[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100494638":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":49,"responsibleParty":160,"collaborators":68,"id":162,"slug":163,"hasResults":164,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":68,"eligibilityCriteria":168,"healthyVolunteers":164,"sex":169,"minAge":170,"maxAge":171,"enrollmentInfo":172,"targetDuration":68,"studyType":175,"phases":176,"briefSummary":178,"conditions":179,"keywords":181,"overallStatus":72,"whyStopped":68,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},{"fullName":5,"class":6},"Istituti Clinici Scientifici Maugeri SpA","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual training with the support of music (MS)","EXPERIMENTAL","This is the group performing training with the support of the music; it will be the intervention study group (MS)",[13],"Other: MS group",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual training without music (C)","ACTIVE_COMPARATOR","This is the usual training group without the support of the music, it will be the control group (C)",[19],"Other: C group",[21,27],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"MS group","All patients will perform the usual training by listening a piece of music of the same duration as the training. The patient will be able to choose among 4 different musical proposals corresponding to 4 different styles: rock, modern, jazz and classical. The song chosen by the patient will be the musical support for all the sessions of training on the cycle ergometer. The musical pieces will be composed with a constant rhythm (bpm=60) which, from a tonal point of view, will echo the pedaling movement. The constant rhythm will be superimposed on musical patterns in the form of loops in the styles mentioned. The musical support will assume a \"priming\" (activation) and \"dragging\" (synchronization) function, facilitating movement planning\u002Fsynchronization and creating a pleasant context in which to carry out training",[9],[26],"Experimental",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"C group","All patients will perform 12 to 14 supervised sessions depending on the center they belong to (5-6 sessions\u002Fweek) each consisting of 30 minutes of exercise at the cycle ergometer plus 3 minutes of warm-up and 3 minutes of recovery. After a warm-up phase at 0 W, the initial workload will be set to 60% of the theoretical maximum. Intensity increases or decreases of 10 W will be made according to the criteria of Maltais et al (workload will be increased when patients will report dyspnea and\u002For leg fatigue as ≤3 on a Borg scale modified to 10 points of perceived effort. The training load will remain unchanged if the Borg score is 4 or 5 and will be reduced for scores ≥6). Patients will have to maintain a pedaling frequency between 55 and 60 rpm.",[15],[32],"Active Comparatore",[34],{"name":35,"affiliation":36,"role":37},"Michele Vitacca, MD","ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Lumezzane","STUDY_DIRECTOR",[39,44],{"name":35,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","0039+030+8253","182","michele.vitacca@icsmaugeri.it",{"name":45,"role":40,"phone":46,"phoneExt":47,"email":48},"Tiziana Bachetti, Pharm","+0039+0382+593","210","tiziana.bachetti@icsmaugeri.it",[50,70,88,109,128,142],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Telese","NOT_YET_RECRUITING","Telese Terme","Benevento","82037","Italy","IT",{"type":59,"coordinates":60},"Point",[61,62],14.52681,41.21752,{"lat":62,"lon":61},[65],{"name":66,"role":40,"phone":67,"phoneExt":68,"email":69},"Mauro Maniscalco, MD","+0039+0824+909350",null,"mauro.maniscalco@icsmaugeri.it",{"facility":71,"status":72,"city":73,"state":74,"zip":75,"country":56,"countryCode":57,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane","RECRUITING","Lumezzane","Brescia","25065",{"type":59,"coordinates":77},[78,79],10.26487,45.64789,{"lat":79,"lon":78},[82,84],{"name":35,"role":40,"phone":83,"phoneExt":42,"email":43},"+0039+030+8253",{"name":85,"role":40,"phone":83,"phoneExt":86,"email":87},"Mara Paneroni, PhD, MSc, PT","122","mara.paneroni@icsmaugeri.it",{"facility":89,"status":72,"city":90,"state":91,"zip":92,"country":56,"countryCode":57,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Montescano","Montescano","Pavia","27040",{"type":59,"coordinates":94},[95,96],9.28366,45.03196,{"lat":96,"lon":95},[99,104],{"name":100,"role":40,"phone":101,"phoneExt":102,"email":103},"Rodolfo