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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary Rehabilitation in Salt Chambers | Experimental | 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). |
|
| Surface Rehabilitation | Active Comparator | 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. |
|
| Passive Stay in Salt Chambers | Experimental | Participants attend daily 180-minutes passive sessions in therapeutic salt chambers for 16 days, without any physical exercise component. |
|
| Health education only | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic stay in subterranean sanatorium chambers (microclimate therapy) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Respiratory Muscle Strength | Respiratory Muscle Strength: Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) | Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108) |
| Change in Chest Mobility |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKF Kraków | Recruiting | Krakow | Małopolska | 30-009 | Poland |
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Participants receive printed materials and general health education related to COPD management. No supervised exercise or microclimatic exposure is included.
|
|
| Breathing exercises | Behavioral | 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. |
|
| General fitness exercises | Behavioral | 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. |
|
| Relaxation training | Behavioral | 30 minutes, once during the entire cycle. Relaxation training will include rest in a seated position, with dimmed lighting and calming music. |
|
| Health education | Behavioral | 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. |
|
Measured using thoracic expansion assessment during respiration.
| 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). | 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. | 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. | 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. | Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108) |
| 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. | Baseline (Day 1 only) |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| D012064 | Relaxation Therapy |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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