[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577771":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":48,"centralContacts":53,"locations":63,"responsibleParty":101,"collaborators":105,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":110,"sex":116,"minAge":117,"maxAge":35,"enrollmentInfo":118,"targetDuration":35,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":128,"overallStatus":135,"whyStopped":35,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Universidade do Porto","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group (CG)","ACTIVE_COMPARATOR","Control group will receive a single in-person preoperative education session at the Faculty of Sport of University of Porto, one week after the patient's inclusion in the study. The education session will be delivered for the patient and his\u002Fher caregiver or family member.\n\nThe information that will be delivery is going to be focused on:\n\n* Lifestyle changes regarding nutrition and daily physical activity.\n* Abstinence of the additive behaviors smoking, alcohol, and drug consumption.\n* Personal hygiene care and hospital routines.\n* Importance of postoperative physiotherapy. A booklet summarizing the information provided at the education session will be delivered for all participants.",[13],"Other: Education session",{"label":15,"type":16,"description":17,"interventionNames":18},"Inspiratory Muscle Training Group (IMT-G)","EXPERIMENTAL","The IMT-G will be submitted to an education session (equal to the CG) plus 2-weeks of inspiratory muscle training (IMT).\n\nAfter the education session, patients will start the IMT program that will last two weeks. The IMT will be 5 days\u002F week, lasting \\~20 minutes, using the PowerBreath KH2 device. All sessions will start with 5 min of stretching exercises and then the IMT. In the first week, the intensity of the PowerBreath KH2 will be set at 50% of the maximal inspiratory pressure (with 12 breaths per minute), and it will be increasing by 10% in the second week (with 15 breaths per minute). Patients will be continuously monitored by an oximeter and modified Borg scale All IMT session will take place at São João Hospital.",[13,19],"Other: Inspiratory muscle training group",{"label":21,"type":16,"description":22,"interventionNames":23},"Expiratory Muscle Training Group (EMT-G)","The EMT-G will be submitted to an education session (equal to the CG) plus 2-weeks of expiratory muscle training (EMT).\n\nAfter the education session, patients will start the EMT that will last two weeks, 5 days a week.\n\nThe sessions will last \\~20 minutes and will be structured as follows:\n\n* 5 minutes of stretching exercises\n* 8 minutes of abdominal resistance exercises (1st week: 2 exercises, 4 sets of 8 repetitions; 2nd week: 2 exercises, 4 sets of 10 repetitions)\n* 8 minutes of specific EMT using the Philips Respironics Threshold PEP device (Load: 20 cmH2O; 10 expirations for minute) Patients will be continuously monitored by an oximeter and modified Borg scale. All EMT session will take place at São João Hospital.",[13,24],"Other: Expiratory muscle training group",{"label":26,"type":16,"description":27,"interventionNames":28},"Global Exercise Training Group (GET-G)","The GET-G will be submitted to an education session (equal to the CG) plus 2-weeks of physical exercise, 3 sessions per week, 45-60 minutes.\n\nThe structure is:\n\nWarm-up 5 minutes of whole-body stretching exercises\n\nMain workout:\n\n-Aerobic: Week 1: 20 min of treadmill walking at 70% of the mean speed achieved on the 6-minute walk test and limited by 80% of the max theoretical heart rate. Week 2: 20 min of treadmill walking at 80% of the mean speed achieved on the 6-minute walk test and limited by 80% of the max theoretical heart rate.\n\n-Resistance Week 1: 8 exercises, 2 sets of 8-10 repetitions, using body weight and elastic bands. Week 2: 8 exercises, 2 sets of 10-12 repetitions, using body weight and elastic bands Coll-down: 5 min of whole-body stretching exercises, holding the point of feeling lightness discomfort for 15 seconds.\n\nPatients will be continuously monitored by an oximeter and modified Borg scale.",[13,29],"Other: Global exercise training group",[31,36,40,44],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Education session","The information that will be delivery is going to be focused on:\n\n* Lifestyle changes regarding nutrition and daily physical activity.