Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-25 @ 7:19 PM
Study NCT ID:
NCT06240832
Status:
COMPLETED
Last Update Posted:
2024-02-05
First Post:
2024-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aerobic Capacity Muscle Strength and Health Related Quality of Life in Children With Chronic Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058625', 'term': 'End Stage Liver Disease'}], 'ancestors': [{'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'One group of children ages more than 6ys will recruited and assessed pre and post of study completion for 12week'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-27', 'studyFirstSubmitDate': '2024-01-07', 'studyFirstSubmitQcDate': '2024-01-27', 'lastUpdatePostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'aerobic capacity', 'timeFrame': '8week', 'description': 'it was assessed by 6 minute walk test(6-MWT) in meter, The distance in meters was recorded at the end of the six minutes.'}, {'measure': 'grip strength', 'timeFrame': '8week', 'description': 'it was assessed by pneumatic hand held dynamometer ,was measured in pounds per square inch (PSI). The child was sitting on a chair with or without arm rest, back supported, and both feet rested on the floor. The right arm was beside the body, with adducted shoulder, elbow flexed 90°, forearm in neutral position, wrist from 0° to 30° extension, and 0° to 15° of ulnar deviation. Child was instructed to hold and compress the pneumatic handle of dynamometer as much strength as possible with the tested hand'}, {'measure': 'quadriceps strength', 'timeFrame': '8 week', 'description': 'it was assessed by Lafayette hand held dynamometer(LHHD)Child position was sitting on chair with back straight, hip and knee were in 90-degree flexion. LHHD was fixed on distal third of anterior surface of child leg while his/her tested thigh was stabilizing and then the child was instructed to perform maximal isometric knee extension and hold for 6 sec against LHHD sensor pad.'}, {'measure': 'health related quality of life', 'timeFrame': '8week', 'description': 'The Arabic version of child self-report Pediatric Quality of Life Inventory core scale version 4 (PedsQI) was used to assess HRQOL. PedsQI core scale designed to measure HRQOL in children and adolescents ages from 2 to18years. Each item of the questionnaire rated based on a rating scale from 0-4. Then, each item score was linearly converted on assessment scale from 0 to 100;0=100, 1=75, 2=50, 3=25, 4=0 then overall score calculated for all domains through dividing all answered items over whole number of items, with higher scores indicate a better HRQOL'}, {'measure': 'fatigue', 'timeFrame': '8 weeks', 'description': 'It was assessed by the PedsQI multidimensional fatigue scale version 3. It is composed of 3 domains; general fatigue, sleep/rest fatigue and cognitive fatigue,Each item score converted on a scale from 0 to 100: 0=100, 1=75, 2=50, 3=25, 4=0 then overall score calculated for all domains through dividing all answered items over whole number of items, with higher scores indicate lower level of fatigue'}], 'secondaryOutcomes': [{'measure': 'hemoglobin', 'timeFrame': '8week', 'description': 'A blood sample was taken for complete blood count (CBC )hemoglobin'}, {'measure': 'liver enzymes', 'timeFrame': '8week', 'description': 'A blood sample was taken for liver enzymes (Total bilirubin ,Direct bilirubin ) unit of measure (mg/dl)'}, {'measure': 'minerals', 'timeFrame': '8week', 'description': 'A blood sample was taken for minerals concentration (sodium Na,potassium K, magnissium M, calciumCa, posphorus P and create) unit of measure (mmol/l)'}, {'measure': 'mid upper arm circumference in centimeter', 'timeFrame': '8 weeks', 'description': 'assessed by tape measure,the tape was passed around the arm at the mid-point of the upper right arm halfway between the acromion process and the olecranon process'}, {'measure': 'triceps skin fold thickness', 'timeFrame': '8 weeks', 'description': 'it was assessed by holtain skinfold calipers in millimeter'}, {'measure': 'height in meter (m)', 'timeFrame': '8 weeks', 'description': 'assessed