Inspiratory Muscle Training in Lung Transplant Candidates and Implications on Early Post-Transplant Outcomes: A Pilot and Feasibility Multicenter Randomized Clinical Trial

What this Trial Is About

This research aims to evaluate inspiratory muscle training (IMT) in adults who are candidates for lung transplantation (LTx), focusing on its impact on recovery and post-transplant outcomes. Lung transplant recovery can be complicated by prolonged mechanical ventilation and long intensive care stays, which may cause diaphragm weakness and poorer health-related quality of life (HRQoL). The trial seeks to assess if pre-transplant IMT can improve respiratory muscle strength, reduce complications, and enhance early post-transplant recovery. Participants are randomly assigned to one of two groups. The IMT group will perform two daily sessions of 30 breaths each (lasting less than 5 minutes) at home or in-person, starting at 30% of their maximal inspiratory pressure (MIP) with weekly intensity increases up to 70% as tolerated. They will also engage in exercise training three times a week, including aerobic, resistance, and flexibility exercises, supervised by a physiotherapist. The control group will continue usual care with exercise training three times a week during the waitlist period. Both groups will use a respiratory endurance device to monitor progress. Throughout the study, participants will undergo regular assessments including respiratory muscle endurance, dyspnea severity, mood, HRQoL, physical activity, pulmonary function, and exercise capacity from baseline until up to 3 months after transplantation. Data on hospitalizations, mechanical ventilation duration, and post-transplant outcomes will be collected. Adherence, adverse events, and participant satisfaction with IMT will be monitored, with a total intervention period of up to 24 months and follow-up continuing for 3 months post-transplant.

Inspiratory Muscle Training in Lung Transplant Candidates