Pulmonary Rehabilitation in Salt Chambers for Patients With COPD

Official title

The Impact of Pulmonary Rehabilitation Conducted in Therapeutic Salt Chambers on the Clinical Status of Patients With Chronic Obstructive Pulmonary Disease (COPD)

Overview

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.

Interventions

• Behavioral Therapeutic stay in subterranean sanatorium chambers (microclimate therapy)
  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.
• Behavioral Breathing exercises
  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.
• Behavioral General fitness 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.
• Behavioral Relaxation training
  30 minutes, once during the entire cycle. Relaxation training will include rest in a seated position, with dimmed lighting and calming music.
• Behavioral Health education
  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.

Primary outcome measures

• Change in exercise tolerance (ISWT distance) [Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)]
• Change in quality of life (SGRQ-C total score) [Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)]

Secondary outcome measures (6)

• Change in Respiratory Muscle Strength [Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)]
• Change in Chest Mobility [Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)]
• Change in COPD Symptoms Severity [Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)]
• Change in Dyspnea Severity [Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)]
• Change in Muscle Strength [Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)]
• Thigh circumference [Time frame: Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Poland · 1 center

• AKF Kraków — Krakow

Identifiers

NCT: NCT07122544 · 169/MN/SD/2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