Pulmonary Rehabilitation in Salt Chambers for Patients With COPD

NCT07122544 | Recruiting DMC

• 1 other identifier: 169/MN/SD/2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

speleotherapy

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (6)

• Change in Respiratory Muscle Strength

  Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)

• Change in Chest Mobility

  Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)

• Change in COPD Symptoms Severity

  Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)

• Change in Dyspnea Severity

  Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)

• Change in Muscle Strength

  Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108)

Other Outcomes (2)

• BODE Index

  Baseline (Day 1 only)

• Post-Bronchodilator Spirometry

  Baseline (Day 1 only)

Study Arms (4)

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).

Behavioral: Therapeutic stay in subterranean sanatorium chambers (microclimate therapy); Behavioral: Breathing exercises; Behavioral: General fitness exercises; Behavioral: Relaxation training; Behavioral: Health education

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.

Behavioral: Breathing exercises; Behavioral: General fitness exercises; Behavioral: Relaxation training; Behavioral: Health education

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.

Behavioral: Therapeutic stay in subterranean sanatorium chambers (microclimate therapy); Behavioral: Health education

Health education only

ACTIVE COMPARATOR

Participants receive printed materials and general health education related to COPD management. No supervised exercise or microclimatic exposure is included.

Behavioral: Health education

Interventions

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.

Passive Stay in Salt Chambers; Pulmonary Rehabilitation in Salt Chambers

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.

Pulmonary Rehabilitation in Salt Chambers; Surface Rehabilitation

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.

Pulmonary Rehabilitation in Salt Chambers; Surface Rehabilitation

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.

Pulmonary Rehabilitation in Salt Chambers; Surface Rehabilitation

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.

Health education only; Passive Stay in Salt Chambers; Pulmonary Rehabilitation in Salt Chambers; Surface Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University School of Physical Education, Krakow, Poland: lead

Study Sites (1)

AKF Kraków

Krakow, Małopolska, 30-009, Poland

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Breathing Exercises; Relaxation Therapy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 14, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: November 26, 2025

Record last verified: 2025-07

Locations

PL (1)