Clinical Trial

Effect of High-intensity Interval Training on the Lung in Patients With COPD Referred for Lung Volume Reduction Surgery: The PREGENERATE Trial

Study acronym: PREGENERATE
Enrolling by Invitation
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Summary
Patients with chronic obstructive lung disease (COPD) suffer from a progressive loss of lung function that leads to poor quality of life, and often invalidity and early death. Regular exercise can improve quality of life in these patients, but there is a lack in understanding the underlying mechanism of exercise-induced improvement in COPD and it is widely thought not to have any effect on the lung as such. In the present study, the investigators aim to investigate the impact of an extensive high-intensity interval training (HIIT)-based exercise scheme on the regenerative capacity of the lung in patients with COPD on waiting list for lung volume reduction surgery. Design: Prospective randomized controlled clinical trial. Intervention: 24 persons with COPD referred for lung volume reduction surgery will randomly be allocated (1:1) to prehabilitation with high intensity interval training (HIIT) or non-exercise control. Outcomes: The primary outcome is differences in change in differential protein composition in distal lung tissue between HIIT and control groups post-intervention using spatial multimodal proteomics. Furthermore, lung tissue mass, protein composition (mass spectrometry and spatial omics e.g. MACSima), pulmonary blood volume, blood protein profile (biomarkers), diffusion capacity at rest and during exercise, oxygen consumption tests, body composition scan, distal airspace radii and physical functional tests will be measured before and after the intervention. Perspective: This study may fundamentally change the view on the regenerative potential of the lungs in COPD.
Protocol Amendment History 1 change
critical Trial status changed: Not Yet Recruiting → Enrolling by Invitation 2026-04-03
Trial Details
NCT Number NCT07343375
Lead Sponsor Rigshospitalet, Denmark
Collaborators: Lund University
Conditions COPD (Chronic Obstructive Pulmonary Disease)
Enrollment 24 participants
Start Date 2026-04
Primary Completion 2029-01 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-02