Effects of Pulmonary Rehabilitation in Salt Chambers on Functional Efficiency, Respiratory Parameters, and Blood Rheology in Elderly With Respiratory Diseases. (PRSC-FERPBR)

Functional Efficiency, Respiratory Parameters and Blood Rheological Tests in Elderly People With Respiratory Diseases Participating in Pulmonary Rehabilitation in Underground Salt Chambers - a Prospective Experimental Study, Controlled in a Crossover Design

The aim of the study is to assess the impact of the rehabilitation and treatment stay at the underground Health Resort of the 'Wieliczka' Salt Mine in Wieliczka on the functional capacity, respiratory parameters, and rheological properties of blood in elderly individuals with respiratory diseases.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Disorders; the Elderly
• Intervention / Treatment: Other: Subterranean, pulmonary rehabilitation

Detailed Description

The research project will involve patients aged 65 and older with chronic respiratory diseases. Based on controlled studies conducted at the Health Resort "Wieliczka" Salt Mine in Wieliczka, and assuming the project will be a prospective, experimental, controlled study with a crossover design, calculations were made for the primary variable under investigation (exercise tolerance). These calculations determined that 29 pairs of participants are needed to achieve a statistical power of 80% and a significance level of 5% (bilateral). To detect a mean difference between pairs of 58, assuming a standard deviation of 106 for these differences and accounting for a 10% loss of participants from observation, the required sample size was increased to 33 pairs. Given the crossover design, the study plans to include 33 patients.

Volunteers will undergo qualifying tests, measurements of functional fitness, respiratory indicators, and blood rheology tests 3 weeks prior to the start of the rehabilitation and therapeutic stay in the underground salt chambers (1st test). During the 3-week period before the rehabilitation, participants will not engage in any other form of therapeutic rehabilitation. Functional fitness, respiratory indicators, and blood rheology tests will be repeated before the start of the stay (2nd test), immediately after its completion (3rd test), and 3 months after its completion (4th follow-up test). Each day of the rehabilitation and therapeutic stay will include a 2.5-hour visit to the underground health resort under the supervision of a doctor, physiotherapist, and nurse, during which pulmonary rehabilitation will be implemented.

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sylwia Mętel, PhD; Phone Number: +48606480472; Email: sylwia.metel@awf.krakow.pl
• Study Contact Backup: Name: Magdalena Kostrzon, PhD; Phone Number: +48602713143; Email: magdalena.kostrzon@kopalnia.pl

Study Locations

• Poland
  • Wieliczka, Poland, 32-020
    • Recruiting
    • Health Resort 'Wieliczka' Salt Mine in Wieliczka
    • Contact: Magdalena Kostrzon, PhD; Phone Number: +48602713143; Email: magdalena.kostrzon@kopalnia.pl
    • Contact: Marek Koprowski, PhD; Phone Number: +48604884364; Email: marek.koprowski@kopalnia.pl
    • Contact: Sylwia Mętel, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• people aged 65 and older with chronic respiratory diseases in a stable period of the disease (without exacerbations), qualified to participate in a rehabilitation and treatment stay in the underground Health Resort 'Wieliczka' Salt Mine in Wieliczka,
• patients who gave informed, written consent to participate in the study.

Exclusion Criteria:

