[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627695":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":143,"collaborators":25,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":25,"eligibilityCriteria":151,"healthyVolunteers":147,"sex":152,"minAge":153,"maxAge":25,"enrollmentInfo":154,"targetDuration":25,"studyType":157,"phases":158,"briefSummary":160,"conditions":161,"keywords":166,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},{"fullName":5,"class":6},"Istituti Clinici Scientifici Maugeri SpA","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"6-Minute Walk Test With Usual Oxygen or Room Air (O2REST)","ACTIVE_COMPARATOR","All participants perform the 6-minute walk test with standard oxygen flow (or room air for participants with exertional hypoxemia only). This arm represents the standard condition for comparison.\n\nThe test may be administered as first or second test, in a random order, according to the crossover design.",[13],"Other: Usual Oxygen During 6-Minute Walk Test",{"label":15,"type":16,"description":17,"interventionNames":18},"6-Minute Walk Test With Supplemental Oxygen (O2PLUS)","EXPERIMENTAL","All participants perform the 6-minute walk test using a higher oxygen flow during exercise to evaluate the effects of supplemental oxygen on walking performance and symptoms.\n\nThe test may be administered as first or second test, in a random order, according to the crossover design.",[19],"Other: Supplemental Oxygen During 6-Minute Walk Test",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Usual Oxygen During 6-Minute Walk Test","Participants perform the 6-minute walk test using the oxygen flow prescribed at rest for chronic respiratory failure, or room air for participants with exertional hypoxemia only. Oxygen is delivered through nasal cannula using standard equipment. Walking distance, oxygen saturation, heart rate, and symptoms are recorded during the test.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Supplemental Oxygen During 6-Minute Walk Test","Participants perform the 6-minute walk test using supplemental oxygen during exercise. Oxygen flow is set at double the resting prescription for participants with chronic respiratory failure, or at two liters per minute for participants with exertional hypoxemia. Oxygen is delivered through nasal cannula using standard equipment. Walking distance, oxygen saturation, heart rate, and symptoms are recorded during the test.",[15],[31],{"name":32,"affiliation":33,"role":34},"Mara Paneroni, PhD, MSc","ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","+39 030 8253","167","mara.paneroni@icsmaugeri.it",[42,61,79,96,112,127],{"facility":33,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Lumezzane","Brescia","25065","Italy","IT",{"type":50,"coordinates":51},"Point",[52,53],10.26487,45.64789,{"lat":53,"lon":52},[56,58],{"name":57,"role":37,"phone":25,"phoneExt":25,"email":40},"Mara Paneroni",{"name":59,"role":37,"phone":25,"phoneExt":25,"email":60},"Michele Vitacca","michele.vitacca@icsmaugeri.it",{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":47,"countryCode":48,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Veruno","NOT_YET_RECRUITING","Veruno","Novara","28013",{"type":50,"coordinates":68},[69,70],8.52863,45.68887,{"lat":70,"lon":69},[73,76],{"name":74,"role":37,"phone":25,"phoneExt":25,"email":75},"Manuela Bianchi","manuela.bianchi@icsmaugeri.it",{"name":77,"role":37,"phone":25,"phoneExt":25,"email":78},"Armando Capelli","armando.capelli@icsmaugeri.it",{"facility":80,"status":43,"city":81,"state":82,"zip":83,"country":47,"countryCode":48,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Montescano","Montescano","Pavia","27040",{"type":50,"coordinates":85},[86,87],9.28366,45.03196,{"lat":87,"lon":86},[90,93],{"name":91,"role":37,"phone":25,"phoneExt":25,"email":92},"Giancarlo Piaggi","giancarlo.piaggi@icsmaugeri.it",{"name":94,"role":37,"phone":25,"phoneExt":25,"email":95},"Rodolfo Murgia","rodolfo.murgia@icsmaugeri.it",{"facility":97,"status":43,"city":98,"state":25,"zip":99,"country":47,"countryCode":48,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Bari","Bari","70124",{"type":50,"coordinates":101},[102,103],16.86982,41.12066,{"lat":103,"lon":102},[106,109],{"name":107,"role":37,"phone":25,"phoneExt":25,"email":108},"Maddalena Genco","maddalena.genco@icsmaugeri.it",{"name":110,"role":37,"phone":25,"phoneExt":25,"email":111},"Mauro Carone","mauro.carone@icsmaugeri.it",{"facility":113,"status":43,"city":82,"state":25,"zip":114,"country":47,"countryCode":48,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Pavia","27100",{"type":50,"coordinates":116},[117,118],9.15917,45.19205,{"lat":118,"lon":117},[121,124],{"name":122,"role":37,"phone":25,"phoneExt":25,"email":123},"Serena