Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07122544

Pulmonary Rehabilitation in Salt Chambers for Patients With COPD

Led by University School of Physical Education, Krakow, Poland · Updated on 2025-11-26

80

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Pulmonary Rehabilitation in Salt Chambers for Patients With COPD

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • COPD diagnosis confirmed by a pulmonology specialist according to the 2025 GOLD guidelines
  • FEV1 63 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
Not Eligible

You will not qualify if you...

  • COPD exacerbation
  • Active cancer or history of cancer within the past five years
  • Musculoskeletal disorders preventing independent movement and participation in exercise tests and training
  • Recent (within six months) surgery or trauma to chest, abdomen, skull, brain, or eye area
  • Severe valvular heart disease
  • Implanted cardioverter-defibrillator
  • Diagnosed arrhythmias posing 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 or within two weeks before the study
  • Claustrophobia
  • Pregnancy
  • Simultaneous participation in another rehabilitation program
  • Significant changes in pharmacological treatment during the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

AKF Kraków

Krakow, Małopolska, Poland, 30-009

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

4

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