\n* Abstinence of the additive behaviors smoking, alcohol, and drug consumption.\n* Personal hygiene care and hospital routines.\n* Importance of postoperative physiotherapy. A booklet summarizing the information provided at the education session will be delivered for all participants.",[9,21,26,15],null,{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Inspiratory muscle training group","Education Session (described in the control group) Inspiratory muscle training (IMT) After the education session, patients will start the IMT program that will last two weeks.\n\nThe IMT will be 5 days\u002F week, lasting 20 minutes, using the PowerBreath KH2 device. In the first week, the intensity of the PowerBreath KH2 will be set at 50% of the maximal inspiratory pressure (with 12 breaths per minute), and it will be increasing by 10% in the second week (with 15 breaths per minute). Patients will be continuously monitored by an oximeter and modified Borg scale",[15],{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"Expiratory muscle training group","Education Session (described in the control group) Expiratory muscle training (EMT)\n\nAfter the education session, patients will start the EMT that will last two weeks, 5 days a week. The sessions will last 20 minutes and will be structured as follows:\n\n4 minutes of total body stretching exercises 8 minutes of abdominal resistance exercises:\n\n1. First week: 2 exercises, 4 sets of 8 repetitions\n2. Second week: 2 exercises, 4 sets of 10 repetitions 8 minutes of specific EMT using the Philips Respironics Threshold PEP device (Load: 20 cmH2O; 10 expirations for minute) Patients will be continuously monitored by an oximeter and modified Borg scale.",[21],{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":35},"Global exercise training group","The GET-G will be submitted to an education session (equal to the CG) plus 2-weeks of physical exercise, 3 sessions per week, 45-60 minutes.\n\nThe structure is:\n\nWarm-up: 5 minutes of whole-body stretching exercises\n\nMain workout:\n\n-Aerobic: Week 1: 20 min of treadmill walking at 70% of the mean speed achieved on the 6-minute walk test and limited by 80% of the max theoretical heart rate. Week 2: 20 min of treadmill walking at 80% of the mean speed achieved on the 6-minute walk test and limited by 80% of the max theoretical heart rate.\n\n-Resistance Week 1: 8 exercises, 2 sets of 8-10 repetitions, using body weight and elastic bands. Week 2: 8 exercises, 2 sets of 10-12 repetitions, using body weight and elastic bands Coll-down: 5 min of whole-body stretching exercises, holding the point of feeling lightness discomfort for 15 seconds.\n\nPatients will be continuously monitored by an oximeter and modified Borg scale.",[26],[49],{"name":50,"affiliation":51,"role":52},"José F Oliveira, PhD","Faculty of Sport - University of Porto","STUDY_CHAIR",[54,59],{"name":55,"role":56,"phone":57,"phoneExt":35,"email":58},"Filipa C Kendall, PhD","CONTACT","00351919840750","fckendall@fade.up.pt",{"name":60,"role":56,"phone":61,"phoneExt":35,"email":62},"Lucimére Bonh, PhD","00351917028600","licimerebohn@fade.up.pt",[64],{"facility":51,"status":35,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Porto","Porto District","4200-450","Portugal","PT",{"type":71,"coordinates":72},"Point",[73,74],-8.61097,41.1485,{"lat":74,"lon":73},[77,80,83,84,86,88,90,92,94,96,98,100],{"name":78,"role":56,"phone":79,"phoneExt":35,"email":58},"Filipa Kendall, Phd","+351919840750",{"name":60,"role":56,"phone":81,"phoneExt":35,"email":82},"+351917028600","lucimerebonh@fade.up.pt",{"name":50,"role":56,"phone":35,"phoneExt":35,"email":35},{"name":85,"role":56,"phone":35,"phoneExt":35,"email":35},"Débora G Silva, Masters",{"name":87,"role":56,"phone":35,"phoneExt":35,"email":35},"Luísa Gonçalves, PhD",{"name":89,"role":56,"phone":35,"phoneExt":35,"email":35},"Pedro Fernandes, MD",{"name":91,"role":56,"phone":35,"phoneExt":35,"email":35},"Ana Godinho, FT",{"name":93,"role":56,"phone":35,"phoneExt":35,"email":35},"Cristina Teixeira, Masters",{"name":95,"role":56,"phone":35,"phoneExt":35,"email":35},"Gabriela Fernandes, PhD",{"name":97,"role":56,"phone":35,"phoneExt":35,"email":35},"Ermelinda