European Journal of Heart Failure (2014) 16, 574–582 doi:10.1002/ejhf.70
Combined aerobic/inspiratory muscle training vs. aerobic training in patients with chronic heart failure The Vent-HeFT trial: a European prospective multicentre randomized trial Stamatis Adamopoulos1, Jean-Paul Schmid2, Paul Dendale3,4, Daniel Poerschke2, Dominique Hansen3,4, Athanasios Dritsas1, Alexandros Kouloubinis1, Toon Alders3, Aggeliki Gkouziouta1, Ilse Reyckers3, Vasiliki Vartela1, Nikos Plessas1, Costas Doulaptsis1, Hugo Saner2, and Ioannis D. Laoutaris1* 1 Heart
Failure Unit, Stress Testing & Rehabilitation, Onassis Cardiac Surgery Center, Athens, Greece; 2 Division of Cardiology, Cardiovascular Prevention, Rehabilitation & Sports Medicine, Bern University Hospital, and University of Bern, Switzerland; 3 Rehabilitation and Health Center, Heart Centre Hasselt, Hasselt, Belgium; and 4 Hasselt University, Faculty of Medicine and Life Sciences, Hasselt, Belgium Received 1 October 2013; revised 19 December 2013; accepted 3 January 2014 ; online publish-ahead-of-print 14 March 2014
Aims
Vent-HeFT is a multicentre randomized trial designed to investigate the potential additive benefits of inspiratory muscle training (IMT) on aerobic training (AT) in patients with chronic heart failure (CHF). ..................................................................................................................................................................... Methods Forty-three CHF patients with a mean age of 58 ± 12 years, peak oxygen consumption (peak VO2 ) 17.9 ± 5 mL/kg/min, and results and LVEF 29.5 ± 5% were randomized to an AT/IMT group (n = 21) or to an AT/SHAM group (n = 22) in a 12-week exercise programme. AT involved 45 min of ergometer training at 70–80% of maximum heart rate, three times a week for both groups. In the AT/IMT group, IMT was performed at 60% of sustained maximal inspiratory pressure (SPImax ) while in the AT/SHAM group it was performed at 10% of SPImax , using a computer biofeedback trainer for 30 min, three times a week. At baseline and at 3 months, patients were evaluated for exercise capacity, lung function, inspiratory muscle strength (PImax ) and work capacity (SPImax ), quality of life (QoL), LVEF and LV diameter, dyspnoea, C-reactive protein (CRP), and NT-proBNP. IMT resulted in a significantly higher benefit in SPImax (P = 0.02), QoL (P = 0.002), dyspnoea (P = 0.004), CRP (P = 0.03), and NT-proBNP (P = 0.004). In both AT/IMT and AT/SHAM groups PImax (P < 0.001, P = 0.02), peak VO2 (P = 0.008, P = 0.04), and LVEF (P = 0.005, P = 0.002) improved significantly; however, without an additional benefit for either of the groups. ..................................................................................................................................................................... Conclusion This randomized multicentre study demonstrates that IMT combined with aerobic training provides additional benefits in functional and serum biomarkers in patients with moderate CHF. These findings advocate for application of IMT in cardiac rehabilitation programmes.
.......................................................................................................... Aerobic training • Inspiratory muscle training • Chronic heart failure • Quality of life • Exercise • Rehabilitation • Vent-HeFT trial
Introduction Exercise intolerance and dyspnoea are the major symptoms of patients with chronic heart failure (CHF) and are associated
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Keywords
with a poor quality of life (QoL). In addition to impaired central haemodynamics, symptoms may be attributed to changes in peripheral skeletal muscles which include a shift from type I to type IIb fibres, reduced oxidative capacity, and muscle atrophy.1
*Corresponding author. Vent-HeFT trial Co-ordinator/Stress Testing & Rehabilitation Department, Onassis Cardiac Surgery Center, 356 Sygrou Blv., 176 74, Athens, Greece. Tel: +30 210 9493000, Fax: +30 210 9493186, Email:
[email protected]
© 2014 The Authors European Journal of Heart Failure © 2014 European Society of Cardiology
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Aerobic training (AT) programmes may partially reverse these changes, improve or maintain functional capacity, and restore QoL in patients with moderate to severe CHF.2 – 4 These exercise programmes have gained increased recognition during the past years and are recommended by the European Society of Cardiology (ESC) guidelines for the diagnosis and treatment of acute and chronic heart failure,5 and the European Association for Cardiovascular Prevention and Rehabilitation (EACPR).6 Human and animal studies have also found histological and biochemical alterations of the diaphragm muscle in CHF. An opposite muscle fibre shift to the peripheral muscles was observed, however, with concurrent fibre atrophy and reduced mitochondrial oxidative capacity attributed to two competing influences on diaphragmatic adaptations, a chronic increase in respiratory load and a systemic myopathy.7 – 9 . Early diaphragmatic fatigue with a decrease in both inspiratory muscle strength (PImax ) and endurance have also been documented, associated with an increased sensation of dyspnoea and reduced functional status of patients with CHF.10 – 13 Thus, during the last decade, several studies on selective inspiratory muscle training (IMT) have been reported.14 – 20 In order to verify these single-centre results, a prospective randomized multicentre trial was initiated. The aim of the study was to investigate the potential additive benefits of IMT on standard AT on primary outcomes such as respiratory muscle function, exercise capacity, sensation of dyspnoea, and QoL, as well as on secondary outcomes which included pulmonary lung volumes, LV function and structure, and serum biomarkers of inflammation and myocardial stress.
Methods Study design The Vent-HeFT trial was announced and registered within the EACPR as a Multicenter European randomized controlled trial (http://www.escardio.org/communities/EACPR/news/Pages/VENTHEFT-Trial.aspx). Patients with CHF were recruited from the outpatient cardiac rehabilitation units of three different centres: the Onassis Cardiac Surgery Center (OCSC) in Athens, Greece, the University Hospital in Bern (UHB), Switzerland, and the Heart Centre Hasselt (HCH) in Hasselt, Belgium. Centre eligibility included the availability of a structured comprehensive rehabilitation programme, which, apart from AT, could easily implement IMT using a computing system. Inclusion criteria for patients were age >18, stable moderate to severe CHF with systolic dysfunction (LVEF ≤35%), NYHA functional class II–III, and a signed informed consent (compatible with each centre’s ethics committee regulations). Exclusion criteria consisted of pulmonary limitation [forced vital capacity (FVC)
