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NCT Number: NCT06951633

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Subterranean, pulmonary rehabilitation

Other

Pulmonary rehabilitation in the underground Health Resort of the 'Wieliczka' Salt Mine

Primary outcomes

  1. Respiratory muscle force: Maximal inspiratory pressure - MIP

    Time frame: up to 18 months

    This test involves wearing a nose peg and inhaling through a tube, performed in three trials.

  2. Respiratory muscle force: Maximal expiratory pressure - MEP

    Time frame: up to 18 months

    This test involves wearing a nose peg and exhaling through a tube, performed in three trials.

  3. Respiratory muscle force: Sniff Nasal Inspiratory Pressure - SNIP

    Time frame: up to 18 months

    The test consists of separate inhalations through the left and right nostrils, performed in five trials per nostril.

  4. 6-Minute Walk Test - 6MWT

    Time frame: up to 18 months

    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

  5. The Aggregation Index (AI)

    Time frame: up to 18 months

    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

  6. The half-time of total aggregation (T1/2)

    Time frame: up to 18 months

    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.

  7. The Elongation Index (EI)

    Time frame: up to 18 months

    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.

  8. 4- Meters Gait Speed Test - 4MGST

    Time frame: up to 18 months

    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.

  9. Health Related Quality of Life - HRQoL withe the use of 15D questionnaire.

    Time frame: up to 18 months

    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.

  10. Chest mobility

    Time frame: up to 18 months

    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.

  11. Back scratch test

    Time frame: up to 18 months

    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.

  12. Interleukin IL 1b

    Time frame: up to 18 months

    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.

  13. Interleukin IL-6

    Time frame: up to 18 months

    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.

  14. TNF-alfa

    Time frame: up to 18 months

    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.

  15. WBC [10⁹/l]

    Time frame: up to 18 months

    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.

  16. RBC [10¹²/l],

    Time frame: up to 18 months

    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.

  17. HGB [g/dl]

    Time frame: up to 18 months

    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.

  18. HCT [%]

    Time frame: up to 18 months

    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.

  19. MCV [fl]

    Time frame: up to 18 months

    Mean Corpuscular Volume - MCV [fl]

    Reflects the average volume of individual erythrocytes. It helps to classify anemia as microcytic, normocytic, or macrocytic.

  20. MCH [pg]

    Time frame: up to 18 months

    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.

  21. MCHC [g/dl]

    Time frame: up to 18 months

    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.

  22. PLT [109/l]

    Time frame: up to 18 months

    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.

  23. Reticulocytes {% or ‰]

    Time frame: up to 18 months

    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.

  24. CRP [mg/l]

    Time frame: up to 18 months

    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.

  25. Fibrinogen [g/l]

    Time frame: up to 18 months

    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.

  26. ESR [mm/h]

    Time frame: up to 18 months

    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.

Secondary outcomes

  1. FEV₁

    Time frame: 2 weeks

    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. FVC

    Time frame: 2 weeks

    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.

  3. PEF

    Time frame: 2 weeks

    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.

  4. Bronchodilator Reversibility (BDR) Test

    Time frame: 2 weeks

    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.

  5. Resting tongue posture

    Time frame: 2 weeks

    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.

  6. 3-Day Food Diary

    Time frame: up to 18 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Magdalena Kostrzon, PhD

CONTACT

[email protected]

+48602713143

Sylwia Mętel, PhD

CONTACT

[email protected]

+48606480472

Sponsors and collaborators

Lead sponsor

University School of Physical Education, Krakow, Poland

Other

Registry information

Official study title

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

Acronym: PRSC-FERPBR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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