The impact of bronchoscopic lung volume reduction with endobronchial valves with or without pulmonary rehabilitation on symptoms of fatigue, anxiety and depression: a multicentre randomised controlled trial.

Background: Bronchoscopic lung volume reduction using one-way endobronchial valves (BLVR-EBV) improves exercise capacity and quality of life in patients with severe emphysema. However, its effect on symptoms of fatigue, anxiety and depression is unclear. Furthermore, whether the combination of pulmonary rehabilitation (PR) and BLVR-EBV yields additional impact on these symptoms remains unknown. We hypothesised that BLVR-EBV would reduce symptoms of fatigue, anxiety and depression, and that the combination of BLVR-EBV with PR would lead to additional reduction when compared to BLVR-EBV alone.

Methods: The SoLVE study (ClinicalTrials.gov: NCT03474471) was a prospective multicentre randomised controlled trial to examine the impact and optimal timing of PR on exercise physiology and patient-reported outcomes in patients receiving BLVR-EBV treatment. Subjects were randomised into three groups: PR before BLVR-EBV, PR after BLVR-EBV and BLVR-EBV alone. Fatigue severity was assessed using the Checklist Individual Strength fatigue subscale (CIS-Fatigue). The Hospital Anxiety and Depression Scale evaluated symptoms of anxiety (HADS-A) and depression (HADS-D).

Results: 97 participants were included. After the 6-month follow-up the overall mean change after BLVR-EBV with or without PR was -8.2±10.6 points on CIS-Fatigue, -2.2±2.9 points on HADS-A and -2.3±3.0 points on HADS-D (p<0.001). No significant differences were observed between groups for changes in CIS-Fatigue, HADS-A or HADS-D.

Conclusion: BLVR-EBV is an effective intervention to improve symptoms of fatigue, anxiety and depression. The combination of PR and BLVR-EBV did not result in additional improvement when compared to BLVR-EBV alone.