Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 10:54 PM
Study NCT ID:
NCT05932134
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2023-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
High Protein, Core Muscle Rehab, Muscular Electrostimulation in Prolonged Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011488', 'term': 'Protein Deficiency'}], 'ancestors': [{'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073600', 'term': 'Diet, High-Protein'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pitiful1984@gmail.com', 'phone': '+886-3-3281200', 'title': 'M.D', 'phoneExt': '8467', 'organization': 'Linkou Chang Gung Memorial Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': "First, our trial is a single-center trial made in RCC. The nutritional protocol, interventions were not blinded to the staff, which may possibly introduce bias. Moreover, we calculated caloric intake and protein intake using body weight as ESPEN guideline. We didn't use calorimetry to predict precisely energy consumption. The nutrition need might be not adequate for patients. This study enrolled relatively small number of subjects in each group, which may limit the validity."}}, 'adverseEventsModule': {'timeFrame': 'from enrollment through the end of the admission, up to 3 months', 'description': "adverse event defined as related to the intervention. If the mortality was not happened during intervention period or directly related to the intervention, it's not defined as adverse events of this study.", 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care', 'description': 'Usual care as RCC protocol in Chang Gung Memorial hospital', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'UC + High Protein Diet (HP)', 'description': 'The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 5, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'UC + HP + Core Muscle Rehabilitation', 'description': 'Protein provision was not reduced in case of renal failure. Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 5, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'UC + HP + Core Muscle Rehabilitation + Neuromuscular Electric Stimulation (NMES)', 'description': 'NMES was applied for 30 min, twice per day, 5 days per week, for 3 weeks via surface rectangular electrodes. Electrodes were placed on back designed to activate latissimus dorsi and abdominal wall designed to activate the transversus abdominis and internal and external oblique muscles. Electrical muscle stimulation was performed by using a commercial stimulator (GEMORE, GM300E, Taipei, Taiwan) with biphasic waves at a simulation frequency of 30 Hz and pulse width of 400s, cycling 2s on and 4s off. Electrical muscle stimulation intensity was gradually increased until a visible muscle contraction was observed (median 60 mA \\[range 50-65 mA\\].', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 4, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Weaning Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual care', 'description': 'Usual care as RCC protocol in Chang Gung Memorial hospital'}, {'id': 'OG001', 'title': 'UC + high protein diet (HP)', 'description': 'The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.'}, {'id': 'OG002', 'title': 'UC + HP + core muscle rehabilitation', 'description': 'Protein provision was not reduced in case of renal failure. Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks.'}, {'id': 'OG003', 'title': 'UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)', 'description': 'NMES was applied for 30 min, twice per day, 5 days per week, for 3 weeks via surface rectangular electrodes. Electrodes were placed on back designed to activate latissimus dorsi and abdominal wall designed to activate the transversus abdominis and internal and external oblique muscles. Electrical muscle stimulation was performed by using a commercial stimulator (GEMORE, GM300E, Taipei, Taiwan) with biphasic waves at a simulation frequency of 30 Hz and pulse width of 400s, cycling 2s on and 4s off. Electrical muscle stimulation intensity was gradually increased until a visible muscle contraction was observed (median 60 mA \\[range 50-65 mA\\].'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'weaning success defined as weaning from ventilator for 5 consecutive days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'In Hospital Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual care', 'description': 'Usual care as RCC protocol in Chang Gung Memorial hospital'}, {'id': 'OG001', 'title': 'UC + high protein diet (HP)', 'description': 'The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.'}, {'id': 'OG002', 'title': 'UC + HP + core muscle rehabilitation', 'description': 'Protein provision was not reduced in case of renal failure. Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks.'}, {'id': 'OG003', 'title': 'UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)', 'description': 'NMES was applied for 30 min, twice per day, 5 days per week, for 3 weeks via surface rectangular electrodes. Electrodes were placed on back designed to activate latissimus dorsi and abdominal wall designed to activate the transversus abdominis and internal and external oblique muscles. Electrical muscle stimulation was performed by using a commercial stimulator (GEMORE, GM300E, Taipei, Taiwan) with biphasic waves at a simulation frequency of 30 Hz and pulse width of 400s, cycling 2s on and 4s off. Electrical muscle stimulation intensity was gradually increased until a visible muscle contraction was observed (median 60 mA \\[range 50-65 mA\\].'