An interventional study of Therapeutic stay in subterranean sanatorium chambers (microclimate therapy) and Breathing exercises in COPD (Chronic Obstructive Pulmonary Disease), sponsored by University School of Physical Education, Krakow, Poland. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by University School of Physical Education, Krakow, Poland · Not applicable, Interventional, and Supportive care
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's planned enrollment of 80 is above the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →University School of Physical Education, Krakow, Poland is the lead sponsor of 21 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Participants undergo a 16-day pulmonary rehabilitation program conducted in therapeutic salt chambers. The intervention includes general fitness, respiratory and relaxation exercises, health education. Conducted under supervision of a multidisciplinary team (physiotherapist, nurse, dietitian, physician). Sessions take place in the underground salt chambers of the "Wessel" complex (Salt Mine 'Wieliczka', Wieliczka, Poland).
Behavioral: Therapeutic stay in subterranean sanatorium chambers (microclimate therapy) · Behavioral: Breathing exercises · Behavioral: General fitness exercises · Behavioral: Relaxation training · Behavioral: Health education
Participants undergo the same 16-day pulmonary rehabilitation program as in Arm 1, but conducted in standard surface conditions without exposure to salt chamber microclimate.
Behavioral: Breathing exercises · Behavioral: General fitness exercises · Behavioral: Relaxation training · Behavioral: Health education
Participants attend daily 180-minutes passive sessions in therapeutic salt chambers for 16 days, without any physical exercise component.
Behavioral: Therapeutic stay in subterranean sanatorium chambers (microclimate therapy) · Behavioral: Health education
Participants receive printed materials and general health education related to COPD management. No supervised exercise or microclimatic exposure is included.
Behavioral: Health education
Characteristics of the underground environment in the Wieliczka sanatorium chambers: Stable climatic conditions: relative humidity ranging from 60-75%, temperature between 12.9-14.5°C; High chemical and biological air purity; Mineral content in the air: 2.7-8.1 mg/m³, consisting mainly of chloride, sodium, potassium, calcium, and fluoride ions; Air ionization: 1,200-4,700 aeroions/cm³ of air. Elevated atmospheric pressure: increased by approximately 16-20 mmHg compared to surface conditions.
30 minutes daily. Breathing exercises will include active respiratory exercises, drainage and effective coughing techniques, resistance training of the respiratory muscles, chest mobilization and relaxation exercises, breathing through pursed lips, as well as short and prolonged exhalation exercises.
30 minutes daily. General conditioning exercises will incorporate components aimed at improving overall aerobic capacity (e.g., walking-based activities, dance routines, step exercises), flexibility and coordination (e.g., stretching and balance exercises), and strength (e.g., exercises using resistance bands or dumbbells). The training will be conducted in interval, circuit, and free-form formats. Resistance levels will be individually adjusted to the patient's capacity.
30 minutes, once during the entire cycle. Relaxation training will include rest in a seated position, with dimmed lighting and calming music.
Educational materials in printed form for distribution covering the following topics: COPD - information about the disease; Breathing exercises and bronchial hygiene; Benefits of physical activity, including examples of exercises that can be performed at home.
Change in exercise tolerance (ISWT distance)
Incremental Shuttle Walk Test (ISWT) used to assess functional exercise tolerance in COPD patients. Measured as distance walked in meters. Evaluates change from baseline to post-intervention and at 3-month follow-up to assess immediate and sustained effects of rehabilitation.
Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
Change in quality of life (SGRQ-C total score)
St. George's Respiratory Questionnaire version COPD (SGRQ-C) measures disease-specific quality of life.
Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
Change in Respiratory Muscle Strength
Respiratory Muscle Strength: Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP)
Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
Change in Chest Mobility
Measured using thoracic expansion assessment during respiration.
Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
Change in COPD Symptoms Severity
Evaluated using the COPD Assessment Test (CAT).
Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
Change in Dyspnea Severity
Measured using the Modified Medical Research Council (mMRC) Dyspnea Scale and Borg Dyspnea Scale.
Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
Change in Muscle Strength
Assessed with the 30-Second Chair Stand Test (30sCST), handgrip dynamometry, and deadlift strength test.
Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
Thigh circumference
Circumferential measurement of both thighs at their widest point with a tailor's tape measure.
Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)
BODE Index
Multidimensional index including BMI, airflow obstruction (FEV1), dyspnea (mMRC), and exercise capacity (the result of the Incremental Shuttle Walk Test (ISWT) will be converted to an estimated equivalent distance of the 6-Minute Walk Test (6MWT) using established predictive formulas). In this study, the BODE index will be calculated only at baseline using data collected on Day 1. It will not be reassessed during follow-up visits because spirometry (FEV₁ measurement) will not be repeated after baseline.
Time frame: Baseline (Day 1 only)
Post-Bronchodilator Spirometry
A single spirometry with bronchodilator reversibility testing will be performed at baseline according to American Thoracic Society (ATS) and European Respiratory Society (ERS) standards. Spirometry will be performed only once during the study and will not be repeated at any subsequent visits. Parameters recorded: FEV₁ (Forced Expiratory Volume in 1 second) - liters and % predicted FVC (Forced Vital Capacity) - liters and % predicted FEV₁/FVC ratio Post-bronchodilator values will be used exclusively for participant eligibility assessment according to GOLD 2025 criteria.
Time frame: Baseline (Day 1 only)
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Pulmonary Disease, Chronic Obstructive→
University School of Physical Education, Krakow, Poland