[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602364":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":37,"centralContacts":37,"locations":54,"responsibleParty":75,"collaborators":37,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":37,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":37,"enrollmentInfo":86,"targetDuration":37,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":57,"whyStopped":37,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University School of Physical Education, Krakow, Poland","OTHER",[8,18,23,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Pulmonary Rehabilitation in Salt Chambers","EXPERIMENTAL","Participants undergo a 16-day pulmonary rehabilitation program conducted in therapeutic salt chambers. The intervention includes general fitness, respiratory and relaxation exercises, health education. Conducted under supervision of a multidisciplinary team (physiotherapist, nurse, dietitian, physician). Sessions take place in the underground salt chambers of the \"Wessel\" complex (Salt Mine 'Wieliczka', Wieliczka, Poland).",[13,14,15,16,17],"Behavioral: Therapeutic stay in subterranean sanatorium chambers (microclimate therapy)","Behavioral: Breathing exercises","Behavioral: General fitness exercises","Behavioral: Relaxation training","Behavioral: Health education",{"label":19,"type":20,"description":21,"interventionNames":22},"Surface Rehabilitation","ACTIVE_COMPARATOR","Participants undergo the same 16-day pulmonary rehabilitation program as in Arm 1, but conducted in standard surface conditions without exposure to salt chamber microclimate.",[14,15,16,17],{"label":24,"type":10,"description":25,"interventionNames":26},"Passive Stay in Salt Chambers","Participants attend daily 180-minutes passive sessions in therapeutic salt chambers for 16 days, without any physical exercise component.",[13,17],{"label":28,"type":20,"description":29,"interventionNames":30},"Health education only","Participants receive printed materials and general health education related to COPD management. No supervised exercise or microclimatic exposure is included.",[17],[32,38,42,46,50],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"BEHAVIORAL","Therapeutic stay in subterranean sanatorium chambers (microclimate therapy)","Characteristics of the underground environment in the Wieliczka sanatorium chambers:\n\nStable climatic conditions: relative humidity ranging from 60-75%, temperature between 12.9-14.5°C; High chemical and biological air purity; Mineral content in the air: 2.7-8.1 mg\u002Fm³, consisting mainly of chloride, sodium, potassium, calcium, and fluoride ions; Air ionization: 1,200-4,700 aeroions\u002Fcm³ of air. Elevated atmospheric pressure: increased by approximately 16-20 mmHg compared to surface conditions.",[24,9],null,{"type":33,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"Breathing exercises","30 minutes daily. Breathing exercises will include active respiratory exercises, drainage and effective coughing techniques, resistance training of the respiratory muscles, chest mobilization and relaxation exercises, breathing through pursed lips, as well as short and prolonged exhalation exercises.",[9,19],{"type":33,"name":43,"description":44,"armGroupLabels":45,"otherNames":37},"General fitness exercises","30 minutes daily. General conditioning exercises will incorporate components aimed at improving overall aerobic capacity (e.g., walking-based activities, dance routines, step exercises), flexibility and coordination (e.g., stretching and balance exercises), and strength (e.g., exercises using resistance bands or dumbbells). The training will be conducted in interval, circuit, and free-form formats. Resistance levels will be individually adjusted to the patient's capacity.",[9,19],{"type":33,"name":47,"description":48,"armGroupLabels":49,"otherNames":37},"Relaxation training","30 minutes, once during the entire cycle. Relaxation training will include rest in a seated position, with dimmed lighting and calming music.",[9,19],{"type":33,"name":51,"description":52,"armGroupLabels":53,"otherNames":37},"Health education","Educational materials in printed form for distribution covering the following topics:\n\nCOPD - information about the disease;\n\nBreathing exercises and bronchial hygiene;\n\nBenefits of physical activity, including examples of exercises that can be performed at home.",[28,24,9,19],[55],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"AKF Kraków","RECRUITING","Krakow","Małopolska","30-009","Poland","PL",{"type":64,"coordinates":65},"Point",[66,67],19.93658,50.06143,{"lat":67,"lon":66},[70],{"name":71,"role":72,"phone":73,"phoneExt":37,"email":74},"Paweł Janus, master","CONTACT","*48 502189055","pawel.janus@doctoral.awf.krakow.pl",{"type":76,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100602364","pulmonary-rehabilitation-in-salt-chambers-for-patients-with-copd-100602364",false,"NCT07122544","Pulmonary Rehabilitation in Salt Chambers for Patients With COPD","The Impact of Pulmonary Rehabilitation Conducted in Therapeutic Salt Chambers on the Clinical Status of Patients With Chronic Obstructive Pulmonary Disease (COPD)","Inclusion Criteria:\n\n* COPD diagnosis confirmed by a pulmonology specialist according to the 2025 GOLD guidelines.