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'through the end of admission, up to 3 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Mechanical Ventilator Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual care', 'description': 'Usual care as RCC protocol in Chang Gung Memorial hospital'}, {'id': 'OG001', 'title': 'UC + high protein diet (HP)', 'description': 'The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.'}, {'id': 'OG002', 'title': 'UC + HP + core muscle rehabilitation', 'description': 'Protein provision was not reduced in case of renal failure. Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks.'}, {'id': 'OG003', 'title': 'UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)', 'description': 'NMES was applied for 30 min, twice per day, 5 days per week, for 3 weeks via surface rectangular electrodes. Electrodes were placed on back designed to activate latissimus dorsi and abdominal wall designed to activate the transversus abdominis and internal and external oblique muscles. Electrical muscle stimulation was performed by using a commercial stimulator (GEMORE, GM300E, Taipei, Taiwan) with biphasic waves at a simulation frequency of 30 Hz and pulse width of 400s, cycling 2s on and 4s off. Electrical muscle stimulation intensity was gradually increased until a visible muscle contraction was observed (median 60 mA \\[range 50-65 mA\\].'}], 'classes': [{'categories': [{'measurements': [{'value': '74.4', 'spread': '27.1', 'groupId': 'OG000'}, {'value': '56.5', 'spread': '24.1', 'groupId': 'OG001'}, {'value': '57.1', 'spread': '29.9', 'groupId': 'OG002'}, {'value': '41.1', 'spread': '12.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'total ventilator use days in this admission', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of ICU Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual care', 'description': 'Usual care as RCC protocol in Chang Gung Memorial hospital'}, {'id': 'OG001', 'title': 'UC + high protein diet (HP)', 'description': 'The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.'}, {'id': 'OG002', 'title': 'UC + HP + core muscle rehabilitation', 'description': 'Protein provision was not reduced in case of renal failure. Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks.'}, {'id': 'OG003', 'title': 'UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)', 'description': 'NMES was applied for 30 min, twice per day, 5 days per week, for 3 weeks via surface rectangular electrodes. Electrodes were placed on back designed to activate latissimus dorsi and abdominal wall designed to activate the transversus abdominis and internal and external oblique muscles. Electrical muscle stimulation was performed by using a commercial stimulator (GEMORE, GM300E, Taipei, Taiwan) with biphasic waves at a simulation frequency of 30 Hz and pulse width of 400s, cycling 2s on and 4s off. Electrical muscle stimulation intensity was gradually increased until a visible muscle contraction was observed (median 60 mA \\[range 50-65 mA\\].'}], 'classes': [{'categories': [{'measurements': [{'value': '31.3', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '25.7', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '26.0', 'spread': '8.3', 'groupId': 'OG002'}, {'value': '23.7', 'spread': '7.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'total ICU stay in this admission', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'Usual care as RCC protocol in Chang Gung Memorial hospital'}, {'id': 'FG001', 'title': 'UC + High Protein Diet (HP)', 'description': 'The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.'}, {'id': 'FG002', 'title': 'UC + HP + Core Muscle Rehabilitation', 'description': 'Protein provision was not reduced in case of renal failure. Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks.'}, {'id': 'FG003', 'title': 'UC + HP + Core Muscle Rehabilitation + Neuromuscular Electric Stimulation (NMES)', 'description': 'NMES was applied for 30 min, twice per day, 5 days per week, for 3 weeks via surface rectangular electrodes. Electrodes were placed on back designed to activate latissimus dorsi and abdominal wall designed to activate the transversus abdominis and internal and external oblique muscles. Electrical muscle stimulation was performed by using a commercial stimulator (GEMORE, GM300E, Taipei, Taiwan) with biphasic waves at a simulation frequency of 30 Hz and pulse width of 400s, cycling 2s on and 4s off. Electrical muscle stimulation intensity was gradually increased until a visible muscle contraction was observed (median 60 mA \\[range 50-65 mA\\].'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The inclusion criteria were as follows: 1. age ≥ 20 year old, 2. latest 21 days after their admission into the ICU, using mechanical ventilator for more than 21 days , 3. stable clinical condition, 4. maximal inspiratory pressure (MIP) \\< 30mmHg, 5. under enteral nutrition (EN) via NG tube.