Pulmonary Rehabilitation in Salt Chambers for Patients With COPD
NCT07122544 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2025-11-26
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)
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.
Sponsors & Collaborators
-
University School of Physical Education, Krakow, Poland
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-01
- Primary Completion
- 2027-01-01
- Completion
- 2028-01-01
Countries
- Poland
Study Locations
More Related Trials
-
Impact of Feedback on Physical Activity and Health-related Outcomes During Pulmonary Rehabilitation in COPD
NCT02725931 ·Status: COMPLETED ·Phase: NA
-
Rehabilitation of Patients With Lung Chronic Obstructive Pulmonary Disease
NCT02468635 ·Status: UNKNOWN ·Phase: NA
-
Cardiovascular Effects of Pulmonary Rehabilitation in COPD
NCT03943030 ·Status: COMPLETED ·Phase: NA
-
Effects of Blood Flow Restriction Aerobic Exercise on Inflammation, Hypoxia, Exercise Capacity, and Lung Function in COPD
NCT07261293 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
The Impact of a Home-based Pulmonary Telerehabilitation Program in Acute Exacerbations of COPD
NCT03997513 ·Status: COMPLETED ·Phase: NA
-
Effects of Yoga on Clinical Impact and Psychosocial Aspects of COPD
NCT02539524 ·Status: COMPLETED ·Phase: NA
-
Long-term Physical Training in Chronic Obstructive Pulmonary Disease
NCT01537627 ·Status: UNKNOWN ·Phase: NA
-
Physical Activity Level of Patients With COPD During Pulmonary Rehabilitation
NCT04726384 ·Status: COMPLETED
-
Functional Status in COPD Patients After Exercise Rehabilitation Program
NCT06142266 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Long Term Effects of an Inpatient Pulmonary Rehabilitation Program in Patients With Pulmonary Fibrosis
NCT01772667 ·Status: COMPLETED ·Phase: NA
-
Respiratory Rehabilitation and Sleep Quality in COPD Patients
NCT06677268 ·Status: RECRUITING ·Phase: NA
-
Exercise in Health and Chronic Obstructive Pulmonary Disease
NCT02300064 ·Status: COMPLETED ·Phase: NA
-
Resting Heart Rate in Chronic Obstructive Pulmonary Disease
NCT04890080 ·Status: COMPLETED ·Phase: NA
-
Counseling During Pulmonary Rehabilitation
NCT02455206 ·Status: COMPLETED ·Phase: NA
-
Effects of Two Training Protocols in Patients With Chronic Obstructive Pulmonary Disease
NCT01691131 ·Status: COMPLETED ·Phase: NA
-
Short-course Out-patient Pulmonary Rehabilitation and COPD Exacerbations
NCT02471235 ·Status: COMPLETED ·Phase: NA
-
Virtual Pulmonary Rehabilitation Program for COPD Patients; a Pilot Study
NCT06915740 ·Status: RECRUITING ·Phase: NA
-
Effects of Pulmonary Rehabilitation on Respiratory Sounds in Patients With COPD
NCT02050711 ·Status: COMPLETED ·Phase: NA
-
Pulmonary Rehabilitation: Effects on Cognitive Functioning, Mood, Anxiety, and Quality of Life in Patients With COPD
NCT01682447 ·Status: COMPLETED ·Phase: NA
-
Comorbidity and Pulmonary Rehabilitation in COPD
NCT03319108 ·Status: COMPLETED ·Phase: NA
-
Impact of a Hospital Physical Therapy Program on Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT01295359 ·Status: UNKNOWN ·Phase: NA
-
Home-based Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
NCT04722224 ·Status: RECRUITING ·Phase: NA
-
Home-based Health Management of Chronic Obstructive Lung Disease (COPD) Patients
NCT02999685 ·Status: COMPLETED ·Phase: NA
-
Ambulatory Interdisciplinary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD)
NCT01195402 ·Status: COMPLETED ·Phase: NA
-
Cardio-pulmonary Rehabilitation and Sleep Quality
NCT04668599 ·Status: COMPLETED