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

NCT07343375 | Enrolling By Invitation DMC

• 1 other identifier: H-25061713
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Outcome Measures

Primary Outcomes (1)

• Differential protein composition

  Differences in change in differential protein composition in distal lung tissue between HIIT and control group post-intervention using spatial multimodal proteomics.

  At surgery

Secondary Outcomes (17)

• Differential protein composition

  At surgery

• Lung tissue protein composition

  At surgery

• Serum protein profiles

  At surgery

• Tissue niche and cellular composition

  At surgery

• Translational regions

  At surgery

Other Outcomes (65)

• Tissue morphology

  At surgery

• Mechanotransduction pathways

  At surgery

• Mesenchymal stromal cells

  At surgery

Study Arms (2)

Exercise group

EXPERIMENTAL

The HIIT intervention group includes three supervised sessions per week over the period while on waitinglist for lung volumen reduction surgery. These will take place at either CFAS or at home and will be supervised

Behavioral: High Intensity interval training (HIIT)

Control group

NO INTERVENTION

Controls will be encouraged to maintain current exercise habits for the duration of the study.

Interventions

High Intensity interval training (HIIT) BEHAVIORAL

The HIIT intervention consist of 4 intervals with each lasting 4 minutes (4x4min). If a participant reports discomfort related to the length of the intervals or start to feel unmotivated by performing the same exercise, we will use another HIIT protocol: 10x1min. The 4x4min HIIT consists of a warm-up period of 10 minutes with a target heart rate at 60-70% of HRmax, followed by 4 HIIT intervals with a target HR ≥85%. The intervals are separated by three minutes of active rest, in which the HR should drop to 60% of maximum. Following this, a cool down period of three minutes at warm up intensity is performed. The 10x1min HIIT consists of a 10-minute warm-up period.The warm-up is followed by 10 intervals, each lasting 1 min at 100% of maximal workload, separated by three minutes of active rest, in which the HR should drop to 60% of maximum. Following the intervals, a cool down period of three minutes at warm up intensity is performed.

Exercise group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• Referred for lung volume reduction surgery at Rigshospitalet because of emphysematous COPD.

You may not qualify if:

• Symptoms of ischaemic heart disease
• Known heart failure
• Unable to complete or understand HIIT training
• Claudication
• Symptoms of acute disease within 2 weeks prior to the study
• Known malignant disease
• Pregnancy
• Unstable cardiac arrhythmic disease
• Renal or liver dysfunction
• Known chronic kidney or liver disease
• Elevated creatinine, urea, alanine transaminase (ALAT), aspartate transaminase (ASAT), bilirubin, basic phosphatases at blood test

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Lund University: collaborator

Study Sites (1)

Centre for Physical Activity Research, Copenhagen University Hospital

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DMSc, Professor

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 15, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 2, 2026

Record last verified: 2025-12

Locations

DK (1)