• Noppawan Charususin, Rik Gosselink, Marc Decramer, Alison McConnell, Didier Saey, Francois Maltais, Eric Derom, Stefanie Vermeersch, Hanneke van Helvoort, Yvonne Heijdra, Mariska Klaassen, Rainer Glöckl, Klaus Kenn, and Daniel Langer.
• Department of Rehabilitation Sciences, University of Leuven, Leuven, Belgium.
• BMJ Open. 2013 Aug 5; 3 (8).

IntroductionInspiratory 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 AnalysisPatients with COPD (n=170) with inspiratory muscle weakness (Pi,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 Pi,max), whereas the placebo group (n=85) will undertake IMT at a low training intensity (≤10% of Pi,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 DisseminationEthics 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.ResultsThis can be incorporated into evidence-based treatment recommendations for clinical practice.ClinicaltrialsgovNCT01397396.

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