Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-26 @ 2:27 PM
Study NCT ID:
NCT06335992
Status:
RECRUITING
Last Update Posted:
2025-08-19
First Post:
2024-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tissue Regeneration in Patients With Chronic Obstructive Pulmonary Disease After an Exercise Intervention.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2024-03-07', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary Function', 'timeFrame': 'Baseline, post intervention at 12 wks', 'description': 'FEV1 (Forced Expiratory volume in one second)'}], 'secondaryOutcomes': [{'measure': 'Physical capacity', 'timeFrame': 'Baseline, post intervention at 12 wks', 'description': '6MWD (six-minute walk distance), longer distance = better health'}, {'measure': 'Inflammation markers', 'timeFrame': 'Baseline, post intervention at 12 wks', 'description': 'Biomarkers (eg. C reactive protein, Interleukin-6)'}, {'measure': 'Level of emphysema', 'timeFrame': 'Baseline, post intervention at 12 wks', 'description': 'HRCT, (high-resolution computed tomography), AiDA (Air space dimension assessment)'}, {'measure': 'Maximal physical capacity ( Wmax)', 'timeFrame': 'Baseline, post intervention at 12 wks', 'description': 'Maximal watt during incremental cardiopulmonary exercise test'}, {'measure': 'COPD Assessment Test (CAT)', 'timeFrame': 'Baseline, post intervention at 12 wks', 'description': 'Health status, Score 1-40, lower score = better health'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic obstructive pulmonary disease', 'Exercise', 'Regeneration'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '41388411', 'type': 'DERIVED', 'citation': 'Larsson 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. doi: 10.1186/s12931-025-03443-y. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nObjectives (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.\n\n(ii) Study the effects of exercise training on the pulmonary ventilation/perfusion ratio and quality of life.\n\n(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.\n\n(iv) Investigate in vitro cell behaviour and remodelling/regenerative processes altered in COPD patients upon exercise training (aim 1).', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Forced expiratory volume in one second (FEV1) 85-30 % of predicted post bronchodilator\n* Optimal medical treatment according to GOLD and the Swedish National Guidelines\n* Absence of other significant diseases that could contribute to physical exercise limitation\n* Non-smoking since at least one year\n* Free from exacerbations (last 4 weeks)\n* BMI = 18- 35\n\nExclusion Criteria:\n\n* Regular participation in adjusted/specially designed exercise sessions\n* Unstable cardiovascular or pulmonary disease\n* Smoking\n* Any other criteria that at the discretion of the investigator prevent the study subject from participating in an exercise-training program'}, 'identificationModule': {'nctId': 'NCT06335992', 'acronym': 'T-Rex', 'briefTitle': 'Tissue Regeneration in Patients With Chronic Obstructive Pulmonary Disease After an Exercise Intervention.', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Activation of Regenerative Pathways by Exercise Training in Patients With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'Dnr 2022-00831-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': 'The exercise training protocol to be used in this study:\n\nSupervised exercise training (aerobic- and muscle strengthening exercise): 2 times a week for 12 weeks.\n\n* 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.\n* 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.\n\nExercise training at home: once a week for 12 weeks.', 'interventionNames': ['Other: Exercise regime']}], 'interventions': [{'name': 'Exercise regime', 'type': 'OTHER', 'description': 'Exercise', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lund', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Gunilla Westergren Thorsson, Phd', 'role': 'CONTACT', 'email': 'gunilla.westergren-thorsson@med.lu.se', 'phone': '+4646222 00 00'}, {'name': 'Caroline Ms Larsson, Phd', 'role': 'CONTACT', 'email': 'caroline.larsson@med.lu.se', 'phone': '+46736673026'}], 'facility': 'Lund University', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Uppsala', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Margareta Mrs Emtner, Phd', 'role': 'CONTACT', 'email': 'margareta.emtner@medsci.uu.se', 'phone': '+46737594481'}, {'name': 'Christer Mr Janson, Phd', 'role': 'CONTACT', 'email': 'christer.janson@medsci.uu.se', 'phone': '+46186114115'}], 'facility': 'Uppsala University', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lund University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Margareta Emtner', 'investigatorAffiliation': 'Uppsala University'}}}}