by stadiometre'}, {'measure': 'weight in kilogrms (Kg)', 'timeFrame': '8 weeks', 'description': 'assess by electronic scale'}, {'measure': 'body mass index', 'timeFrame': '8weeks', 'description': 'height/weight kg/m2'}, {'measure': 'mid upper muscle circumference', 'timeFrame': '8weeks', 'description': 'assessed by calculators that substract triceps skin fold thickness from mid upper arm circumference'}, {'measure': 'mid upper leg circumference in centimetre', 'timeFrame': '8 weeks', 'description': 'assessed by tape measure at mid -point between iliac crest and mid of patella'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aerobic capacity', 'chronic liver disease', 'muscle strength'], 'conditions': ['Chronic Liver Failure']}, 'referencesModule': {'references': [{'pmid': '24768811', 'type': 'RESULT', 'citation': 'Zenith L, Meena N, Ramadi A, Yavari M, Harvey A, Carbonneau M, Ma M, Abraldes JG, Paterson I, Haykowsky MJ, Tandon P. Eight weeks of exercise training increases aerobic capacity and muscle mass and reduces fatigue in patients with cirrhosis. Clin Gastroenterol Hepatol. 2014 Nov;12(11):1920-6.e2. doi: 10.1016/j.cgh.2014.04.016. Epub 2014 Apr 24.'}]}, 'descriptionModule': {'briefSummary': 'Physical therapy program for children with chronic liver disease consist of gait training, strengthening ex for UL\\&ll, stretching exercise to improve physical fitness and quality of life', 'detailedDescription': 'Intervention study for one group of children diagnosed with chronic liver disease ages more than 6ys, study include assessment and intervention, assessment of 6MWt, grip strength by hand held dynamometer, quadriceps strength by Lafayette, al children subjected to laboratory investigation pre and post of study completion, anthropometric measure, quality of life and fatigue assessment then all children will perform physical therapy program of gait training muscle strengthening for 8 week'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Their age ranged from7 to14 years old.\n* Residence in Cairo to be able to attend the rehabilitation program.\n* Diagnosis of CLD as (Wilson disease, autoimmune hepatitis, chronic cholestasis , ….etc).\n* All children were medically stabled\n* All children had the same socioeconomic status\n\nExclusion Criteria:\n\n* Complication that prevent children from performing maximal exercise test as fracture of both upper and lower limbs, cardiovascular instability and muscle disease in patient with glycogen storage disease(GSD) or abnormal creatine phosphokinase(CPK).\n* Patients with cognitive and motor disorders as in case of hepatic encephalopathy and or ascites.\n* Patients who underwent liver transplantation.\n* Patient with end stage liver disease.\n* History of variceal bleeding from one month ago or less.\n* No other system disease (chest, cardiac and nervous system).\n* Medical examination no hernia.'}, 'identificationModule': {'nctId': 'NCT06240832', 'briefTitle': 'Aerobic Capacity Muscle Strength and Health Related Quality of Life in Children With Chronic Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Aerobic Capacity Muscle Strength and Health Related Quality of Life in Children With Chronic Liver Disease', 'orgStudyIdInfo': {'id': 'P. T. REC/012/003479'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerobic and strength training in children with CLD', 'description': 'AEROBIC AND STRENGTHENING EXERCISE USING TREADMILL AND WEIGHT TO IMPROVE FUNCTIONAL OUTCOMES IN CHILDREN WITH CHRONIC LIVER DISEASE', 'interventionNames': ['Other: Physical therapy exercise']}], 'interventions': [{'name': 'Physical therapy exercise', 'type': 'OTHER', 'otherNames': ['Designated physical therapy program'], 'description': 'Endurance, strength and stretching training in Chronic liver disease children', 'armGroupLabels': ['Aerobic and strength training in children with CLD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Heba A IBRAHIM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer, pediatric department of physical therapy,principle investigator', 'investigatorFullName': 'Heba Ibrahim', 'investigatorAffiliation': 'Cairo University'}}}}