protocolSection identificationModule nctId: NCT06302634, orgStudyIdInfo id: ReCO, secondaryIdInfos id: 2022/137, type: OTHER, domain: Comité de Ética de la Investigación de Santiago-Lugo, briefTitle: Cardio-Oncology Rehabilitation Care Process, acronym: ReCO, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-22, primaryCompletionDateStruct date: 2027-06-22, completionDateStruct date: 2027-06-22, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Hospital Clinico Universitario de Santiago, class: OTHER, descriptionModule briefSummary: The objective of this observational study is to assess the outcomes of a hospital-based Cardio-Oncology Rehabilitation (CORe) program focused on exercise in cancer patients undergoing cardiotoxic treatment. This evaluation will be conducted by analyzing disease-related health indicators, functional capacity, and quality of life. Patients at risk of cardiotoxicity attending the Cardio-Onco-Hematology Unit will be offered the exercise program, which includes two modalities: in-person (center-based) and remote (home-based) options. The assignment to either modality is non randomized, based on the functional assessment conducted in the Rehabilitation Unit and the agreement between healthcare professional and patient. All participants will perform a 3-month supervised exercise intervention. There are 3 time points for assessment: at baseline (T0), 3-month after the exercise program (T1) and follow-up at 9 months from baseline (T2)., conditionsModule conditions: Cardio-Oncology, conditions: Rehabilitation, conditions: Cardiovascular Diseases, conditions: Exercise, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Exercise-based cardio-oncology rehabilitation, outcomesModule primaryOutcomes measure: Change in left ventricular systolic function quantified by left ventricular ejection fraction and global longitudinal strain by transthoracic echocardiography, primaryOutcomes measure: Increased cardiac biomarkers (Troponin I and BNP/NT-proBNP), primaryOutcomes measure: Decrease in functional capacity assessed by estimated VO2peak, primaryOutcomes measure: Change in cardiovascular risk profile as assessed by the presence or absence of classic cardiovascular risk factors., primaryOutcomes measure: Changes in fasting blood glucose, primaryOutcomes measure: Changes in total low-density lipoprotein (LDL) and total cholesterol (TC) levels, primaryOutcomes measure: Change in haemoglobin, primaryOutcomes measure: Significant cardiovascular and non-cardiovascular adverse effects during treatment., secondaryOutcomes measure: Change in health-related quality of life assessed by the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire., secondaryOutcomes measure: Change in localized lower limb functional capacity assessed by number of repetitions performed within 30 seconds in the sit-to-stand test., secondaryOutcomes measure: Change in lower limb strength measured by squat dynamometry (kg)., secondaryOutcomes measure: Change in biceps strength by dynamometry (kg)., secondaryOutcomes measure: Change in perimeter (cm) of the right thigh 5cm above the upper edge of the patella, secondaryOutcomes measure: Changes in peak expiratory flow, secondaryOutcomes measure: Change in upper limb strength measured by dynamometry (kg)., secondaryOutcomes measure: Change in anthropometric parameters: weight in kg., secondaryOutcomes measure: Change in anthropometric parameters: Body mass index (BMI) in kg/m^2, secondaryOutcomes measure: Change in anthropometric parameters: abdominal circumference in cm., secondaryOutcomes measure: Change in resting heart rate measured by pulse oximetry (beats per min)., secondaryOutcomes measure: Change in resting blood pressure (mmHg) measured by a blood pressure monitor., secondaryOutcomes measure: Change in physical activity assessed by the score in the Godin Leisure Test Exercise Questionnaire (GLTEQ)., secondaryOutcomes measure: Change in cardiovascular treatment by its presence or absence., otherOutcomes measure: Adherence and compliance to cardiac rehabilitation program (CBCORe) assessed by number of training sessions attended/number of sessions planned., otherOutcomes measure: Compliance to home-based cardiac rehabilitation program (HBCORe) assessed by the total number of telephone calls during the Physiotherapy follow-up and the total time of telephone calls., otherOutcomes measure: Security of the cardiac rehabilitation program assessed by number of adverse events during training (CBCORe)., otherOutcomes measure: Satisfaction with the CORe program, otherOutcomes measure: Follow-up of the exercise performed after participation in the CORe program, otherOutcomes measure: Presence or absence of lymphoedema., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Clínico Universitario de Santiago, status: RECRUITING, city: Santiago de Compostela, state: A Coruña, zip: 15706, country: Spain, contacts name: Carlos Peña-Gil, MD, PhD, role: CONTACT, phone: +34 981 950 778, email: carlos.pena.gil@sergas.es, contacts name: Estíbaliz Díaz-Balboa, role: CONTACT, phone: +34 981950747, email: estibaliz.diaz.balboa@sergas.es, geoPoint lat: 42.88052, lon: -8.54569, hasResults: False