Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT04508218
Status:
COMPLETED
Last Update Posted:
2020-08-11
First Post:
2020-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Protein Supplementation and Exercise Training in Burn Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-07', 'studyFirstSubmitDate': '2020-08-05', 'studyFirstSubmitQcDate': '2020-08-07', 'lastUpdatePostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lean body mass', 'timeFrame': 'after 12 week of intervention', 'description': 'The QDR 4500A densitometry system DXA (Hologic Inc., Bedford, USA) was used according to the manufacturer instructions for calculating LBM'}], 'secondaryOutcomes': [{'measure': 'muscle strength', 'timeFrame': 'after 12 week of intervention', 'description': 'The Biodex 3 Dynamometer Medical System (Shirley, USA) was utilized for strength assessment of quadriceps muscle of the dominant leg (concentric test) of the participants. It was performed according to manufacturer instructions.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise training', 'Protein supplementation', 'Muscle strength', 'Lean body mass', 'Burn'], 'conditions': ['Burns']}, 'descriptionModule': {'briefSummary': 'Burn injury causes continuous catabolism of the skeletal muscle resulting in decreased muscle strength, muscle mass and impairment of functional mobility. Purpose: The purpose of this study is to investigate the efficacy of combination of exercise training and protein supplementation on lean body mass (LBM) and muscle strength in patients with severe burn.', 'detailedDescription': 'Sixty participants with severe burn \\> 30% total body surface area (TBSA) were randomly distributed into 4 equal groups of 15 participants per group. Group A (Protein+ Exercise group) received oral protein supplementation, exercise program and traditional burn care, group B (Protein group) received oral protein supplementation and traditional burn care, group C (Exercise group) received exercise program and traditional burn care, group D (Control group) received traditional burn care. LBM was measured using Dual-energy x-ray absorptiometry (DXA) while muscle strength was measured using Biodex 3 Dynamometer System before treatment and 12 weeks after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healed deep partial-thickness thermal burn\n* \\> 30% of TBSA and\n* the exercise program started after healing of the burn (after burn injury by 6 weeks)\n\nExclusion Criteria:\n\n* conditions that may affect on participation in the exercise program as a recent coronary disease, uncontrolled hypertension, orthopedic problems limiting exercise, abnormal cardiac stress test, pregnant women, refusal to participate in a physical activity program,\n* presence of psychological or cognitive disorders (aggressive behavior, impulsivity, dementia)\n* food intolerance to milk protein products.'}, 'identificationModule': {'nctId': 'NCT04508218', 'briefTitle': 'Protein Supplementation and Exercise Training in Burn Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Impact of Adding Protein Supplementation to Exercise Training on Lean Body Mass and Muscle Strength in Burn Patients', 'orgStudyIdInfo': {'id': 'P.T.REC/012/002758'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Protein+ Exercise group', 'description': 'Received oral protein supplementation, exercise program and traditional burn care', 'interventionNames': ['Dietary Supplement: whey protein supplementation powder (Inkospor X-TREME; France)', 'Other: Exercise training program', 'Other: traditional burn care']}, {'type': 'EXPERIMENTAL', 'label': 'Protein group', 'description': 'Received oral protein supplementation and traditional burn care', 'interventionNames': ['Dietary Supplement: whey protein supplementation powder (Inkospor X-TREME; France)', 'Other: traditional burn care']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise group', 'description': 'Received exercise program and traditional burn care', 'interventionNames': ['Other: Exercise training program', 'Other: traditional burn care']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Received traditional burn care', 'interventionNames': ['Other: traditional burn care']}], 'interventions': [{'name': 'whey protein supplementation powder (Inkospor X-TREME; France)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Protein requirements for burned adults are estimated as 1.5-2.0 g/kg/day. The participants asked to take the calculated serving of whey protein dissolved in 150ml of water two times / day in the morning and in the evening', 'armGroupLabels': ['Protein group', 'Protein+ Exercise group']}, {'name': 'Exercise training program', 'type': 'OTHER', 'description': 'After healing of the burn (6 weeks after injury), participants in group A and group C started resisted exercise program with a qualified therapist for 1 hour three times/week on nonconsecutive days over 12 weeks. In addition, aerobic exercises were conducted on the treadmill. Peak oxygen consumption was assessed for all patients by using the exercise test on treadmill before participation in aerobic exercises.', 'armGroupLabels': ['Exercise group', 'Protein+ Exercise group']}, {'name': 'traditional burn care', 'type': 'OTHER', 'description': 'ROM exercises, stretching, ADL activities and scar management', 'armGroupLabels': ['Control group', 'Exercise group', 'Protein group', 'Protein+ Exercise group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'facility': 'Nesma Morgan Allam', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Nesma M Allam, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'lecturer at faculty of physical therapy'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '6 months after puplication', 'ipdSharing': 'YES', 'description': 'results of the study', 'accessCriteria': 'study protocol'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Nesma Morgan Allam', 'investigatorAffiliation': 'Cairo University'}}}}