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

High-intensity exercise tested for COPD patients before lung surgery

NCT: NCT07343375 · Status: ENROLLING BY INVITATION · Phase: N/A · Sponsor: Rigshospitalet, Denmark · Started: 2026-04 · Est. Completion: 2029-12

Plain English Summary

Effect of High-intensity Interval Training on the Lung in Patients With COPD Referred for Lung Volume Reduction Surgery: The PREGENERATE Trial is a Not Applicable clinical trial sponsored by Rigshospitalet, Denmark studying COPD (Chronic Obstructive Pulmonary Disease). This trial tests if a specific exercise program can improve lung health in people with severe COPD. It is for individuals with COPD who are scheduled for lung volume reduction surgery. Participants will be randomly assigned to either a high-intensity exercise program or a control group. The alternative is standard care without the specific exercise program. The trial aims to enroll 24 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are a man or woman with emphysematous COPD referred for lung volume reduction surgery. You cannot join if you have symptoms of heart disease, heart failure, or cannot understand or complete the exercise. You also cannot join if you have leg pain when walking, are currently sick, have cancer, are pregnant, or have unstable heart rhythm issues. Certain kidney or liver problems, or abnormal blood test results for liver or kidney function, will also exclude you. This trial is studying COPD (Chronic Obstructive Pulmonary Disease), so participants generally need a confirmed diagnosis.

What They're Measuring

The study will look at changes in proteins within the lung tissue to see if the exercise program has a measurable effect on the lung's composition. The specific primary outcome measures are: Differential protein composition (At surgery). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it explores if intense exercise can help regenerate lung tissue in COPD patients, potentially improving outcomes after surgery and changing how we view COPD treatment. This research targets COPD (Chronic Obstructive Pulmonary Disease), where improved treatment options are needed.

Investor Insight

This trial investigates a novel pre-surgical intervention for COPD, a large patient population, with potential to improve surgical outcomes and reduce healthcare costs, though it is early phase and fo

Is This Trial Right for Me?

Ask your doctor if this high-intensity exercise program is safe for you before and after surgery. Participation involves being randomly assigned to either the exercise group or a control group, with regular assessments before and after the intervention. The exercise program involves specific high-intensity intervals, with options for different protocols based on participant comfort. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion criteria

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

Exclusion criteria

* 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

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07343375?

NCT07343375 is a Not Applicable INTERVENTIONAL study titled "Effect of High-intensity Interval Training on the Lung in Patients With COPD Referred for Lung Volume Reduction Surgery: The PREGENERATE Trial." It is currently enrolling by invitation and is sponsored by Rigshospitalet, Denmark. The trial targets enrollment of 24 participants.

What conditions does NCT07343375 study?

This trial investigates treatments for COPD (Chronic Obstructive Pulmonary Disease). The primary condition under study is COPD (Chronic Obstructive Pulmonary Disease).

What treatments are being tested in NCT07343375?

The interventions being studied include: 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 sho

What does Not Applicable mean for NCT07343375?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT07343375?

This trial is currently "Enrolling by Invitation." It started on 2026-04. The estimated completion date is 2029-12.

Who is sponsoring NCT07343375?

NCT07343375 is sponsored by Rigshospitalet, Denmark. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07343375?

The trial aims to enroll 24 participants. The trial status is enrolling by invitation.

How is NCT07343375 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT07343375?

The primary outcome measures are: Differential protein composition (At surgery). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07343375 being conducted?

This trial is being conducted at 1 site, including Copenhagen (Denmark).

Where can I find official information about NCT07343375?

The official record for NCT07343375 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07343375. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07343375 testing in simple terms?

This trial tests if a specific exercise program can improve lung health in people with severe COPD. It is for individuals with COPD who are scheduled for lung volume reduction surgery.

Why is this trial significant?

This trial matters because it explores if intense exercise can help regenerate lung tissue in COPD patients, potentially improving outcomes after surgery and changing how we view COPD treatment.

What are the potential risks of participating in NCT07343375?

The main risks are related to the high-intensity exercise itself, which could cause discomfort or strain. Potential side effects include symptoms of heart strain or exacerbation of COPD symptoms if not properly monitored. There's also a risk of not being able to complete or tolerate the exercise program. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07343375?

Ask your doctor if this high-intensity exercise program is safe for you before and after surgery. Participation involves being randomly assigned to either the exercise group or a control group, with regular assessments before and after the intervention. The exercise program involves specific high-intensity intervals, with options for different protocols based on participant comfort. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07343375 signal from an investment perspective?

This trial investigates a novel pre-surgical intervention for COPD, a large patient population, with potential to improve surgical outcomes and reduce healthcare costs, though it is early phase and fo This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participants will be randomly assigned to either a high-intensity exercise program or a control group. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.