\n* FEV1 ≥ 30% of the predicted value.\n* FEV1\u002FFVC \\\u003C 0.7 after bronchodilator administration in spirometry.\n* Negative bronchodilator reversibility test.\n* Voluntary written consent to participate in the study.\n\nExclusion Criteria:\n\n* COPD exacerbation.\n* Active cancer or a history of cancer within the past five years.\n* Musculoskeletal disorders preventing independent movement and participation in exercise tests and training included in the study protocol.\n* Recent (within six months) surgical procedure or trauma to the chest, abdomen, skull, brain, or eye area.\n* Severe valvular heart disease.\n* Implanted cardioverter-defibrillator.\n* Diagnosed arrhythmias posing a risk of loss of consciousness.\n* Acute coronary artery disease.\n* Epilepsy.\n* Uncontrolled arterial hypertension despite medication.\n* Primary or secondary immunodeficiencies.\n* Respiratory failure requiring chronic or intermittent oxygen therapy.\n* Infectious diseases with fever during the experiment or within two weeks before the study.\n* Claustrophobia.\n* Pregnancy.\n* Simultaneous participation in another rehabilitation program.\n* Significant changes in pharmacological treatment during the study.","ALL","18 Years",{"count":87,"type":88},80,"ESTIMATED","INTERVENTIONAL",[91],"NA","Title: The Impact of Pulmonary Rehabilitation Conducted in Therapeutic Salt Chambers on the Clinical Condition of Patients with Chronic Obstructive Pulmonary Disease\n\nBackground and Rationale:\n\nChronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory disorder that significantly reduces patients' quality of life and functional capacity. In the search for supportive therapeutic strategies, there is growing interest in unconventional therapeutic environments such as therapeutic salt chambers. The underground climate of the \"Wieliczka\" Salt Mine in Poland - characterized by humidity 60-75%, temperature 12.9-14.5°C, high air purity and ionization - has shown therapeutic potential. However, the clinical effects of pulmonary rehabilitation conducted in such an environment in COPD patients remain insufficiently documented.\n\nStudy Objective:\n\nTo evaluate the effect of pulmonary rehabilitation and climatic therapy conducted in underground salt chambers on the clinical condition of patients with stable COPD.\n\nResearch Question:\n\nDoes pulmonary rehabilitation conducted in a subterranean salt mine environment offer measurable clinical benefits compared to standard surface-based rehabilitation?\n\nStudy Design and Methods:\n\nThis is a randomized, controlled, four-arm interventional study including 80 adult patients with a confirmed diagnosis of COPD according to the GOLD 2025 criteria. Participants will be randomly assigned to one of four groups:\n\nGroup A: Pulmonary rehabilitation in underground therapeutic salt chambers (physical training + microclimate exposure).\n\nGroup B: Pulmonary rehabilitation in a surface-level gymnasium (physical training without microclimate exposure).\n\nGroup C: Passive stay in underground salt chambers (microclimate exposure without physical training).\n\nGroup D: Health education only (control group, surface level).\n\nThe intervention program consists of 16 consecutive working days of 3-hour daily sessions. The content of the rehabilitation varies depending on the assigned group and includes general conditioning exercises, respiratory exercises, relaxation training, and health education.\n\nOutcome Measures and Assessment Tools:\n\nClinical assessments will be conducted at three time points: prior to the intervention (T0), immediately after the intervention (T1), and at a 3-month follow-up (T2 - for Groups A and B only). The monitored variables include:\n\nExercise Tolerance: Incremental Shuttle Walk Test (ISWT)\n\nHealth-Related Quality of Life: St. George's Respiratory Questionnaire\n\nCOPD Symptoms and Risk Indexes: COPD Assessment Test (CAT), BODE Index\n\nMuscle Strength: Deadlift test, hand dynamometer, 30-second Chair Stand Test\n\nRespiratory Muscle Strength: Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP)\n\nBody Composition: Bioelectrical Impedance Analysis (BIA)\n\nDyspnea Scales: Borg Scale, modified Medical Research Council (mMRC) scale\n\nChest Mobility: Measuring tape assessment\n\nThe study is designed to evaluate both the immediate and long-term effects of different pulmonary rehabilitation models on clinical outcomes in COPD patients, with a focus on whether the underground environment enhances rehabilitation efficacy.",[94],"COPD (Chronic Obstructive Pulmonary Disease)",[96],"speleotherapy","2025-11-25",{"date":99,"type":100},"2025-11-26","ACTUAL",{"date":102,"type":100},"2025-09-01",{"date":104,"type":88},"2028-01-01",{"name":5,"class":6},1]