Chronic Obstructive Pulmonary DiseaseT-RexNCT06335992
Tissue Regeneration in Patients With Chronic Obstructive Pulmonary Disease After an Exercise Intervention.
A study testing Exercise regime in people with Chronic Obstructive Pulmonary Disease, run by Uppsala University at 2 sites in Sweden.
Trial summary
The main objective of this project is to identify mechanisms for lung regeneration in patients with COPD induced by exercise training. The hypothesis is that adjusted exercise training improves disease outcome in these patients by decrease remodelling processes linked to oxidative stress, inflammatory and/or… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Exercise regime
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Sep 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Forced expiratory volume in one second (FEV1) 85-30 % of predicted post bronchodilator
- Optimal medical treatment according to GOLD and the Swedish National Guidelines
- Absence of other significant diseases that could contribute to physical exercise limitation
- Non-smoking since at least one year
- Free from exacerbations (last 4 weeks)
- BMI = 18- 35
Who cannot join
- Regular participation in adjusted/specially designed exercise sessions
- Unstable cardiovascular or pulmonary disease
- Smoking
- Any other criteria that at the discretion of the investigator prevent the study subject from participating in an exercise-training program
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Lund University
Lund
Gunilla Westergren Thorsson, Phd, +4646222 00 00, gunilla.westergren-thorsson@med.lu.se
Caroline Ms Larsson, Phd, +46736673026, caroline.larsson@med.lu.se
- Recruiting
Uppsala University
Uppsala
Margareta Mrs Emtner, Phd, +46737594481, margareta.emtner@medsci.uu.se
Christer Mr Janson, Phd, +46186114115, christer.janson@medsci.uu.se
About this study
Official title: Activation of Regenerative Pathways by Exercise Training in Patients With Chronic Obstructive Pulmonary Disease
The main objective of this project is to identify mechanisms for lung regeneration in patients with COPD induced by exercise training. The hypothesis is that adjusted exercise training improves disease outcome in these patients by decrease remodelling processes linked to oxidative stress, inflammatory and/or immunological pathways in the lung. Along the way, the investigator also expect to identify (or validate) biomarkers mirroring systemic processes such as reduced inflammation and ameliorating the epithelial barrier in these patients. These events may additionally act as potential targets for interventions.
Objectives (i) Evaluate biomarkers for regenerative processes, matrix turnover, stem cell activity and inflammatory patterns in lung tissue biopsies, blood- and urine samples correlated to vital lung parameters and physical capacity, before and after attending an exercise-training program.
Read more
(ii) Study the effects of exercise training on the pulmonary ventilation/perfusion ratio and quality of life.
(iii) Evaluate the relation between pathophysiology in the lung evaluated by CT scan, and systemic response measured by muscle biopsies and biomarkers in blood/urine.
(iv) Investigate in vitro cell behaviour and remodelling/regenerative processes altered in COPD patients upon exercise training (aim 1).
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is an increasing worldwide health problem characterized by progressive destruction of lung tissue. In the shadow of the pandemic, COPD patients may suffer more severely from COVID-19 with worse prognosis and higher mortality rate. This may be due to common underlying risk factors such as smoking, cardiovascular disease and a sedative life style. To cope with the soaring burden on the health care system posed by the aftermath of the pandemic in the context of chronic diseases such as COPD, the importance of self-responsibility to increase quality of life is emerging. New guidelines from the 2020 GOLD Science Committee Report on COVID-19 and Chronic Obstructive Pulmonary Disease support exercise in the management of COPD and after COVID-19 infection, even during mild COVID-19 symptoms. However, little is known about the molecular alterations induced by exercise training and how to boost the body´s ability to halt disease progression in COPD.
The hypothesize is that adjusted exercise training increases the ability to cope with biological stress, which is increased in COPD due to i.e. chronic inflammation and a history of smoking, and may facilitate restoration of damaged tissue. In this proposal the anticipation is to link the effects of physical exercise to amelioration of vital lung parameters, physical strength including 6 min walk test, and quality of life, by evaluating biomarkers for stem cell activity, regeneration and inflammation in lung tissue biopsies and blood samples. This will also result in the recognition of pathways that are targetable for novel pharmaceuticals that could synergize with the training effect.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Exercise regime
- Keywords
- Chronic obstructive pulmonary disease, Exercise, Regeneration
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise regimeOther
Exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | The exercise training protocol to be used in this study:
Supervised exercise training (aerobic- and muscle strengthening exercise): 2 times a week for 12 weeks.
