nctId: NCT06302634 id: ReCO id: 2022/137 type: OTHER domain: Comité de Ética de la Investigación de Santiago-Lugo briefTitle: Cardio-Oncology Rehabilitation Care Process acronym: ReCO overallStatus: RECRUITING date: 2022-06-22 date: 2027-06-22 date: 2027-06-22 date: 2024-03-12 date: 2024-03-15 name: Hospital Clinico Universitario de Santiago class: OTHER 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). conditions: Cardio-Oncology conditions: Rehabilitation conditions: Cardiovascular Diseases conditions: Exercise studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Exercise-based cardio-oncology rehabilitation measure: Change in left ventricular systolic function quantified by left ventricular ejection fraction and global longitudinal strain by transthoracic echocardiography measure: Increased cardiac biomarkers (Troponin I and BNP/NT-proBNP) measure: Decrease in functional capacity assessed by estimated VO2peak measure: Change in cardiovascular risk profile as assessed by the presence or absence of classic cardiovascular risk factors. measure: Changes in fasting blood glucose measure: Changes in total low-density lipoprotein (LDL) and total cholesterol (TC) levels measure: Change in haemoglobin measure: Significant cardiovascular and non-cardiovascular adverse effects during treatment. measure: Change in health-related quality of life assessed by the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4) questionnaire. measure: Change in localized lower limb functional capacity assessed by number of repetitions performed within 30 seconds in the sit-to-stand test. measure: Change in lower limb strength measured by squat dynamometry (kg). measure: Change in biceps strength by dynamometry (kg). measure: Change in perimeter (cm) of the right thigh 5cm above the upper edge of the patella measure: Changes in peak expiratory flow measure: Change in upper limb strength measured by dynamometry (kg). measure: Change in anthropometric parameters: weight in kg. measure: Change in anthropometric parameters: Body mass index (BMI) in kg/m^2 measure: Change in anthropometric parameters: abdominal circumference in cm. measure: Change in resting heart rate measured by pulse oximetry (beats per min). measure: Change in resting blood pressure (mmHg) measured by a blood pressure monitor. measure: Change in physical activity assessed by the score in the Godin Leisure Test Exercise Questionnaire (GLTEQ). measure: Change in cardiovascular treatment by its presence or absence. measure: Adherence and compliance to cardiac rehabilitation program (CBCORe) assessed by number of training sessions attended/number of sessions planned. 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. measure: Security of the cardiac rehabilitation program assessed by number of adverse events during training (CBCORe). measure: Satisfaction with the CORe program measure: Follow-up of the exercise performed after participation in the CORe program measure: Presence or absence of lymphoedema. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clínico Universitario de Santiago status: RECRUITING city: Santiago de Compostela state: A Coruña zip: 15706 country: Spain name: Carlos Peña-Gil, MD, PhD role: CONTACT phone: +34 981 950 778 email: carlos.pena.gil@sergas.es name: Estíbaliz Díaz-Balboa role: CONTACT phone: +34 981950747 email: estibaliz.diaz.balboa@sergas.es lat: 42.88052 lon: -8.54569 hasResults: False