NCT06335992 Tissue Regeneration in Patients With Chronic Obstructive Pulmonary Disease After an Exercise Intervention.
| NCT ID | NCT06335992 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Uppsala University |
| Condition | Chronic Obstructive Pulmonary Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2022-09-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Frequently Asked Questions
Who can join the NCT06335992 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 85 Years, studying Chronic Obstructive Pulmonary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06335992 currently recruiting?
Yes, NCT06335992 is actively recruiting participants. Visit ClinicalTrials.gov or contact Uppsala University to inquire about joining.
Where is the NCT06335992 trial being conducted?
This trial is being conducted at Lund, Sweden, Uppsala, Sweden.
Who is sponsoring the NCT06335992 clinical trial?
NCT06335992 is sponsored by Uppsala University. The trial plans to enroll 80 participants.