Eusébio",{"name":99,"role":56,"phone":35,"phoneExt":35,"email":35},"Lucimére Bohn, Phd",{"name":78,"role":56,"phone":35,"phoneExt":35,"email":35},{"type":102,"investigatorFullName":103,"investigatorTitle":104,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"PRINCIPAL_INVESTIGATOR","Filipa Kendall","Investigator",[106],{"name":107,"class":6},"Centro Hospitalar De São João, E.P.E.","100577771","prehabilitation-for-lung-cancer-patients-undergoing-lung-resection-100577771",false,"NCT06802627","Prehabilitation for Lung Cancer Patients Undergoing Lung Resection","Influence of Prehabilitation on Postoperative Pulmonary Complications in Patient Undergoing Lung Resection Surgery","Fit4LungNeo","Inclusion Criteria:\n\n* Adult patients accepted for lung resection surgery, due to lung cancer, at the Cardiothoracic Department of Unidade Local de Saúde São João\n* Not included in any type of prehabilitation program\n\nExclusion Criteria:\n\n* Diagnosis of cardiac, or hematological or neurologic diseases\n* Pulmonary hypertension\n* Renal failure\n* Patients that underwent previous thoracic surgery\n* Patients submitted to pneumectomy\n* Patients with cognitive and mental disorders\n* Patients with impairments in autonomous deambulation\n* Patients already included in any prehabilitation program","ALL","18 Years",{"count":119,"type":120},200,"ESTIMATED","INTERVENTIONAL",[123],"NA","Lung surgical resection is the gold standard treatment for earlier stages of lung cancer patients. Nevertheless, postoperative pulmonary complications (PPC) are frequent, related to morbidity and mortality, increasing length of hospital stay (LOS), hospital costs, delaying adjuvant treatments, and patients suffering. The PPC often occurs on postoperative days, even after hospital discharge. Prehabilitation might reduce PPC, although few studies have compared the effectiveness of different training protocols, and no information is available regarding the possible benefits of expiratory muscle training. Moreover, there are no comparisons of the cost-benefits of other protocols in patients submitted to lung resection surgery.\n\nThis project investigates the effectiveness of and compares four different prehabilitation protocols in reducing PPC and LOS in patients selected for lung cancer resections.\n\nParticipants will be individuals referred to surgical resection due to lung cancer. Patients who meet the inclusion criteria will be invited to participate in the study. After clinical data collection, patients will be randomly allocated (simple method) into four groups \\[Control - CG, receiving an education session; Inspiratory muscle training group (IMT-G) receiving education session plus inspiratory muscle training (IMT); expiratory muscle training group (EMT-G) receiving education session plus expiratory muscle training (EMT); global exercise training group (GET-G) receiving education session plus a general exercise training (GET)\\], and evaluated for functional capacity (pulmonary function, respiratory muscle function, physical fitness, daily physical activity, dyspnoea, fatigue, quality of life, anxiety, depression, and a 24-hour food diary. Afterward, all patients will receive an education class and written information regarding healthy habits to follow before, during, and after hospital discharge. Patients allocated to exercise groups will start the prehabilitation intervention for two weeks. After the intervention, patient assessments will be repeated. After that, patients will be submitted to surgery, and anesthetic and surgical procedure data will be collected. During hospital recovery, all patients will receive physiotherapy and any etiological complications and the LOS will be recorded according to medical criteria. After hospital discharge, PPC will be monitored and recorded for 30 days; by then, patients will be submitted to the final assessment.",[126,127],"Lung Cancer","Lung Resection",[129,130,131,132,133,134],"Prehabilitation","Lung resection","Exercise training","Postoperative pulmonary complications","Respiratory muscle training","Education","NOT_YET_RECRUITING","2025-01-24",{"date":138,"type":139},"2025-01-31","ACTUAL",{"date":141,"type":120},"2025-03-01",{"date":143,"type":120},"2027-11-30",{"name":5,"class":6},1]