the ElderlyPRSC-FERPBRNCT06951633
Effects of Pulmonary Rehabilitation in Salt Chambers on Functional Efficiency, Respiratory Parameters, and Blood Rheology in Elderly With Respiratory Diseases.
A study testing Subterranean, pulmonary rehabilitation in people with the Elderly and Respiratory Disorders, run by University School of Physical Education, Krakow, Poland at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- the Elderly, Respiratory Disorders
- What is being tested?
- Subterranean, pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 sitePoland
- Study dates
- 4 Apr 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Health Resort 'Wieliczka' Salt Mine in Wieliczka
Wieliczka, Wieliczka, 32-020
Magdalena Kostrzon, PhD, +48602713143, magdalena.kostrzon@kopalnia.pl
Marek Koprowski, PhD, +48604884364, marek.koprowski@kopalnia.pl
About this study
Official 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
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.
Read the 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.
- Conditions
- the Elderly, Respiratory Disorders
- Being tested
- Subterranean, pulmonary rehabilitation
- Keywords
- Pulmonary function, speleotherapy, blood tests, 6MWT, chest
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subterranean, pulmonary rehabilitationOther
Pulmonary rehabilitation in the underground Health Resort of the 'Wieliczka' Salt Mine
| Study group | Role | What they receive |
|---|---|---|
| Subterranean, pulmonary rehabilitation | Other | Pulmonary rehabilitation in the underground salt chambers of the 'Wieliczka' Salt Mine Health Resort Receives: Other: Subterranean, pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle force: Maximal inspiratory pressure - MIP
This test involves wearing a nose peg and inhaling through a tube, performed in three trials.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 18 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start4 Apr 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Prospective, Controlled, Crossover Study.
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University School of Physical Education, Krakow, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylwia Mętel, PhD, Study director, University of Physicsl Culture in Krakow, Poland al. Jana Pawła II 78, 31-571 Kraków
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951633
- Sponsor's protocol ID
- 29/RID/2025
- Other IDs
- No. 022/ RID/SP/0027/2024/01
- Acronym
- PRSC-FERPBR
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06951633
- Acronym / sponsor ID
- PRSC-FERPBR / 29/RID/2025
- Conditions
- the Elderly, Respiratory Disorders
- Keywords
- Pulmonary function, speleotherapy, blood tests, 6MWT, chest
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- University School of Physical Education, Krakow, PolandUniversity, hospital or other
- Study start
- 4 Apr 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Prospective, Controlled, Crossover Study.
| Arm | Type | Receives |
|---|---|---|
| Subterranean, pulmonary rehabilitation | Other | Other: Subterranean, pulmonary rehabilitationPulmonary rehabilitation in the underground salt chambers of the 'Wieliczka' Salt Mine Health Resort |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subterranean, pulmonary rehabilitationPulmonary rehabilitation in the underground Health Resort of the 'Wieliczka' Salt Mine | Other | Subterranean, pulmonary rehabilitation |
Primary outcome
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.
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.
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.
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.
6 secondary outcomes
FEV₁
Time frame: 2 weeks
FVC
Time frame: 2 weeks
PEF
Time frame: 2 weeks
Bronchodilator Reversibility (BDR) Test
Time frame: 2 weeks
Resting tongue posture
Time frame: 2 weeks
3-Day Food Diary
Time frame: up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sylwia Mętel, PhD study director
University of Physicsl Culture in Krakow, Poland al. Jana Pawła II 78, 31-571 Kraków
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subterranean, pulmonary rehabilitation in people with the Elderly and Respiratory Disorders, run by University School of Physical Education, Krakow, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylwia Mętel, PhD (+48606480472, sylwia.metel@awf.krakow.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory muscle force: Maximal inspiratory pressure - MIP (time frame: up to 18 months). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.