\n\nWe obtained written informed consent from the patients or their legally acceptable surrogate.', 'preAssignmentDetails': 'According to the order of enrollment, patients will be randomly assigned into four groups: (1) Usual care (UC) + high protein diet (HP), (2) UC + HP + core muscle rehabilitation, (3) UC + HP + core muscle rehabilitation + neuromuscular electrostimulation (NMES) (4) UC. Patients were randomized accordingly using a table of random numbers and sealed envelopes. After randomization, on the first three day, we initiated interventions and maintained intervention for 21 days.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'Usual care as RCC protocol in Chang Gung Memorial hospital'}, {'id': 'BG001', 'title': 'UC + High Protein Diet (HP)', 'description': 'The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.'}, {'id': 'BG002', 'title': 'UC + HP + Core Muscle Rehabilitation', 'description': 'Protein provision was not reduced in case of renal failure. Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks.'}, {'id': 'BG003', 'title': 'UC + HP + Core Muscle Rehabilitation + Neuromuscular Electric Stimulation (NMES)', 'description': 'NMES was applied for 30 min, twice per day, 5 days per week, for 3 weeks via surface rectangular electrodes. Electrodes were placed on back designed to activate latissimus dorsi and abdominal wall designed to activate the transversus abdominis and internal and external oblique muscles. Electrical muscle stimulation was performed by using a commercial stimulator (GEMORE, GM300E, Taipei, Taiwan) with biphasic waves at a simulation frequency of 30 Hz and pulse width of 400s, cycling 2s on and 4s off. Electrical muscle stimulation intensity was gradually increased until a visible muscle contraction was observed (median 60 mA \\[range 50-65 mA\\].'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '72.8', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '69.3', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '67.2', 'spread': '12.1', 'groupId': 'BG002'}, {'value': '71.5', 'spread': '9.1', 'groupId': 'BG003'}, {'value': '69.7', 'spread': '11.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'We had analyze the difference of age between groups.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '59', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'We had analyze the sex ratio between groups.'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'modified Nutrition Risk in Critically ill (NUTRIC) score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '5.1', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '4.8', 'spread': '1.8', 'groupId': 'BG002'}, {'value': '5.4', 'spread': '1.8', 'groupId': 'BG003'}, {'value': '5.1', 'spread': '1.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'a scoring system for nutrition status evaluation in critical illness patients. (including age, APACHE II, SOFA, comorbidities, Days from hospital to ICU admission) 5-0 =\\>High Score (Associated with worse clinical outcomes (mortality, ventilation), These patients are the most likely to benefit from aggressive nutrition therapy.) 0-4 =\\>LOW Score (These patients have a low malnutrition risk)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'We analyze the mNUTRIC score (range 0-10) between groups.'}], 'populationDescription': 'A total 100 patients were enrolled.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-09', 'size': 1420652, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-12-10T21:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will randomly stratify into four groups: (1) Usual care (UC), (2) UC + high protein diet (HP), (3) UC + HP + core muscle rehabilitation, (4) UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES).\n\nResearchers will compare group 2,3,4 to control group (1, usual care) to see if high protein diet, core muscle rehabilitation, neuromuscular electric stimulation works.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2023-04-26', 'resultsFirstSubmitDate': '2025-05-22', 'studyFirstSubmitQcDate': '2023-07-05', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-15', 'studyFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weaning Rate', 'timeFrame': '3 months', 'description': 'weaning success defined as weaning from ventilator for 5 consecutive days'}], 'secondaryOutcomes': [{'measure': 'In Hospital Mortality', 'timeFrame': '3 months', 'description': 'through the end of admission, up to 3 months'}, {'measure': 'Length of Mechanical Ventilator Usage', 'timeFrame': '3 months', 'description': 'total ventilator use days in this admission'}, {'measure': 'Length of ICU Stay', 'timeFrame': '6 months', 'description': 'total ICU stay in this admission'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prolonged Mechanical Ventilation', 'Protein Deficiency']}, 'referencesModule': {'references': [{'pmid': '36297079', 'type': 'RESULT', 'citation': 'Huang SW, Lin HC, Chou YF, Lin TY, Lo CY, Huang HY, Fang YF, Hsieh MH, Lin SM, Lo YL, Hsieh MJ, Kao KC, Lin CY, Huang CC. The Impact of Higher Protein Intake in Patients with Prolonged Mechanical Ventilation. Nutrients. 2022 Oct 20;14(20):4395. doi: 10.3390/nu14204395.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn about in patients with prolong mechanical ventilation. This main questions aims to answer are:\n\n* High protein formula intake benefit in successful weaning from ventilator\n* Core muscle rehabilitation benefit in successful weaning from ventilator\n* neuromuscular electric stimulation benefit in successful weaning from ventilator\n\nParticipants will receive high protein diet, core muscle rehabilitation, neuromuscular electric stimulation (NMES).