KH1). This device applies an inspiratory load that is provided by an electronically controlled valve (variable flow resistive load). The intervention group (n=85) will undertake an IMT programme at a high intensity (>= 50% of their P-i,P-max), whereas the placebo group (n=85) will undertake IMT at a low training intensity (<= 10% of P-i,P-max). Total daily IMT time for both groups will be 21 min (6 cycles of 30 breaths). Improvement in the 6 min walking distance will be the primary outcome. Inspiratory muscle function, health-related quality of life and daily physical activity will be assessed as secondary outcomes. Ethics and dissemination: Ethics approval has been obtained from relevant centre committees and the study has been registered in a publicly accessible clinical trial database. The results will be easily interpretable and should immediately be communicated to healthcare providers, patients and the general public. Results: This can be incorporated into evidence-based treatment recommendations for clinical practice.
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页数:7
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