Murgia, MD","+0039+0385+247","324","rodolfo.murgia@icsmaugeri.it",{"name":105,"role":40,"phone":106,"phoneExt":107,"email":108},"Giancarlo Piaggi, MSc, PT","+0039+0385 +247","402","giancarlo.piaggi@icsmaugeri.it",{"facility":110,"status":72,"city":111,"state":112,"zip":113,"country":56,"countryCode":57,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Tradate","Tradate","Varese","21049",{"type":59,"coordinates":115},[116,117],8.90763,45.70843,{"lat":117,"lon":116},[120,124],{"name":121,"role":40,"phone":122,"phoneExt":68,"email":123},"Antonio Spanevello, MD, Prof","+0039+0331+829500","antonio.spanevello@icsmaugeri.it",{"name":125,"role":40,"phone":126,"phoneExt":68,"email":127},"Elisabetta Zampogna, MSc, PT","+0039+0331+829596","elisabetta.zampogna@icsmaugeri.it",{"facility":129,"status":52,"city":130,"state":68,"zip":131,"country":56,"countryCode":57,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Bari","Bari","70100",{"type":59,"coordinates":133},[134,135],16.86982,41.12066,{"lat":135,"lon":134},[138],{"name":139,"role":40,"phone":140,"phoneExt":68,"email":141},"Maria Aliani, MD","+0039+080+7814374","maria.aliani@icsmaugeri.it",{"facility":143,"status":72,"city":91,"state":68,"zip":144,"country":56,"countryCode":57,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Pavia","27100",{"type":59,"coordinates":146},[147,148],9.15917,45.19205,{"lat":148,"lon":147},[151,156],{"name":152,"role":40,"phone":153,"phoneExt":154,"email":155},"Piero Ceriana, MD","+0039+0382+592","804","piero.ceriana@icsmaugeri.it",{"name":157,"role":40,"phone":46,"phoneExt":158,"email":159},"Alfredo Raglio","796","alfredo.raglio@icsmaugeri.it",{"type":161,"investigatorFullName":68,"investigatorTitle":68,"investigatorAffiliation":68,"oldNameTitle":68,"oldOrganization":68},"SPONSOR","100494638","rehabilitation-training-with-music-support--exercise-tolerance-in-copd-and-crf-patients-100494638",false,"NCT05720780","Rehabilitation Training With Music-support & Exercise Tolerance in COPD and CRF Patients.","Can Rehabilitation Training With Music-support Increase Exercise Tolerance in Individuals With COPD and CRF Compared to Rehabilitation Training Alone? A Randomized Control Trial.","Inclusion Criteria:\n\n* Diagnosis of COPD (Forced expiratory volume in 1 second \u002F post-bronchodilator forced vital capacity \\\u003C 0.7) without functional reversibility\n* Chronic respiratory failure with stable hypoxia (PaO2 \\\u003C 60 mmHg in room air)\n* Long Term Oxygen Therapy (LTOT) for at least 3 months\n* Clinical stability: pH range 7.38-7.42, with no recent exacerbations in the last 7 days and no changes in drug therapy in the previous 7 days\n\nExclusion Criteria:\n\n* Non-invasive ventilation at home\n* Cognitive impairment (Mini-Mental State Examination Score \\\u003C 22)\n* Asthma or evidence of bronchodilator response\n* Pulmonary fibrosis\n* Obstructive sleep apnea syndrome\n* Lung cancer\n* Active microbial infections\n* Neuromuscular, orthopedic, and\u002For medical conditions that preclude testing\n* Pulmonary rehabilitation program in the previous 6 months","ALL","40 Years","85 Years",{"count":173,"type":174},156,"ESTIMATED","INTERVENTIONAL",[177],"NA","Therapeutic-rehabilitative interventions supported by music can be considered important resources in many clinical contexts. Some studies report the improvement of psychological (i.e. anxiety) and physiological parameters such for example, dyspnea, blood pressure, quality of life, sleep disturbances, etc. through voice, singing, exercise with wind instruments, and sometimes listening to music. Among the various instruments proposed to support the physical training of COPD patients, music was also tested and, in particular, music as a distracting auditory stimulus (DAS) has been used to increase exercise and physical activity adherence and to reduce the perception of dyspnea in COPD subjects.\n\nThis randomized controlled trial will compare -in patients with COPD and CRF- the effects of the addiction of music to the training on exercise capacity (possible improvement of endurance and reduction of fatigue and dyspnea) with respect to the usual rehabilitation modality (no music).",[180],"COPD",[182,180,183,184,185],"distracting auditory stimulus (DAS)","CRF","music therapy","rehabilitation","2026-02-20",{"date":188,"type":189},"2026-02-23","ACTUAL",{"date":191,"type":189},"2023-01-26",{"date":193,"type":174},"2027-04-30",{"name":5,"class":6},6]