Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 4:41 PM
Study NCT ID:
NCT04205760
Status:
UNKNOWN
Last Update Posted:
2022-05-26
First Post:
2019-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Nutritional Optimization and Physical Exercise for Patients Scheduled for Elective Implantation for a Left-Ventricular Assist Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009752', 'term': 'Nutritional Status'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'functional outcome assessor will be blinded to study group allocation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'National multicenter two-group randomized-controlled, blinded to assessor clinical pilot trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-12-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-25', 'studyFirstSubmitDate': '2019-12-18', 'studyFirstSubmitQcDate': '2019-12-18', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of adverse events', 'timeFrame': 'up to 2 weeks before surgery', 'description': 'adverse events between groups related to cycling and nutritional complications'}, {'measure': 'Separation of caloric supplementation', 'timeFrame': 'up to 2 weeks before surgery', 'description': 'Separation between groups on prescribed caloric targets'}, {'measure': 'Separation of protein supplementation', 'timeFrame': 'up to 2 weeks before surgery', 'description': 'Separation between groups on prescribed protein targets'}, {'measure': 'Proportion of interventions received as prescribed', 'timeFrame': 'up to 2 weeks before surgery', 'description': 'Proportion of interventions received as prescribed'}, {'measure': 'Rate of patients recruited per month', 'timeFrame': 'up to 18 months', 'description': 'Target: 1.5 patients per month'}, {'measure': 'Ratio of control patients received physiotherapy', 'timeFrame': 'up to 2 weeks before surgery', 'description': 'Ratio of control patients received physiotherapy'}, {'measure': 'Ratio of control patients received nutritional support', 'timeFrame': 'up to 2 weeks before surgery', 'description': 'Ratio of control patients received nutritional support'}], 'secondaryOutcomes': [{'measure': 'mortality rates at day 30', 'timeFrame': 'day 30 after randomization', 'description': 'mortality rates at day 30'}, {'measure': 'rates of ICU length of stay', 'timeFrame': 'up to 3 months', 'description': 'rates of ICU length of stay'}, {'measure': 'rates of hospital length of stay', 'timeFrame': 'up to 3 months', 'description': 'rates of hospital length of stay'}, {'measure': 'Mean duration of mechanical ventilation', 'timeFrame': 'up to 3 months', 'description': 'Mean duration of mechanical ventilation'}, {'measure': 'Incidence of complications', 'timeFrame': 'up to 3 months', 'description': 'Incidence of complications'}, {'measure': 'Incidence of infections', 'timeFrame': 'up to 3 months', 'description': 'Incidence of infections'}, {'measure': 'Change in Mid-arm circumference', 'timeFrame': 'up to 6 months', 'description': 'baseline values versus follow-up values'}, {'measure': 'Change in Muscle mass - Quadriceps thickness', 'timeFrame': 'up to 6 months', 'description': 'ultrasound, baseline values versus follow-up values'}, {'measure': 'Change in Muscle mass - Quadriceps cross sectional area', 'timeFrame': 'up to 6 months', 'description': 'ultrasound, baseline values versus follow-up values'}, {'measure': 'Change in Muscle strength - Handgrip strength', 'timeFrame': 'up to 6 months', 'description': 'Dynamometry, baseline values versus follow-up values'}, {'measure': 'Change in Muscle strength - Quadriceps strength', 'timeFrame': 'up to 6 months', 'description': 'Dynamometry, baseline values versus follow-up values'}, {'measure': 'Change of Clinical Frailty score (CFS)', 'timeFrame': 'up to 6 months', 'description': 'baseline values versus follow-up values; Score: 1-9 (very fit: 1, terminally ill: 9)'}, {'measure': 'Change in Physical function - 6-Minute Walk Test', 'timeFrame': 'up to 6 months', 'description': 'baseline values versus follow-up values, 6-minute walking distance'}, {'measure': 'Change in Physical function - Short Physical Performance Battery', 'timeFrame': 'up to 6 months', 'description': 'baseline values versus follow-up values,(Score: 0-12; 0=worst performance and 12=best performance)'}, {'measure': 'Change in Physical function - Functional Status Score for the ICU', 'timeFrame': 'up to 6 months', 'description': 'baseline values versus follow-up values,(Score 0-35; the higher the score, the better physical functioning)'}, {'measure': 'Change in quality of life - Lawton Instrumental Activities of Daily Living (IADL)', 'timeFrame': 'up to 6 months', 'description': 'baseline values versus follow-up values, (score 0-8; the higher the more independent)'}, {'measure': 'Change in quality of life - Katz Activities of Daily Living (ADL)', 'timeFrame': 'up to 6 months', 'description': 'baseline values versus follow-up values,(Score: 0-100; the higher the more independent)'}, {'measure': 'Quality of life - Short Form 36 (SF-36)', 'timeFrame': 'up to 6 months', 'description': 'baseline values versus follow-up values,(Score: 0-100; 100=no limitation in daily life and 0=completely limited)'}, {'measure': 'Change in neurological function - Mini Mental State Examination', 'timeFrame': 'up to 6 months', 'description': 'baseline values versus follow-up values, (score: 0-30; the higher the less cognitively impaired)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LVAD', 'preoperative optimization', 'end-stage heart failure', 'cardiac surgery', 'nutrition therapy', 'exercise', 'cycling'], 'conditions': ['Left Ventricular Assist Device', 'End-stage Heart Failure', 'Cardiac Surgery']}, 'descriptionModule': {'briefSummary': "This is a pilot, randomized, multicenter interventional trial of a combined preoperative oral nutritional support (ONS) and physical exercise therapy in patients planned for elective implantation of a left-ventricular assist device (LVAD). This pilot study pursues to demonstrate the feasibility and safety of a study protocol to optimize the patients' nutritional and physical state to reduce the number of postoperative complications and consequently to ameliorate the patients' outcome.", 'detailedDescription': "The oral nutrition supplementation will be started immediately after randomization and will be continued until surgery. The patients will receive a dosage of ONS adjusted to their nutritional risk. Regular monitoring of blood sugars, electrolytes, phosphate, and triglycerides will occur twice per week, as per standard protocol.