Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-30 @ 9:48 PM
Study NCT ID:
NCT06951633
Status:
RECRUITING
Last Update Posted:
2025-04-30
First Post:
2025-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Pulmonary Rehabilitation in Salt Chambers on Functional Efficiency, Respiratory Parameters, and Blood Rheology in Elderly With Respiratory Diseases.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012120', 'term': 'Respiration Disorders'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A Prospective, Controlled, Crossover Study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-22', 'studyFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2025-04-22', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory muscle force: Maximal inspiratory pressure - MIP', 'timeFrame': 'up to 18 months', 'description': 'This test involves wearing a nose peg and inhaling through a tube, performed in three trials.'}, {'measure': 'Respiratory muscle force: Maximal expiratory pressure - MEP', 'timeFrame': 'up to 18 months', 'description': 'This test involves wearing a nose peg and exhaling through a tube, performed in three trials.'}, {'measure': 'Respiratory muscle force: Sniff Nasal Inspiratory Pressure - SNIP', 'timeFrame': 'up to 18 months', 'description': 'The test consists of separate inhalations through the left and right nostrils, performed in five trials per nostril.'}, {'measure': '6-Minute Walk Test - 6MWT', 'timeFrame': 'up to 18 months', 'description': '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'}, {'measure': 'The Aggregation Index (AI)', 'timeFrame': 'up to 18 months', 'description': '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.\n\n(AI) analyzed'}, {'measure': 'The half-time of total aggregation (T1/2)', 'timeFrame': 'up to 18 months', 'description': '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.'}, {'measure': 'The Elongation Index (EI)', 'timeFrame': 'up to 18 months', 'description': '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.'}, {'measure': '4- Meters Gait Speed Test - 4MGST', 'timeFrame': 'up to 18 months', 'description': "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."}, {'measure': 'Health Related Quality of Life - HRQoL withe the use of 15D questionnaire.', 'timeFrame': 'up to 18 months', 'description': "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)\n\nMaximum 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."}, {'measure': 'Chest mobility', 'timeFrame': 'up to 18 months', 'description': '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.'}, {'measure': 'Back scratch test', 'timeFrame': 'up to 18 months', 'description': '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.'}, {'measure': 'Interleukin IL 1b', 'timeFrame': 'up to 18 months', 'description': '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.'}, {'measure': 'Interleukin IL-6', 'timeFrame': 'up to 18 months', 'description': '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.'}, {'measure': 'TNF-alfa', 'timeFrame': 'up to 18 months', 'description': '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.'}, {'measure': 'WBC [10⁹/l]', 'timeFrame': 'up to 18 months', 'description': 'White Blood Cell Count - WBC \\[10⁹/l\\]\n\nRepresents 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.'}, {'measure': 'RBC [10¹²/l],', 'timeFrame': 'up to 18 months', 'description': 'Red Blood Cell Count - RBC \\[10¹²/l\\]\n\nIndicates 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.'}, {'measure': 'HGB [g/dl]', 'timeFrame': 'up to 18 months', 'description': 'Hemoglobin Concentration - HGB \\[g/dl\\]\n\nMeasures 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.'}, {'measure': 'HCT [%]', 'timeFrame': 'up to 18 months', 'description': 'Hematocrit - HCT \\[%\\]\n\nRefers 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.'}, {'measure': 'MCV [fl]', 'timeFrame': 'up to 18 months', 'description': 'Mean Corpuscular Volume - MCV \\[fl\\]\n\nReflects the average volume of individual erythrocytes. It helps to classify anemia as microcytic, normocytic, or macrocytic.'}, {'measure': 'MCH [pg]', 'timeFrame': 'up to 18 months', 'description': 'Mean Corpuscular Hemoglobin -MCH \\[pg\\]\n\nIndicates the average amount of hemoglobin per red blood cell. It provides additional insight into the hemoglobin content in different types of anemia.'}, {'measure': 'MCHC [g/dl]', 'timeFrame': 'up to 18 months', 'description': 'Mean Corpuscular Hemoglobin Concentration - MCHC \\[g/dl\\]\n\nRepresents the average concentration of hemoglobin in erythrocytes. Decreased levels suggest hypochromia, commonly observed in iron deficiency anemia.'}, {'measure': 'PLT [109/l]', 'timeFrame': 'up to 18 months', 'description': 'Platelet Count - PLT \\[10⁹/l\\]\n\nDetermines 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.'}, {'measure': 'Reticulocytes {% or ‰]', 'timeFrame': 'up to 18 months', 'description': 'Reticulocytes \\[% or ‰\\]\n\nImmature red blood cells that reflect bone marrow erythropoietic activity. Increased reticulocyte counts indicate active regeneration, commonly seen in response to anemia or blood loss.'