NCT07122544 Pulmonary Rehabilitation in Salt Chambers for Patients With COPD
| NCT ID | NCT07122544 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University School of Physical Education, Krakow, Poland |
| Condition | COPD (Chronic Obstructive Pulmonary Disease) |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
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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 2025-09-01 with a primary completion date of 2027-01-01.
⚠ 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
Title: The Impact of Pulmonary Rehabilitation Conducted in Therapeutic Salt Chambers on the Clinical Condition of Patients with Chronic Obstructive Pulmonary Disease Background and Rationale: Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory disorder that significantly reduces patients' quality of life and functional capacity. In the search for supportive therapeutic strategies, there is growing interest in unconventional therapeutic environments such as therapeutic salt chambers. The underground climate of the "Wieliczka" Salt Mine in Poland - characterized by humidity 60-75%, temperature 12.9-14.5°C, high air purity and ionization - has shown therapeutic potential. However, the clinical effects of pulmonary rehabilitation conducted in such an environment in COPD patients remain insufficiently documented. Study Objective: To evaluate the effect of pulmonary rehabilitation and climatic therapy conducted in underground salt chambers on the clinical condition of patients with stable COPD. Research Question: Does pulmonary rehabilitation conducted in a subterranean salt mine environment offer measurable clinical benefits compared to standard surface-based rehabilitation? Study Design and Methods: This is a randomized, controlled, four-arm interventional study including 80 adult patients with a confirmed diagnosis of COPD according to the GOLD 2025 criteria. Participants will be randomly assigned to one of four groups: Group A: Pulmonary rehabilitation in underground therapeutic salt chambers (physical training + microclimate exposure). Group B: Pulmonary rehabilitation in a surface-level gymnasium (physical training without microclimate exposure). Group C: Passive stay in underground salt chambers (microclimate exposure without physical training). Group D: Health education only (control group, surface level). The intervention program consists of 16 consecutive working days of 3-hour daily sessions. The content of the rehabilitation varies depending on the assigned group and includes general conditioning exercises, respiratory exercises, relaxation training, and health education. Outcome Measures and Assessment Tools: Clinical assessments will be conducted at three time points: prior to the intervention (T0), immediately after the intervention (T1), and at a 3-month follow-up (T2 - for Groups A and B only). The monitored variables include: Exercise Tolerance: Incremental Shuttle Walk Test (ISWT) Health-Related Quality of Life: St. George's Respiratory Questionnaire COPD Symptoms and Risk Indexes: COPD Assessment Test (CAT), BODE Index Muscle Strength: Deadlift test, hand dynamometer, 30-second Chair Stand Test Respiratory Muscle Strength: Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) Body Composition: Bioelectrical Impedance Analysis (BIA) Dyspnea Scales: Borg Scale, modified Medical Research Council (mMRC) scale Chest Mobility: Measuring tape assessment The study is designed to evaluate both the immediate and long-term effects of different pulmonary rehabilitation models on clinical outcomes in COPD patients, with a focus on whether the underground environment enhances rehabilitation efficacy.
Eligibility Criteria
Inclusion Criteria: * COPD diagnosis confirmed by a pulmonology specialist according to the 2025 GOLD guidelines. * FEV1 ≥ 30% of the predicted value. * FEV1/FVC \< 0.7 after bronchodilator administration in spirometry. * Negative bronchodilator reversibility test. * Voluntary written consent to participate in the study. Exclusion Criteria: * COPD exacerbation. * Active cancer or a history of cancer within the past five years. * Musculoskeletal disorders preventing independent movement and participation in exercise tests and training included in the study protocol. * Recent (within six months) surgical procedure or trauma to the chest, abdomen, skull, brain, or eye area. * Severe valvular heart disease. * Implanted cardioverter-defibrillator. * Diagnosed arrhythmias posing a risk of loss of consciousness. * Acute coronary artery disease. * Epilepsy. * Uncontrolled arterial hypertension despite medication. * Primary or secondary immunodeficiencies. * Respiratory failure requiring chronic or intermittent oxygen therapy. * Infectious diseases with fever during the experiment or within two weeks before the study. * Claustrophobia. * Pregnancy. * Simultaneous participation in another rehabilitation program. * Significant changes in pharmacological treatment during the study.
Frequently Asked Questions
Who can join the NCT07122544 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying COPD (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 NCT07122544 currently recruiting?
Yes, NCT07122544 is actively recruiting participants. Visit ClinicalTrials.gov or contact University School of Physical Education, Krakow, Poland to inquire about joining.
Where is the NCT07122544 trial being conducted?
This trial is being conducted at Krakow, Poland.
Who is sponsoring the NCT07122544 clinical trial?
NCT07122544 is sponsored by University School of Physical Education, Krakow, Poland. The trial plans to enroll 80 participants.
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