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. 2025 Aug 11;11(4):00892-2024.
doi: 10.1183/23120541.00892-2024. eCollection 2025 Jul.

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

Rein Posthuma  1   2   3 , Marieke C van der Molen  4   5 , Anouk W Vaes  1 , Jorine E Hartman  4   5 , Martijn A Spruit  1   2   3 , Dirk-Jan Slebos  4   5 , Lowie E G W Vanfleteren  6   7
Affiliations

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

Rein Posthuma et al. ERJ Open Res. .

Abstract

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.

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Conflict of interest statement

Conflict of interest: M.A. Spruit reports grants from Lung Foundation Netherlands, Stichting Astmabestrijding, AstraZeneca, Teva, Boehringer Ingelheim and Chiesi. D-J. Slebos reports grants from PulmonX Corp USA, Nuvaira USA, PulmAir USA, Apreo USA and FreeFlowMedical; consultancy fees from Nuvaira USA, MoreAir USA, Apreo USA and PulmonX USA; payment or honoraria for lectures, presentations, manuscript writing or educational events from PulmonX USA and Nuvaira USA; and support for attending meetings from PulmonX USA. L.E.G.W. Vanfleteren reports grants from the Swedish Heart Lung Foundation, Kamprad Stiftelse, AstraZeneca, Swedish government and country council ALF grant (ALFGBG-824371), and Vinnova; payment or honoraria for lectures, presentations, manuscript writing or educational events from AstraZeneca, GSK, Chiesi, PulmonX, Grifols and Novartis; support for attending meetings from the Menarini Foundation; and participation on a data safety monitoring board or advisory board with AstraZeneca. The remaining authors have nothing to disclose.

Figures

FIGURE 1
FIGURE 1
Distribution of patients stratified according to cut-offs scores for a) fatigue (Checklist Individual Strength (CIS)-Fatigue), b) anxiety (Hospital Anxiety and Depression Scale (HADS)-Anxiety) and c) depression (HADS-Depression) at baseline and after the 6-month follow-up in the overall study population. CIS-Fatigue: total scores <26, 27–35 and ≥36 points indicate, respectively, normal, mild and severe fatigue. HADS-Anxiety or HADS-Depression: scores of 0–7, 8–10 and 11–21 points indicate, respectively, no, possible and high probability of clinical meaningful symptoms.
FIGURE 2
FIGURE 2
Correlations between baseline score (Visit 1) and change at the 6-month follow-up for a) Checklist Individual Strength (CIS)-Fatigue, b) Hospital Anxiety and Depression Scale (HADS)-Anxiety and c) HADS-Depression.
FIGURE 3
FIGURE 3
Correlations between change (Δ) in residual volume (L) and change in a) Checklist Individual Strength (CIS)-Fatigue, b) Hospital Anxiety and Depression Scale (HADS)-Anxiety and c) HADS-Depression at the 6-month follow-up.
FIGURE 4
FIGURE 4
Distribution of patients stratified according to cut-off scores per treatment arm for a) fatigue (Checklist Individual Strength (CIS)-Fatigue), b) anxiety (Hospital Anxiety and Depression Scale (HADS)-Anxiety) and c) depression (HADS-Depression). CIS-Fatigue: total scores <26, 27–35 and ≥36 points indicate, respectively, normal, mild and severe fatigue. HADS-Anxiety or HADS-Depression: scores of 0–7, 8–10 and 11–21 points indicate, respectively, no, possible and high probability of clinical meaningful symptoms. PR: pulmonary rehabilitation; BLVR-EBV: bronchoscopic lung volume reduction using one-way endobronchial valves.
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