Respiratory muscle training in patients recovering recent open cardiothoracic surgery: a randomized-controlled trial

Ernesto Crisafulli, Elena Venturelli, Gherardo Siscaro, Fabio Florini, Alessandra Papetti, Daniela Lugli, Massimo Cerulli, Enrico Clini, Ernesto Crisafulli, Elena Venturelli, Gherardo Siscaro, Fabio Florini, Alessandra Papetti, Daniela Lugli, Massimo Cerulli, Enrico Clini

Abstract

Objectives: To evaluate the clinical efficacy and feasibility of an expiratory muscle training (EMT) device (Respilift) applied to patients recovering from recent open cardiothoracic surgery (CTS).

Design: Prospective, double-blind, 14-day randomised-controlled trial.

Participants and setting: A total of 60 inpatients recovering from recent CTS and early admitted to a pulmonary rehabilitation program. Interventions. Chest physiotherapy plus EMT with a resistive load of 30 cm H2O for active group and chest physiotherapy plus EMT with a sham load for control group.

Measures: Changes in maximal expiratory pressure (MEP) were considered as primary outcome, while maximal inspiratory pressures (MIP), dynamic and static lung volumes, oxygenation, perceived symptoms of dyspnoea, thoracic pain, and well being (evaluated by visual analogic scale-VAS) and general health status were considered secondary outcomes.

Results: All outcomes recorded showed significant improvements in both groups; however, the change of MEP (+34.2 mmHg, P < 0.001 and +26.1%, P < 0.001 for absolute and % of predicted, resp.) was significantly higher in active group. Also VAS dyspnoea improved faster and more significantly (P < 0.05) at day 12, and 14 in active group when compared with control. The drop-out rate was 6%, without differences between groups. Conclusions. In patients recovering from recent CTS, specific EMT by Respilift is feasible and effective. This trial is registered with ClinicalTrials.gov NCT01510275.

Figures

Figure 1
Figure 1
Study flow diagram. Study measures collected by demographic data (a), pletismography (b), arterial gas analysis (c), respiratory muscle performance (d), 6 min walking test (e), chronic MRC dyspnoea scale (f), health status-SF 36 (g), and patient-related symptoms (dyspnoea, thoracic pain, and well being) (h).
Figure 2
Figure 2
Representative patient using the combined devices Respivol and Respilift.
Figure 3
Figure 3
Treatment difference (active versus control group) in the primary study outcome evaluated at day 8 and day 14. MEP: maximal expiratory pressure. *P < 0.05; **P < 0.001.
Figure 4
Figure 4
Trend of symptoms reported by VAS score. VAS: visual analogic scale. ∗,∗∗P < 0.05 and P < 0.001 between groups at the same time, respectively.

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