\n\nIn-bed cycling will be started as soon as possible after randomization. Cycling sessions will be performed daily for 50 minutes, at least 5 times a week until surgery. Standard safety criteria will be assessed prior to initiating cycling treatments. The in-bed cycling will be performed passively or actively with graded increasing resistance. All cycling interventions will be performed under 1:1 supervision of medically trained study personnel while monitoring patient's heart rate, systolic and diastolic blood pressure and transcutaneous oxygen saturation of blood.\n\nWhen evaluating the effect of a combined nutritional and exercise intervention, other important co-interventions should be standardized to reduce potential confounding of trial outcomes. All study patients should be fed with an oral diet that is in accordance to local standards, whereas it is strongly recommended to adhere to current clinical practice guidelines. Besides, the investigators highly encourage daily respiratory therapy in both groups plus mobilization as much as feasible.\n\nAll other key interventions during preoperative treatment will be standardized in accordance to the local clinical practice. Study teams will follow up on the patients on a daily base, documenting adherence with study interventions and key co-interventions.\n\nPatients in the control group will not receive preoperative ONS. No bed cycling will be allowed from admission until surgery. Neither of these practices are the current standard of care in the participating unit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Given informed consent\n2. Adult patients (≥18 years)\n3. Patients undergoing elective LVAD implantation Additional cardiac surgery, such as bypass grafting, or valve repair is permitted\n\nExclusion Criteria:\n\n1. Hospital admission \\<5 days prior to planned LVAD implantation\n2. Patients on ECMO or INTERMACS\\<1\n3. Patients already receiving nutrition support on hospital admission\n4. Enteral nutrition is contraindicated.\n5. Pregnant or lactating patients\n6. Patients with clinical fulminant hepatic failure\n7. Patients with cirrhosis Child's Class C Liver Disease\n8. Patients with clinical kidney failure or requiring hemodialysis\n9. Known allergy or intolerance to study nutrients\n10. Intracranial or spinal process affecting motor function\n11. Lower extremity impairments that prevent cycling\n12. Disabling neuropsychiatric disorders or language barriers\n13. Weight \\> 150 kg\n14. Enrolment in an industry sponsored randomized trial within the last 30 days (co-enrolment in academic randomized trials will be considered on a case by case basis)"}, 'identificationModule': {'nctId': 'NCT04205760', 'acronym': 'PROPER-LVAD', 'briefTitle': 'Preoperative Nutritional Optimization and Physical Exercise for Patients Scheduled for Elective Implantation for a Left-Ventricular Assist Device', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Preoperative Nutritional Optimization and Physical Exercise for Patients Scheduled for Elective Implantation for a Left-Ventricular Assist Device', 'orgStudyIdInfo': {'id': '19-136'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Standard Care as per local guidelines'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Oral nutrition support (ONS) and bed-cycling before surgery', 'interventionNames': ['Combination Product: Nutrition + exercise']}], 'interventions': [{'name': 'Nutrition + exercise', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['bed cycling', 'ONS'], 'description': 'Patients will receive preoperative optimization consisting of oral nutrition support (Fresubin 3.2 kcal) and bed-cycling (50 minutes per day) for 5-14 days before surgery.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bad Oeynhausen', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Vera von Dossow', 'role': 'CONTACT'}], 'facility': 'Heart Center Bad Oeynhausen', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'city': 'Aachen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Aileen Hill, Dr. med.', 'role': 'CONTACT'}, {'name': 'Elena Laaf, MSc', 'role': 'CONTACT'}], 'facility': 'RWTH Aachen University', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'city': 'Dresden', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Klaus Matschke, Univ.-Prof. Dr. med. habil.', 'role': 'CONTACT'}], 'facility': 'Heart Center Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Giessen', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Bernd Niemann, PD Dr. med.', 'role': 'CONTACT'}], 'facility': 'University Hospital Justus-Liebig University Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'city': 'Kiel', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Bernd Panholzer, Dr. med.', 'role': 'CONTACT'}], 'facility': 'University Medical Center Schleswig-Holstein, Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}], 'centralContacts': [{'name': 'Aileen Hill, Dr. med.', 'role': 'CONTACT', 'email': 'ahill@ukaachen.de', 'phone': '+49 241 80', 'phoneExt': '38166'}, {'name': 'Elena Laaf, MSc', 'role': 'CONTACT', 'email': 'elaaf@ukaachen.de', 'phone': '+49 241 80', 'phoneExt': '89021'}], 'overallOfficials': [{'name': 'Christian Stoppe, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RWTH Aachen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Christian Stoppe', 'investigatorAffiliation': 'RWTH Aachen University'}}}}