Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
Study NCT ID:
NCT04372550
Status:
UNKNOWN
Last Update Posted:
2020-08-12
First Post:
2020-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Early Exercise Rehabilitation in Severe Burns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Analysis of the primary outcome is carried out blind.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-10', 'studyFirstSubmitDate': '2020-04-30', 'studyFirstSubmitQcDate': '2020-04-30', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Interleukin-1', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Western Blot Chemiluminescence'}, {'measure': 'Change in Interleukin-6', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Western Blot Chemiluminescence'}, {'measure': 'Change in Tumor Necrosis Factor alpha (TNF-α)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Western Blot Chemiluminescence'}, {'measure': 'Change in C-reactive protein', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Western Blot Chemiluminescence'}, {'measure': 'Change in Insulin like growth factor 1 (IGF-1)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Western Blot Chemiluminescence'}, {'measure': 'Change in Glucagon', 'timeFrame': 'Baseline and 12 weeks', 'description': 'ELISA kits DGCG0, R\\&D Systems, Inc, USA'}, {'measure': 'Change in Myostatin', 'timeFrame': 'Baseline and 12 weeks', 'description': 'ELISA kits DGDF80, R\\&D Systems, Inc, USA'}, {'measure': 'Change in isometric peak force (knee extension)', 'timeFrame': 'Baseline and 12 weeks', 'description': "Method: Hand-held dynamometry (Lafayette instrument Co. Europe, U.K.). Isometric peak fore is measured by a 'make' manoeuvre with a fixation band disallowing movement.\n\nTest position: Supine with a fixation band fixed to the hospital bed. Analysis: Best of 3 trials"}, {'measure': 'Change in isometric peak force (hip flexion)', 'timeFrame': 'Baseline and 12 weeks', 'description': "Method: Hand-held dynamometry (Lafayette instrument Co. Europe, U.K.). Isometric peak fore is measured by a 'make' manoeuvre with a fixation band disallowing movement.\n\nTest position: Supine with a fixation band fixed to the hospital bed. Analysis: Best of 3 trials"}, {'measure': 'Change in isometric peak force (hip extension)', 'timeFrame': 'Baseline and 12 weeks', 'description': "Method: Hand-held dynamometry (Lafayette instrument Co. Europe, U.K.). Isometric peak fore is measured by a 'make' manoeuvre with a fixation band disallowing movement.\n\nTest position: Supine with a fixation band fixed to the hospital bed. Analysis: Best of 3 trials"}, {'measure': 'Change in hand grip strength', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Method: Baseline LITE hydraulic dynamometer Analysis: Best of 3 trials'}, {'measure': 'Change in Burn Specific Health Scale-Brief (BSHS-B)', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Burn-specific quality of life, measured by the Burn Specific Health Scale-Brief questionnaire (Mandarin Chinese version).\n\nTotal score 152 (0 worst score, 152 best score), consisting of 6 subdomains:\n\n1\\) Body imagine (36 points) Simple abilities (36 points) Sexuality (24 points) Affect (32 points) Work (16 points) Interpersonal relationship (8 points)'}, {'measure': 'Change in EQ-5D-5L', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Overall quality of life, measured by EQ-5D-5L (Mandarin Chinese version) Total score: 25 points (0 worst score, 25 best score), consisting of 5 subdomains\n\n1. Mobility (5 points)\n2. Self-care (5 points)\n3. Usual activities (5 points)\n4. pain / discomfort (5 points)\n5. Anxiety / Depression (5 points) EQ overall health assessed on a Visual Analogue Scale, Total 0-100 (0 worst, 100 best score)'}, {'measure': 'Number of adverse events', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Recording of complications during exercise: Graft take, Wound infections, Medical, Cardio-respiratory safety'}], 'primaryOutcomes': [{'measure': 'Change in quadriceps muscle layer thickness (QMLT)', 'timeFrame': 'Baseline - 12 weeks', 'description': 'Method: B-mode ultrasound on the anterior aspect of the thigh. Technique: maximal and minimal pressure Location: measured at 1/2 and 2/3 of the distance between anterior superior iliac spine and the superior pole of the patella.\n\nAnalysis: An average of 3 trials will be recorded and analyzed using dedicated software'}, {'measure': 'Change in rectus femoris cross sectional area (RF-CSA)', 'timeFrame': 'Baseline - 12 weeks', 'description': 'Method: B-mode ultrasound on the anterior aspect of the thigh. Technique: minimal pressure. Location: measured at the most proximal distance where the entire muscle belly is still visible on the ultrasound image.\n\nAnalysis: An average of 3 trials will be recorded and analyzed using dedicated software.'}], 'secondaryOutcomes': [{'measure': 'Change in insulin resistance', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Method: HOMA-2 calculated by fasting plasma glucose and insulin, analysed by Western Blot Chemiluminescence'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Burns', 'Exercise rehabilitation', 'Exercise Therapy', 'Muscle wasting', 'Hypermetabolism', 'Insulin resistance'], 'conditions': ['Burns']}, 'descriptionModule': {'briefSummary': "BACKGROUND:\n\nPostburn changes in glucose and protein metabolism are at their peak during the acute phase of severe burns. The resulting metabolic derangements lead to substantial muscle wasting, insulin resistance, which ultimately hampers full recovery and reintegration into society.