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

NCT06951633 | Recruiting

• 2 other identifiers: 29/RID/2025No. 022/ RID/SP/0027/2024/01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

the Elderly; Respiratory Disorders

Keywords

Pulmonary function, speleotherapy, blood tests, 6MWT, chest

Outcome Measures

Primary Outcomes (26)

• 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 Outcomes (6)

• FEV₁

  2 weeks

• FVC

  2 weeks

• PEF

  2 weeks

• Bronchodilator Reversibility (BDR) Test

  2 weeks

• Resting tongue posture

  2 weeks

Study Arms (1)

Subterranean, pulmonary rehabilitation

OTHER

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

Other: Subterranean, pulmonary rehabilitation

Interventions

Subterranean, pulmonary rehabilitation OTHER

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

Subterranean, pulmonary rehabilitation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University School of Physical Education, Krakow, Poland: lead

Study Sites (1)

Health Resort 'Wieliczka' Salt Mine in Wieliczka

Wieliczka, Wieliczka, 32-020, Poland

RECRUITING

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Sylwia Mętel, PhD

  University of Physicsl Culture in Krakow, Poland al. Jana Pawła II 78, 31-571 Kraków

  STUDY DIRECTOR

Central Study Contacts

Sylwia Mętel, PhD

CONTACT

+48606480472; sylwia.metel@awf.krakow.pl

Magdalena Kostrzon, PhD

CONTACT

+48602713143; magdalena.kostrzon@kopalnia.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Prospective, Controlled, Crossover Study.

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 30, 2025
• Study Start: April 4, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)