\n\nResearchers will compare patients with interventions to control group to see if high protein diet, core muscle rehabilitation, neuromuscular electric stimulation works.', 'detailedDescription': 'The investigator aims to investigate the efficacy of below list methods in patients with prolong mechanical ventilator:\n\n* High protein formula intake benefit in successful weaning from ventilator\n* Core muscle rehabilitation benefit in successful weaning from ventilator\n* neuromuscular electric stimulation benefit in successful weaning from ventilator\n\nParticipants will randomly stratify into four groups: (1) Usual care (UC), (2) UC + high protein diet (HP), (3) UC + HP + core muscle rehabilitation, (4) UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES).\n\nResearchers will compare group 2,3,4 to control group (1, usual care) to see if high protein diet, core muscle rehabilitation, neuromuscular electric stimulation works.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age ≥ 20 year old\n2. using mechanical ventilator for more than 21 days (including patients under tracheostomy or endotracheal tube)\n3. stable clinical condition, without using inotropic agent (arterial blood gas pH : 7.35-7.45, PaO2≥60 mm Hg at FiO2 40%, absence of signs and symptoms of uncontrolled infection, and hemodynamic stability)\n4. maximal inspiratory pressure (MIP) \\< 30mmHg\n5. under enteral nutrition (EN) via NG tube.\n\nExclusion Criteria:\n\n1. Acute infection and sepsis (fever up to 38.5 degree)\n2. Severe neuromuscular disease, or uncontrolled epilepsy\n3. Bony fracture or DVT history\n4. Wound over the abdomen\n5. Congestive heart failure with EF \\< 40% or using pacemaker\n6. BMI\\>35 kg/M2, or severe edema\n7. Patients with hepatic failure, rapid progressed malignancy, or pregnancy were also excluded.\n8. Under parenteral nutrition (PN)\n9. Use pacemaker'}, 'identificationModule': {'nctId': 'NCT05932134', 'briefTitle': 'High Protein, Core Muscle Rehab, Muscular Electrostimulation in Prolonged Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'The Effects of High Protein Supplementation, Core Muscle Rehabilitation and Neuromuscular Electrostimulation (NMES) Programs on Clinical Outcomes in Patients With Prolonged Mechanical Ventilation (PMV〕', 'orgStudyIdInfo': {'id': '202300154A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Usual care as RCC protocol in Chang Gung Memorial hospital'}, {'type': 'EXPERIMENTAL', 'label': 'UC + high protein diet (HP)', 'description': 'The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.', 'interventionNames': ['Dietary Supplement: UC + high protein diet (HP)']}, {'type': 'EXPERIMENTAL', 'label': 'UC + HP + core muscle rehabilitation', 'description': 'Protein provision was not reduced in case of renal failure. Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks.', 'interventionNames': ['Behavioral: UC + HP + core muscle rehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)', 'description': 'NMES was applied for 30 min, twice per day, 5 days per week, for 3 weeks via surface rectangular electrodes. Electrodes were placed on back designed to activate latissimus dorsi and abdominal wall designed to activate the transversus abdominis and internal and external oblique muscles. Electrical muscle stimulation was performed by using a commercial stimulator (GEMORE, GM300E, Taipei, Taiwan) with biphasic waves at a simulation frequency of 30 Hz and pulse width of 400s, cycling 2s on and 4s off. Electrical muscle stimulation intensity was gradually increased until a visible muscle contraction was observed (median 60 mA \\[range 50-65 mA\\].', 'interventionNames': ['Device: UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)']}], 'interventions': [{'name': 'UC + high protein diet (HP)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.', 'armGroupLabels': ['UC + high protein diet (HP)']}, {'name': 'UC + HP + core muscle rehabilitation', 'type': 'BEHAVIORAL', 'description': 'Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks', 'armGroupLabels': ['UC + HP + core muscle rehabilitation']}, {'name': 'UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)', 'type': 'DEVICE', 'description': 'NMES was applied for 30 min, twice per day, 5 days per week, for 3 weeks via surface rectangular electrodes. Electrodes were placed on back designed to activate latissimus dorsi and abdominal wall designed to activate the transversus abdominis and internal and external oblique muscles. Electrical muscle stimulation was performed by using a commercial stimulator (GEMORE, GM300E, Taipei, Taiwan) with biphasic waves at a simulation frequency of 30 Hz and pulse width of 400s, cycling 2s on and 4s off. Electrical muscle stimulation intensity was gradually increased until a visible muscle contraction was observed (median 60 mA \\[range 50-65 mA\\].', 'armGroupLabels': ['UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Department of Thoracic Medicine, Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'Chun Yu Lin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}