* Aerobic exercise with ergometer cycling for 30 min, at moderate intensity (60% Wpeak) individually adjusted to level 4-6 on the Borg category ratio-10 scale.
* Muscle strengthening exercise will consist of 8-12 strength exercises of the major upper and lower body muscle groups. Each exercise includes three sets with 8-12 repetitions.
Exercise training at home: once a week for 12 weeks. Receives: Other: Exercise regime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function
FEV1 (Forced Expiratory volume in one second)
Measured: Baseline, post intervention at 12 wks
Secondary outcomes (5)
Physical capacity
6MWD (six-minute walk distance), longer distance = better health
Measured: Baseline, post intervention at 12 wks
Inflammation markers
Biomarkers (eg. C reactive protein, Interleukin-6)
Measured: Baseline, post intervention at 12 wks
Level of emphysema
HRCT, (high-resolution computed tomography), AiDA (Air space dimension assessment)
Measured: Baseline, post intervention at 12 wks
Maximal physical capacity ( Wmax)
Maximal watt during incremental cardiopulmonary exercise test
Measured: Baseline, post intervention at 12 wks
COPD Assessment Test (CAT)
Health status, Score 1-40, lower score = better health
Measured: Baseline, post intervention at 12 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 Sep 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Principal investigator, Margareta Emtner, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335992
- Sponsor's protocol ID
- Dnr 2022-00831-01
- Acronym
- T-Rex
- Status last verified
- Aug 2025
- First submitted
- 7 Mar 2024
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cederberg A, Ohrneman H, Elowsson L, Tufvesson E, Larsson C, Falcones B, Karlsson L, Akbarshahi H, Ankerst J, Bjermer L, Palm A, Londahl J, Malinovschi A, Janson C, Emtner M, Westergren-Thorsson G. Improvement in peripheral airway function after a 12-week exercise intervention in COPD. Respir Res. 2026 Oct 12;27(1):394. doi: 10.1186/s12931-026-03933-7.
PubMed 42864666Larsson C, Elowsson L, Tufvesson E, Cederberg A, Ohrneman H, Falcones B, Karlsson L, Akbarshahi H, Ankerst J, Bjermer L, Palm A, Londahl J, Malinovschi A, Janson C, Emtner M, Westergen-Thorsson G. Activation of regenerative pathways by exercise intervention in subjects with chronic obstructive pulmonary disease - a study protocol. Respir Res. 2025 Dec 12;27(1):16. doi: 10.1186/s12931-025-03443-y.
PubMed 41388411
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activation of Regenerative Pathways by Exercise Training in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06335992
- Acronym / sponsor ID
- T-Rex / Dnr 2022-00831-01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, Exercise, Regeneration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this project is to identify mechanisms for lung regeneration in patients with COPD induced by exercise training. The hypothesis is that adjusted exercise training improves disease outcome in these patients by decrease remodelling processes linked to oxidative stress, inflammatory and/or immunological pathways in the lung. Along the way, the investigator also expect to identify (or validate) biomarkers mirroring systemic processes such as reduced inflammation and ameliorating the epithelial barrier in these patients. These events may additionally act as potential targets for interventions.
Objectives (i) Evaluate biomarkers for regenerative processes, matrix turnover, stem cell activity and inflammatory patterns in lung tissue biopsies, blood- and urine samples correlated to vital lung parameters and physical capacity, before and after attending an exercise-training program.
(ii) Study the effects of exercise training on the pulmonary ventilation/perfusion ratio and quality of life.
(iii) Evaluate the relation between pathophysiology in the lung evaluated by CT scan, and systemic response measured by muscle biopsies and biomarkers in blood/urine.
(iv) Investigate in vitro cell behaviour and remodelling/regenerative processes altered in COPD patients upon exercise training (aim 1).