• patients with contraindications to subterraneotherapy and physical exercise,
• lack of written consent to participate in the study,
• deterioration of health during the implementation of the program.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Subterranean, pulmonary rehabilitation; Pulmonary rehabilitation in the underground salt chambers of the 'Wieliczka' Salt Mine Health Resort	Other: Subterranean, pulmonary rehabilitation; Pulmonary rehabilitation in the underground Health Resort of the 'Wieliczka' Salt Mine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory muscle force: Maximal inspiratory pressure - MIP	This test involves wearing a nose peg and inhaling through a tube, performed in three trials.	up to 18 months
Respiratory muscle force: Maximal expiratory pressure - MEP	This test involves wearing a nose peg and exhaling through a tube, performed in three trials.	up to 18 months
Respiratory muscle force: Sniff Nasal Inspiratory Pressure - SNIP	The test consists of separate inhalations through the left and right nostrils, performed in five trials per nostril.	up to 18 months
6-Minute Walk Test - 6MWT	The 6-Minute Walk Test (6MWT) is a standardized test used to assess functional exercise capacity. It measures the distance an individual can walk on a flat, hard surface in a period of six minutes	up to 18 months
The Aggregation Index (AI)	The Aggregation Index (AI), indicating the extent of red blood cell aggregation, is measured using the Lorrca Maxis (Laser-Assisted Optical Rotational Cell Analyzer) under standardized shear conditions. (AI) analyzed	up to 18 months
The half-time of total aggregation (T1/2)	The half-time of total aggregation (T1/2), which reflects the time required for red blood cells to aggregate to 50% of their maximum value, is assessed using the Lorrca Maxis (Laser-Assisted Optical Rotational Cell Analyzer). This test measures the aggregation kinetics of erythrocytes under controlled shear stress, providing a quantitative assessment of the aggregation process.	up to 18 months
The Elongation Index (EI)	The Elongation Index (EI), reflecting red blood cell deformability, is measured using the Lorrca Maxis (Laser-Assisted Optical Rotational Cell Analyzer), which evaluates the ability of erythrocytes to deform under varying shear stress.	up to 18 months
4- Meters Gait Speed Test - 4MGST	The 4-Meters Gait Speed Test (4MGST) is a simple, widely used assessment tool to measure an individual's walking speed over a short, fixed distance. It is primarily used to evaluate mobility and functional performance, especially in elderly individuals.	up to 18 months
Health Related Quality of Life - HRQoL withe the use of 15D questionnaire.	The 15D is a comprehensive, generic health-related quality of life (HRQoL) tool that measures an individual's overall health status. It includes 15 dimensions, covering aspects of physical, mental, and social well-being.Minimum Value: 0 (representing the worst possible health state) Maximum Value: 1 (representing the best possible health state). Higher Scores indicate better health-related quality of life, reflecting higher levels of functioning and well-being across the 15 dimensions.	up to 18 months
Chest mobility	The assessment of chest mobility involves evaluating the range of motion (ROM) and the expansion of the chest during inspiration and expiration, performed in three trials.	up to 18 months
Back scratch test	The patient is instructed to reach with his dominant hand behind his head, over the shoulder, as if trying to scratch the back of their neck. The fingers should be pointing downward toward the spine.The distance between the fingers (or whether they touch) is measured to assess the flexibility and range of motion of the shoulder and upper back.	up to 18 months
Interleukin IL 1b	Interleukin-1 beta (IL-1β) is a pro-inflammatory cytokine produced primarily by activated macrophages and monocytes. It plays a central role in the regulation of immune and inflammatory responses and is considered a key mediator in the pathophysiology of various chronic inflammatory, autoimmune, and infectious diseases.	up to 18 months
Interleukin IL-6	Interleukin-6 (IL-6) is a pleiotropic pro-inflammatory cytokine produced by various cell types, including macrophages, T cells, B cells, endothelial cells, fibroblasts, and skeletal muscle cells. It plays a key role in the regulation of immune responses, inflammation, hematopoiesis, and metabolism.	up to 18 months
TNF-alfa	Tumor Necrosis Factor alpha (TNF-α) is a key pro-inflammatory cytokine involved in the regulation of immune responses, inflammation, and apoptosis. It is produced primarily by activated macrophages, but also by T lymphocytes, natural killer (NK) cells, and other immune and non-immune cells in response to infection, injury, or immune stimulation.	up to 18 months
WBC [10⁹/l]	White Blood Cell Count - WBC [10⁹/l] Represents the number of leukocytes in one liter of blood. WBCs play a crucial role in immune defense. Elevated levels may indicate infection, inflammation, physiological stress, or hematologic malignancies. Decreased levels can be associated with bone marrow suppression or immunodeficiency.	up to 18 months
RBC [10¹²/l],	Red Blood Cell Count - RBC [10¹²/l] Indicates the number of erythrocytes per liter of blood. RBCs are responsible for oxygen transport. Decreased levels suggest anemia; elevated levels may indicate dehydration or polycythemia.	up to 18 months
