Pulmonary Rehabilitation in Salt Chambers for Patients With COPD
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease)
- Registration Number
- NCT07122544
- Lead Sponsor
- University School of Physical Education, Krakow, Poland
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in exercise tolerance (ISWT distance) Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108) 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.
Change in quality of life (SGRQ-C total score) Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108) St. George's Respiratory Questionnaire version COPD (SGRQ-C) measures disease-specific quality of life.
- Secondary Outcome Measures
Name Time Method Change in Chest Mobility Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108) Measured using thoracic expansion assessment during respiration.
Change in Respiratory Muscle Strength Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108) Respiratory Muscle Strength: Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP)
Change in Muscle Strength Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108) Assessed with the 30-Second Chair Stand Test (30sCST), handgrip dynamometry, and deadlift strength test.
Thigh circumference Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108) Circumferential measurement of both thighs at their widest point with a tailor's tape measure.
Change in COPD Symptoms Severity Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108) Evaluated using the COPD Assessment Test (CAT).
Change in Dyspnea Severity Baseline (Day 1), Post-intervention (Day 18), 3 months follow-up (Day 108) Measured using the Modified Medical Research Council (mMRC) Dyspnea Scale and Borg Dyspnea Scale.