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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Respiratory muscle force: Maximal inspiratory pressure - MIP
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Subterranean, pulmonary rehabilitation
Pulmonary rehabilitation in the underground salt chambers of the 'Wieliczka' Salt Mine Health Resort
Intervention: Subterranean, pulmonary rehabilitation (Other)
Outcomes
Primary Outcomes
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.
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.
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.
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.
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
- FEV₁(2 weeks)
- FVC(2 weeks)
- PEF(2 weeks)
- Bronchodilator Reversibility (BDR) Test(2 weeks)
- Resting tongue posture(2 weeks)
- 3-Day Food Diary(up to 18 months)