[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652561":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":42,"locations":50,"responsibleParty":80,"collaborators":83,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":18,"enrollmentInfo":99,"targetDuration":18,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":69,"whyStopped":18,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"University of Milan","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Personalized pre-habilitation exercise training program and lifestyle counseling","EXPERIMENTAL","Participants receive specific recommendations for maintaining an active lifestyle, with additional guidance on nutritional habits, stress management, substance use, alcohol consumption, smoking, and sleep.\n\nFurthermore, participants are asked to wear a wrist-worn wearable device for the entire duration of the intervention in order to monitor their adherence to the intervention program: a 16-week personalized pre-habilitation exercise training, that includes a combination of aerobic endurance exercises, aimed at enhancing exercise capacity, and muscle-strengthening exercises, aimed at increasing muscle mass and strength.",[13],"Behavioral: Pre-habilitation exercise program",{"label":15,"type":16,"description":17,"interventionNames":18},"Lifestyle counseling","NO_INTERVENTION","Participants receive specific recommendations for maintaining an active lifestyle, with additional guidance on nutritional habits, stress management, substance use, alcohol consumption, smoking, and sleep.\n\nFurthermore, participants are asked to wear a wrist-worn wearable device for the entire duration of the intervention in order to track physical activity habits.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Pre-habilitation exercise program","Participants undertake a 16-week personalized pre-habilitation exercise training program as follows:\n\n* Aerobic training: five times per week with an initial session duration set at 45 minutes.The initial target intensity is set at 40% of the Heart Rate Reserve (HRR). Both duration and intensity are progressively increased based on individual exercise tolerance, aiming for an intensity of approximately 60% HRR and a duration of 60 minutes per session.\n* Resistance training: twice per week, ensuring at least 24-48 hours of recovery between sessions. Patients follow the prescribed number of sets and repetitions demonstrated in in the video tutorials provided by the study staff.",[9],[26,29,32,34,37,40],{"name":27,"affiliation":5,"role":28},"Francesca Bianchi, PhD","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":31,"role":28},"Christine Desmedt, PhD","Laboratory for Translational Breast Cancer Research, Ku Leuven",{"name":33,"affiliation":5,"role":28},"Valentina Bollati, PhD",{"name":35,"affiliation":5,"role":36},"Elia M Biganzoli, PhD","STUDY_DIRECTOR",{"name":38,"affiliation":39,"role":28},"Elena Barbieri, PhD","Università degli Studi di Urbino Carlo Bo'",{"name":41,"affiliation":5,"role":28},"Roberta Biciuffi, MSc",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":18,"email":47},"Elia M Biganzoli, Professor","CONTACT","+39 02503 19652","elia.biganzoli@unimi.it",{"name":41,"role":45,"phone":18,"phoneExt":18,"email":49},"roberta.biciuffi@unimi.it",[51,67],{"facility":52,"status":53,"city":54,"state":18,"zip":18,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico","NOT_YET_RECRUITING","Milan","Italy","IT",{"type":58,"coordinates":59},"Point",[60,61],9.18951,45.46427,{"lat":61,"lon":60},[64],{"name":65,"role":45,"phone":18,"phoneExt":18,"email":66},"Ornella Garrone","ornella.garrone@policlinico.mi.it",{"facility":68,"status":69,"city":70,"state":18,"zip":18,"country":55,"countryCode":56,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"University of Urbino \"Carlo Bo\"","RECRUITING","Urbino",{"type":58,"coordinates":72},[73,74],12.63633,43.72621,{"lat":74,"lon":73},[77],{"name":78,"role":45,"phone":18,"phoneExt":18,"email":79},"Elena Barbieri","elena.barbieri@uniurb.it",{"type":28,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Elia Mario Biganzoli","Full Professor of Medical Statistics",[84,85,87],{"name":68,"class":6},{"name":86,"class":6},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico",{"name":88,"class":6},"Istituto Auxologico Italiano","100652561","physical-activity-and-healthy-aging-promoting-cardio-metabolic-capacity-to-fight-chronic-inflammation-and-improve-outcomes-in-breast-cancer-patients-phacthealth-study-100652561",false,"NCT07776951","Physical Activity and Healthy Aging: Promoting Cardio-metabolic Capacity to Fight Chronic Inflammation and Improve Outcomes in Breast Cancer Patients (PhActHealth Study)","PhActHealth - Physical Activity and Healthy Aging: Fighting Low Grade Chronic Inflammation to Put Out the Cardio-oncologic Risk","PhActHealth","Inclusion Criteria:\n\n* being a patient with first diagnosis of primary BC;\n* luminal BC tumor subtype B defined as positive for estrogen and\u002For progesterone receptor expression, HER2 negative and high Ki-67; or triple Negative BC tumor subtype defined as negative for estrogen and\u002For progesterone receptor expression, HER2 negative, defined by the Pathology and Medical Oncology units as defined by the ESMO Guidelines Committee (referred to the American Society of Clinical Oncology\u002FCollege of American Pathologists guidelines for assessment of hormone receptor (HR) status (i.e. ER and 4 PgR)25 and HER2 status, and by the International Ki-67 in Breast Cancer Working Group for Ki-67);\n* candidate for chemotherapy\u002Fimmunotherapy neoadjuvant treatment;\n* signed informed consent for study participation;\n* declared being not engaged in any competitive or recreational physical activity.\n\nExclusion Criteria:\n\n* therapeutic modifications during the intervention period;\n* presence of chronic conditions (such as autoimmune diseases, neurodegenerative diseases, psychiatric disorders\u002Fcognitive disabilities, chronic obstructive pulmonary disease);\n* presence of any condition that significantly impairs the ability to perform exercise;\n* pregnancy\u002Flactation\u002Fintention to initiate pregnancy;\n* prior chemotherapy or immunotherapy within the past three years;\n* high baseline physical activity level (i.e. performing exercise at a dose of 600 MET minutes a week or greater, according to the score of the International Physical Activity Questionnaire \\[IPAQ\\]).","FEMALE","18 Years",{"count":100,"type":101},126,"ESTIMATED","INTERVENTIONAL",[104],"NA","PhActHealth is a multicenter randomized controlled trial enrolling women with newly diagnosed luminal B or triple-negative breast cancer (BC) who are candidates for neoadjuvant therapy. The study aims to investigate the effects of a preoperative, unsupervised exercise training program on exercise capacity, as well as on immune response, autonomic nervous system (ANS) regulation, cardiovascular health, and tumor aggressiveness prior to surgical removal.\n\nParticipants are randomly assigned to either an intervention group or a control group. All patients receive lifestyle counseling, while those in the intervention group additionally follow a personalized aerobic and resistance exercise program throughout the neoadjuvant treatment period before surgery.\n\nThe primary outcome is the improvement in exercise capacity. The secondary outcomes are tumor-specific and systemic responses to the intervention, evaluated by analyzing molecular, metabolic, and inflammatory markers, as well as clinical and functional parameters.",[107],"Breast Cancer",[109,110,111,112,113,114],"chronic inflammation","luminal B breast cancer","Triple Negative Breast Cancer (TNBC)","lifestyle intervention","exercise","METs","2026-08-17",{"date":117,"type":118},"2026-08-20","ACTUAL",{"date":120,"type":118},"2026-02-01",{"date":122,"type":101},"2029-02-28",{"name":5,"class":6},2]