NCT07122544Recruiting
Pulmonary Rehabilitation in Salt Chambers for Patients With COPD
The Impact of Pulmonary Rehabilitation Conducted in Therapeutic Salt Chambers on the Clinical Status of Patients With Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov · Last updated 26 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 30 Jul 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- University School of Physical Education, Krakow, Poland
- Diseases
- COPD
- NCT number
- NCT07122544
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 1 Sept 2025 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent (within six months) surgical procedure or trauma to the chest, abdomen, skull, brain, or eye area.
- Infectious diseases with fever during the experiment or within two weeks before the study.
Other illness
- 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.
- Severe valvular heart disease.
- Diagnosed arrhythmias posing a risk of loss of consciousness.
- Acute coronary artery disease.
- Epilepsy.
- Uncontrolled arterial hypertension despite medication.
- Respiratory failure requiring chronic or intermittent oxygen therapy.
Other
- COPD exacerbation.
- Implanted cardioverter-defibrillator.
- Primary or secondary immunodeficiencies.
- Claustrophobia.
- Pregnancy.
- Simultaneous participation in another rehabilitation program.
- Significant changes in pharmacological treatment during the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AKF Kraków Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.