Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT03327935
Status:
COMPLETED
Last Update Posted:
2020-07-23
First Post:
2017-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-discharge Nutrition and Resistance Training in Surgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009752', 'term': 'Nutritional Status'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Baseline data are collected prior to the randomization and thus are masked. But during and after the intervention both participants and investigators are unblinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3 groups of 50 patients each by randomization'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2017-10-27', 'studyFirstSubmitQcDate': '2017-10-31', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Loss of lean body mass', 'timeFrame': '8 weeks', 'description': 'Non-bone lean mass measured by dual energy x-ray absorptiometry (DXA) whole-body scans'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malnutrition', 'Surgery']}, 'descriptionModule': {'briefSummary': 'Randomized intervention by nutritional supplements and training in postoperative patients after discharge', 'detailedDescription': 'Surgery combined with malnutrition is associated with loss of muscle mass and leads to serious consequences for the surgical patient. A majority of surgical patients continue to lose weight after discharge. Nutritional risk screening has not been fully implemented at Landssjúkrahúsið - the National Hospital of the Faroe Islands and therefore the prevalence of patients at nutritional risk is unknown. The aim of this study is to examine whether an intervention with independent nutritional supplements or an intervention combining nutritional supplements and resistance training is more effective in preventing loss of muscle mass than standard care in surgical patients following discharge. Secondary outcomes are changes in body weight, quality of life, muscle strength and activities of daily living. Furthermore, we want to screen hospitalized surgical patients for nutritional risk in order to get an estimate of the prevalence of nutritional risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to the surgical departments at Landssjúkrahúsið - National Hospital of Faroe Islands\n* Aged 18 years or above\n* One or more of the following surgical procedures: knee alloplasty, hip alloplasty, collum femoris fracture, back fracture, abdominal surgery, mamma surgery and other comprehensive surgery\n* At nutritional risk according to screening\n\nExclusion Criteria:\n\n* Minimally invasive surgery/Laparoscopic surgery\n* Severely reduced kidney function (p-creatinin\\>250 mikromol/l) or dialysis\n* Terminal illness\n* Inability to cooperate in tests or exercises due to cognitive function or dementia\n* Admitted to intensive care unit\n* Inability to speak or understand Faroese, Danish or English\n* Consent according to national regulations not obtainable'}, 'identificationModule': {'nctId': 'NCT03327935', 'acronym': 'MaSu', 'briefTitle': 'Post-discharge Nutrition and Resistance Training in Surgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Malnutrition in Surgical Patients in the Faroe Islands: Post-discharge Nutrition and Resistance Training', 'orgStudyIdInfo': {'id': 'H-17000004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutrition', 'description': 'Oral nutritional supplements and dietetic advice', 'interventionNames': ['Dietary Supplement: Nutrition']}, {'type': 'EXPERIMENTAL', 'label': 'Nutrition and exercise', 'description': 'Oral nutritional supplements, dietetic advice and exercise training', 'interventionNames': ['Dietary Supplement: Nutrition']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard Hospital Procedure'}], 'interventions': [{'name': 'Nutrition', 'type': 'DIETARY_SUPPLEMENT', 'description': '150 Faroese surgical patients randomized to one of the following three arms 1) oral nutritional supplements and advice, 2) oral nutritional supplements and training exercise and 3) Standard hospital procedure. Primary outcome is loss of lean body mass', 'armGroupLabels': ['Nutrition', 'Nutrition and exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Tórshavn', 'country': 'Faroe Islands', 'facility': 'National Hospital of Faroe Islands', 'geoPoint': {'lat': 62.00973, 'lon': -6.77164}}], 'overallOfficials': [{'name': 'Jens Rikardt R Andersen', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Health Insurance Fund of Research Council Faroe Islands', 'class': 'UNKNOWN'}, {'name': 'National Hospital of the Faroe Islands', 'class': 'OTHER_GOV'}, {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jens Rikardt Andersen', 'investigatorAffiliation': 'University of Copenhagen'}}}}