HGB [g/dl]	Hemoglobin Concentration - HGB [g/dl] Measures the amount of hemoglobin in the blood. Hemoglobin is the oxygen-carrying protein in red blood cells. It is a key indicator of oxygen-carrying capacity and a primary marker for diagnosing anemia.	up to 18 months
HCT [%]	Hematocrit - HCT [%] Refers to the percentage of total blood volume occupied by red blood cells. Lower values are commonly seen in anemia; higher values may indicate dehydration or polycythemia.	up to 18 months
MCV [fl]	Mean Corpuscular Volume - MCV [fl] Reflects the average volume of individual erythrocytes. It helps to classify anemia as microcytic, normocytic, or macrocytic.	up to 18 months
MCH [pg]	Mean Corpuscular Hemoglobin -MCH [pg] Indicates the average amount of hemoglobin per red blood cell. It provides additional insight into the hemoglobin content in different types of anemia.	up to 18 months
MCHC [g/dl]	Mean Corpuscular Hemoglobin Concentration - MCHC [g/dl] Represents the average concentration of hemoglobin in erythrocytes. Decreased levels suggest hypochromia, commonly observed in iron deficiency anemia.	up to 18 months
PLT [109/l]	Platelet Count - PLT [10⁹/l] Determines the number of platelets in one liter of blood. Platelets are essential for blood clotting. Thrombocytopenia increases bleeding risk, while elevated platelet counts may indicate inflammation or a prothrombotic state.	up to 18 months
Reticulocytes {% or ‰]	Reticulocytes [% or ‰] Immature red blood cells that reflect bone marrow erythropoietic activity. Increased reticulocyte counts indicate active regeneration, commonly seen in response to anemia or blood loss.	up to 18 months
CRP [mg/l]	C-Reactive Protein - CRP [mg/l] An acute-phase protein produced by the liver in response to inflammation. Elevated CRP levels are a sensitive but non-specific marker of acute inflammation, infection, or tissue injury.	up to 18 months
Fibrinogen [g/l]	Fibrinogen A coagulation factor and acute-phase reactant synthesized in the liver. Increased fibrinogen levels are observed during inflammation, infection, or trauma and may contribute to a hypercoagulable state.	up to 18 months
ESR [mm/h]	Erythrocyte Sedimentation Rate - ESR [mm/h] A non-specific indicator of inflammation that measures the rate at which red blood cells settle in a vertical tube over one hour. Elevated ESR values are commonly found in infections, autoimmune diseases, and malignancies.	up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FEV₁	Forced Expiratory Volume in One Second [L] - FEV₁ FEV₁ represents the volume of air forcibly exhaled during the first second of a forced expiratory maneuver, starting from full lung inflation. It is a key parameter in the assessment of airway obstruction and is used in the diagnosis and monitoring of diseases such as chronic obstructive pulmonary disease (COPD) and asthma. Lower FEV₁ values indicate narrowing of the airways or reduced lung function.	2 weeks
FVC	Forced Vital Capacity [L] - FVC FVC is the total volume of air that can be forcibly exhaled after a full inspiration. It reflects the elastic properties of the lungs and chest wall. FVC is used in conjunction with FEV₁ to assess restrictive and obstructive ventilatory patterns. A reduced FVC may suggest lung restriction, while a low FEV₁/FVC ratio typically indicates airway obstruction.	2 weeks
PEF	Peak Expiratory Flow [L/min] - PEF PEF represents the maximum flow rate achieved during a forced expiratory maneuver. It is a simple and reproducible indicator of large airway function and is often used in asthma monitoring, bronchodilator response testing, and occupational lung health assessments. Reduced PEF may indicate airway narrowing, poor effort, or respiratory muscle weakness.	2 weeks
Bronchodilator Reversibility (BDR) Test	The bronchodilator reversibility test is performed to assess the responsiveness of the airways to bronchodilator medications, typically in patients suspected of having reversible airway obstruction, such as in asthma or chronic obstructive pulmonary disease (COPD). The test evaluates how spirometric values change following the administration of a bronchodilator (e.g., salbutamol or ipratropium), which relaxes smooth muscles and widens the airways.	2 weeks
Resting tongue posture	The resting tongue posture refers to the position of the tongue when the body is at rest, without any active movements such as speaking, chewing, or swallowing. It plays a crucial role in oral and facial development, as well as in maintaining proper function of the airway.	2 weeks
3-Day Food Diary	The primary purpose of the 3-Day Food Diary is to accurately record the types and quantities of food and beverages consumed over the course of three consecutive days. It helps to: Provide a snapshot of typical eating behaviors and meal patterns. Identify potential nutritional deficiencies or imbalances. Assess the relationship between diet and health outcomes in clinical studies	up to 18 months

Collaborators and Investigators

• Sponsor: University School of Physical Education, Krakow, Poland
• Investigators: Study Director: Sylwia Mętel, PhD, University of Physicsl Culture in Krakow, Poland al. Jana Pawła II 78, 31-571 Kraków

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Pulmonary function, speleotherapy, blood tests, 6MWT, chest
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders
• Other Study ID Numbers: 29/RID/2025; No. 022/ RID/SP/0027/2024/01 (Other Grant/Funding Number: Minister of Science and Higher Education)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No