\n\nPURPOSE:\n\nThis randomized controlled trial was initiated to investigate the effects of exercise-based rehabilitation on muscle wasting, insulin resistance, and quality of life during the acute phase of severe adult burns.\n\nMETHODS:\n\nSeverly burned adults (40-80%TBSA) will be recruited from one of China's largest burn centres.\n\nSubjects allocated to the intervention group will undergo a 6-12 week long exercise program in addition to standard care rehabilitation. As part of the exercise program, participants will carry out progressive resistance and aerobic training, initiated as soon as medical safety and patient cooperation allow. Exercise type and dosage will be chosen according to patient status in terms of grafts, mobility, and strength.\n\nThe control group will receive standard care rehabilitation only, including passive, assisted, active range of motion exercise, functional exercise, and scar treatment.\n\nThe results of this translational research will provide insight into the effects and mechanisms of exercise on both a fundamental and clinical spectrum.", 'detailedDescription': 'The added exercise intervention is initiated in line with the following readiness criteria, which were checked prior to each training session:\n\nCriteria:\n\n* Cardiorespiratory stability:\n* Mean arterial pressure (MAP) 60 - 110 mmHg\n* fraction of inspired oxygen (FiO2) \\<60%\n* partial pressure of oxygen / fraction of inspired oxygen (PaO2/FiO2) \\>200\n* Respiratory rate \\<40 bpm\n* Positive end expiratory pressure (PEEP) \\<10 cmH2O\n* no high inotropic doses (Dopamine \\>10 mcg/kg/min or Nor/adrenaline \\<0,1 mcg/kg/min)\n* Temp. 36 - 38,5°C\n* Richmond Agitation Sedation Scale (RASS) -2 - +2\n* Medical Doctor clearance\n* Medical research council (MRC) score lower limbs ≥3\n\nAccordingly, the post burn starting time differs per enrolled subject.\n\nExercises are administered as in-bed exercises or out-of-bed exercises, depending on whether subjects are able and allowed to engage in out-of-bed mobility.\n\nExercise intensity for resistance training is set at 60% peak force based on a weekly peak force measurement by hand-held dynamometry, or on a 3 RM in case of out of bed exercises. Aerobic exercise intensity is set at 50-75% peak Watts determined by a weekly cycle ergometer or treadmill ramp protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥40 - ≤70 %TBSA\n* Burn depth: 2nd deep / 3rd degree\n\nExclusion Criteria:\n\n* Electrical burn (except flash burns)\n* Associated injury: fracture lower limb\n* Diabetes Mellitus type 1\n* Central neurological/neuromuscular disorders (interfering with assessment/exercise)\n* Cognitive / psychological disorders (interfering with cooperation)\n* Cardiopulmonary disease (interfering with exercise safety)\n* Pregnancy\n* Palliative care'}, 'identificationModule': {'nctId': 'NCT04372550', 'briefTitle': 'Effects of Early Exercise Rehabilitation in Severe Burns', 'organization': {'class': 'OTHER', 'fullName': 'Universiteit Antwerpen'}, 'officialTitle': 'Pathophysiological Mechanisms and Early Exercise Rehabilitation Counter Measures of Hypermetabolism and Muscle Wasting in Severe Burns.', 'orgStudyIdInfo': {'id': '11B8619N'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Standard of care treatment:\n\n\\- including passive / assisted / active movements, stretching, functional exercise, scar treatment\n\nDuration: 6-12 weeks', 'interventionNames': ['Other: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': 'Standard of care + added exercises\n\nExercise type: resistance and aerobic exercise\n\nResistance Exercise: 3x / week (manual resistance, free weights, machines) Aerobic exercise: 2x / week (cycle ergometer, treadmill)\n\nDuration: 6-12 weeks', 'interventionNames': ['Other: Exercise', 'Other: Standard of Care']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Resistance and aerobic exercise in addition to standard of care rehabilitation', 'armGroupLabels': ['Exercise']}, {'name': 'Standard of Care', 'type': 'OTHER', 'description': 'Standard of care rehabilitation', 'armGroupLabels': ['Exercise', 'Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430060', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xie Weiguo', 'role': 'CONTACT', 'email': 'wgxie@hotmail.com', 'phone': '+8618071085225'}], 'facility': 'Institute of Burns, Wuhan Third Hospital & Tongren Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'David R Schieffelers', 'role': 'CONTACT', 'email': 'david.schieffelers@uantwerp.be', 'phone': '+32465419848'}], 'overallOfficials': [{'name': 'Ulrike Van Daele', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine and Health Sciences, University of Antwerp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Datasets will be made available upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiteit Antwerpen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Research Foundation Flanders', 'class': 'OTHER'}, {'name': 'Wuhan Third Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. dr.', 'investigatorFullName': 'Ulrike Van Daele', 'investigatorAffiliation': 'Universiteit Antwerpen'}}}}