Detailed description
Chronic obstructive pulmonary disease (COPD) is an increasing worldwide health problem characterized by progressive destruction of lung tissue. In the shadow of the pandemic, COPD patients may suffer more severely from COVID-19 with worse prognosis and higher mortality rate. This may be due to common underlying risk factors such as smoking, cardiovascular disease and a sedative life style. To cope with the soaring burden on the health care system posed by the aftermath of the pandemic in the context of chronic diseases such as COPD, the importance of self-responsibility to increase quality of life is emerging. New guidelines from the 2020 GOLD Science Committee Report on COVID-19 and Chronic Obstructive Pulmonary Disease support exercise in the management of COPD and after COVID-19 infection, even during mild COVID-19 symptoms. However, little is known about the molecular alterations induced by exercise training and how to boost the body´s ability to halt disease progression in COPD.
The hypothesize is that adjusted exercise training increases the ability to cope with biological stress, which is increased in COPD due to i.e. chronic inflammation and a history of smoking, and may facilitate restoration of damaged tissue. In this proposal the anticipation is to link the effects of physical exercise to amelioration of vital lung parameters, physical strength including 6 min walk test, and quality of life, by evaluating biomarkers for stem cell activity, regeneration and inflammation in lung tissue biopsies and blood samples. This will also result in the recognition of pathways that are targetable for novel pharmaceuticals that could synergize with the training effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Exercise regimeThe exercise training protocol to be used in this study: Supervised exercise training (aerobic- and muscle strengthening exercise): 2 times a week for 12 weeks. * Aerobic exercise with ergometer cycling for 30 min, at moderate intensity (60% Wpeak) individually adjusted to level 4-6 on the Borg category ratio-10 scale. * Muscle strengthening exercise will consist of 8-12 strength exercises of the major upper and lower body muscle groups. Each exercise includes three sets with 8-12 repetitions. Exercise training at home: once a week for 12 weeks. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Forced expiratory volume in one second (FEV1) 85-30 % of predicted post bronchodilator
- Optimal medical treatment according to GOLD and the Swedish National Guidelines
- Absence of other significant diseases that could contribute to physical exercise limitation
- Non-smoking since at least one year
- Free from exacerbations (last 4 weeks)
Key exclusion criteria (4 listed)
- Regular participation in adjusted/specially designed exercise sessions
- Unstable cardiovascular or pulmonary disease
- Smoking
- Any other criteria that at the discretion of the investigator prevent the study subject from participating in an exercise-training program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise regimeExercise | Other | Exercise |
Primary outcome
Pulmonary Function
Time frame: Baseline, post intervention at 12 wks
FEV1 (Forced Expiratory volume in one second)
5 secondary outcomes
Physical capacity
Time frame: Baseline, post intervention at 12 wks
Inflammation markers
Time frame: Baseline, post intervention at 12 wks
Level of emphysema
Time frame: Baseline, post intervention at 12 wks
Maximal physical capacity ( Wmax)
Time frame: Baseline, post intervention at 12 wks
COPD Assessment Test (CAT)
Time frame: Baseline, post intervention at 12 wks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Derived from this study: PubMed 42864666Cederberg A, Ohrneman H, Elowsson L, Tufvesson E, Larsson C, Falcones B, Karlsson L, Akbarshahi H, Ankerst J, Bjermer L, Palm A, Londahl J, Malinovschi A, Janson C, Emtner M, Westergren-Thorsson G. Improvement in peripheral airway function after a 12-week exercise intervention in COPD. Respir Res. 2026 Oct 12;27(1):394. doi: 10.1186/s12931-026-03933-7.
- Derived from this study: PubMed 41388411Larsson C, Elowsson L, Tufvesson E, Cederberg A, Ohrneman H, Falcones B, Karlsson L, Akbarshahi H, Ankerst J, Bjermer L, Palm A, Londahl J, Malinovschi A, Janson C, Emtner M, Westergen-Thorsson G. Activation of regenerative pathways by exercise intervention in subjects with chronic obstructive pulmonary disease - a study protocol. Respir Res. 2025 Dec 12;27(1):16. doi: 10.1186/s12931-025-03443-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise regime in people with Chronic Obstructive Pulmonary Disease, run by Uppsala University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function (time frame: Baseline, post intervention at 12 wks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06335992, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.