}, {'measure': 'CRP [mg/l]', 'timeFrame': 'up to 18 months', 'description': 'C-Reactive Protein - CRP \\[mg/l\\]\n\nAn 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.'}, {'measure': 'Fibrinogen [g/l]', 'timeFrame': 'up to 18 months', 'description': 'Fibrinogen\n\nA 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.'}, {'measure': 'ESR [mm/h]', 'timeFrame': 'up to 18 months', 'description': 'Erythrocyte Sedimentation Rate - ESR \\[mm/h\\]\n\nA 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.'}], 'secondaryOutcomes': [{'measure': 'FEV₁', 'timeFrame': '2 weeks', 'description': 'Forced Expiratory Volume in One Second \\[L\\] - FEV₁\n\nFEV₁ represents the volume of air forcibly exhaled during the first second of a forced expiratory maneuver, starting from full lung inflation.\n\nIt 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.\n\nLower FEV₁ values indicate narrowing of the airways or reduced lung function.'}, {'measure': 'FVC', 'timeFrame': '2 weeks', 'description': 'Forced Vital Capacity \\[L\\] - FVC\n\nFVC is the total volume of air that can be forcibly exhaled after a full inspiration.\n\nIt 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.'}, {'measure': 'PEF', 'timeFrame': '2 weeks', 'description': 'Peak Expiratory Flow \\[L/min\\] - PEF\n\nPEF represents the maximum flow rate achieved during a forced expiratory maneuver.\n\nIt 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.\n\nReduced PEF may indicate airway narrowing, poor effort, or respiratory muscle weakness.'}, {'measure': 'Bronchodilator Reversibility (BDR) Test', 'timeFrame': '2 weeks', 'description': '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).\n\nThe 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.'}, {'measure': 'Resting tongue posture', 'timeFrame': '2 weeks', 'description': '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.'}, {'measure': '3-Day Food Diary', 'timeFrame': 'up to 18 months', 'description': '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:\n\nProvide a snapshot of typical eating behaviors and meal patterns.\n\nIdentify potential nutritional deficiencies or imbalances.\n\nAssess the relationship between diet and health outcomes in clinical studies'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary function, speleotherapy, blood tests, 6MWT, chest'], 'conditions': ['the Elderly', 'Respiratory Disorders']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nVolunteers 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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,\n* patients who gave informed, written consent to participate in the study.\n\nExclusion Criteria:\n\n* patients with contraindications to subterraneotherapy and physical exercise,\n* lack of written consent to participate in the study,\n* deterioration of health during the implementation of the program."}, 'identificationModule': {'nctId': 'NCT06951633', 'acronym': 'PRSC-FERPBR', 'briefTitle': 'Effects of Pulmonary Rehabilitation in Salt Chambers on Functional Efficiency, Respiratory Parameters, and Blood Rheology in Elderly With Respiratory Diseases.', 'organization': {'class': 'OTHER', 'fullName': 'University School of Physical Education, Krakow, Poland'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '29/RID/2025'}, 'secondaryIdInfos': [{'id': 'No. 022/ RID/SP/0027/2024/01', 'type': 'OTHER_GRANT', 'domain': 'Minister of Science and Higher Education'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Subterranean, pulmonary rehabilitation', 'description': "Pulmonary rehabilitation in the underground salt chambers of the 'Wieliczka' Salt Mine Health Resort", 'interventionNames': ['Other: Subterranean, pulmonary rehabilitation']}], 'interventions': [{'name': 'Subterranean, pulmonary rehabilitation', 'type': 'OTHER', 'description': "Pulmonary rehabilitation in the underground Health Resort of the 'Wieliczka' Salt Mine", 'armGroupLabels': ['Subterranean, pulmonary rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32-020', 'city': 'Wieliczka', 'state': 'Wieliczka', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Magdalena Kostrzon, PhD', 'role': 'CONTACT', 'email': 'magdalena.kostrzon@kopalnia.pl', 'phone': '+48602713143'}, {'name': 'Marek Koprowski, PhD', 'role': 'CONTACT', 'email': 'marek.koprowski@kopalnia.pl', 'phone': '+48604884364'}, {'name': 'Sylwia Mętel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Health Resort 'Wieliczka' Salt Mine in Wieliczka", 'geoPoint': {'lat': 49.98738, 'lon': 20.06473}}], 'centralContacts': [{'name': 'Sylwia Mętel, PhD', 'role': 'CONTACT', 'email': 'sylwia.metel@awf.krakow.pl', 'phone': '+48606480472'}, {'name': 'Magdalena Kostrzon, PhD', 'role': 'CONTACT', 'email': 'magdalena.kostrzon@kopalnia.pl', 'phone': '+48602713143'}], 'overallOfficials': [{'name': 'Sylwia Mętel, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Physicsl Culture in Krakow, Poland al. Jana Pawła II 78, 31-571 Kraków'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University School of Physical Education, Krakow, Poland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}