Cirio","serena.cirio@icsmaugeri.it",{"name":125,"role":37,"phone":25,"phoneExt":25,"email":126},"Piero Ceriana","piero.ceriana@icsmaugeri.it",{"facility":128,"status":63,"city":129,"state":25,"zip":130,"country":47,"countryCode":48,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Istituti Clinici Maugeri , Respiratory rehabilitation of the Institute of Marina di Ginosa","Taranto","74025",{"type":50,"coordinates":132},[133,134],17.24707,40.46438,{"lat":134,"lon":133},[137,140],{"name":138,"role":37,"phone":25,"phoneExt":25,"email":139},"Francesco Lorusso","francesco.lorusso@icsmaugeri.it",{"name":141,"role":37,"phone":25,"phoneExt":25,"email":142},"Aldo Diasparra","aldo.diasparra@icsmaugeri.it",{"type":144,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100627695","effects-of-oxygen-supplementation-during-the-6-minute-walk-test-in-chronic-respiratory-failure-or-exertional-hypoxemia-100627695",false,"NCT07451977","Effects of Oxygen Supplementation During the 6-Minute Walk Test in Chronic Respiratory Failure or Exertional Hypoxemia","Evaluation of the Effects of the Oxygen Supplementation During 6-minute Walking Test in Patients With Chronic Respiratory Failure or Exertional Hypoxiemia","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Diagnosis of chronic respiratory disease admitted for pulmonary rehabilitation\n* One of the following conditions at discharge:\n* Chronic obstructive pulmonary disease with exertional hypoxemia\n* Chronic obstructive pulmonary disease with chronic respiratory failure requiring long-term oxygen therapy\n* Interstitial lung disease with chronic respiratory failure requiring long-term oxygen therapy\n* Clinically stable condition for at least one month\n* Optimized medical therapy during hospitalization\n* Ability to perform the 6-minute walk test\n* Signed informed consent\n\nExclusion Criteria:\n\n* Lung diseases other than chronic obstructive pulmonary disease or interstitial lung disease\n* Resting oxygen flow requirement greater than 4 liters per minute\n* Orthopedic, neurological, or cognitive conditions that may limit walking performance\n* Recent cardiovascular or cerebrovascular events within the previous 3 months","ALL","18 Years",{"count":155,"type":156},114,"ESTIMATED","INTERVENTIONAL",[159],"NA","The aim of this multicenter crossover trial is to describe the effect of adding a therapeutic dose of exertional oxygen therapy, in terms of exercise performance, gas exchange, heart rate, symptoms perception and subjective easiness of performance, in a cohort of subjects hospitalized in specialized pulmonary rehabilitation centers with a diagnosis of chronic respiratory failure and\u002For exertional hypoxemia due to chronic obstructive pulmonary disease or interstitial lung disease.\n\nResearchers will compare the walking performance during 6-minute walk test performed with the liters of oxygen administered as prescribed at rest (for patients with chronic respiratory failure) or in room air (for patients with exertional hypoxemia only), to the performance during a 6-minute walk test performed with the double the flow rate prescribed at rest, or with 2 L\u002Fmin for patients with exertional hypoxemia only. The two tests will be performed in random order, at least 3 hours apart and no later than 24 hours apart from each other.\n\nThe main outcome will be the difference between the distance walked in the two 6-minute walk test in the two conditions. Furthermore, will be also collected and compared: the oxygen saturation and heart rate every minute, the initial and final dyspnea and fatigue, as assessed by Borg scale, and the easiness of performance through a dedicated questionnaire. The estimated sample size will be 114 patients.\n\nThis study will provide some basis for a more accurate prescription of exercise-related oxygen therapy, offering insights into the phenotype of patients who may derive the greatest benefit from this intervention. It will also stimulate discussion regarding the optimal timing and dosing of oxygen administration during exertion in patients with respiratory failure.",[162,163,164,165],"Chronic Respiratory Failure","Hypoxemia","Chronic Obstructive Pulmonary Disease (COPD)","Interstitial Lung Disease",[167,168,169,170,171,172],"oxygen supplementation","6-minute walk test","chronic respiratory failure","exertional hypoxemia","pulmonary rehabilitation","exercise tolerance","2026-06-19",{"date":175,"type":176},"2026-06-23","ACTUAL",{"date":178,"type":176},"2026-04-02",{"date":180,"type":156},"2028-09-30",{"name":5,"class":6},6]