Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-01 @ 2:12 PM
Study NCT ID:
NCT06293092
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2024-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intradialytic Exercises in Chronic Kidney Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'control group receive medical treatment only ,first study group receive medical treatment and intradialytic aerobic exercise , second study group receive medical treatment and intradialytic resistive exercise'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-01', 'studyFirstSubmitDate': '2024-02-13', 'studyFirstSubmitQcDate': '2024-03-01', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of immunoglobulin g', 'timeFrame': 'baseline , 12 weeks for each patient', 'description': 'measured by mg/dl'}, {'measure': 'Total leukocyte count', 'timeFrame': 'baseline , 12 weeks for each patient', 'description': 'measured by (cell/mcl)\\*\\*\\*\\*1000'}, {'measure': 'lymphocyte count', 'timeFrame': 'baseline , 12 weeks for each patient', 'description': 'measured by (cell/mcl)\\*\\*\\*\\*1000'}, {'measure': 'neutrophil count', 'timeFrame': 'baseline , 12 weeks for each patient', 'description': 'measured by (cell/mcl)\\*\\*\\*\\*1000'}, {'measure': 'Concentration of HbA1c', 'timeFrame': 'baseline , 12 weeks for each patient', 'description': 'measured by percentage of blood sugar last 3 months'}], 'secondaryOutcomes': [{'measure': 'hemoglobin concentration', 'timeFrame': 'baseline , 12 weeks for each patient', 'description': 'measured by (g/dl)'}, {'measure': 'thrombocytes count', 'timeFrame': 'baseline , 12 weeks for each patient', 'description': 'measured by (cell/mcl)\\*\\*\\*\\*1000'}, {'measure': 'diastolic blood pressure', 'timeFrame': 'baseline , 12 weeks for each patient', 'description': 'measured by mmHg'}, {'measure': 'Systolic blood pressure', 'timeFrame': 'baseline , 12 weeks for each patient', 'description': 'measured by mmHg'}, {'measure': 'six minute walk test', 'timeFrame': 'baseline , 12 weeks for each patient', 'description': 'measured by meter'}, {'measure': '(KDQOL-SFTM) questionnaire', 'timeFrame': 'baseline , 12 weeks for each patient', 'description': 'measured by scoring a score-value from 0 (worst health status) to 100 (best health status) was obtained'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Dialysis', 'Kidney Failure', 'Chronic'], 'conditions': ['Chronic Kidney Disease stage3']}, 'descriptionModule': {'briefSummary': 'the purpose of this study is to compare between intradialytic aerobic versus resistive exercises on immunity response in patients with chronic kidney disease.', 'detailedDescription': 'The patients of this study will randomly assigned into three equal groups (n=20)\n\n1. Study Group A (20 patients) will receive intradialytic aerobic exercise and medical treatment.\n2. Study Group B (20 patients) will receive intradialytic resistive exercise and medical treatment.\n3. Control Group C (20 patients) will receive medical treatment only (HD session and drugs) Each patient will receive the treatment program three times per week for three months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sixty men chronic kidney disease (grade III RF). They received regular hemodialysis sessions at least one year ago, each one for four hours, three times per week.\n* They had a history of type II Diabetes more than five years.\n* Their age will be ranged from 50-60 years old.\n* They are Fit for exercise by functional assessment using six minute walk test.\n* Their Hemoglobin level more than 10 g\\\\dl.\n* Their Body Mass Index (BMI) will be ranged from "18.5" to "24.9".\n\nExclusion Criteria:\n\n* Severe cardiac disorders.\n* Severe orthopedic problems (for example fractures).\n* Hepatic encephalopathy.\n* Preexisting neuromuscular diseases (e.g. myasthenia gravis). •Severe chest diseases.\n* Spinal cord injuries involved the phrenic nerve.\n* Uncontrolled diabetes or hypertension\n* Patients receiving inefficient hemodialysis session.\n* Patients with other cause for inflammation e.g. malignancy and autoimmune disease.\n* Active bleeding as alveolar hemorrhage, hemoptysis.\n* Physical limitation that would limit cycling.'}, 'identificationModule': {'nctId': 'NCT06293092', 'briefTitle': 'Effect of Intradialytic Exercises in Chronic Kidney Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Intradialytic Aerobic Versus Resistive Exercises on Immunity Response in Patients With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'control group C', 'description': 'receive hemodialysis sessions', 'interventionNames': ['Device: hemodialysis sessions']}, {'type': 'EXPERIMENTAL', 'label': 'study group A aerobic exercise', 'description': 'receive hemodialysis sessions and intradialytic aerobic exercise', 'interventionNames': ['Device: leg pedaling cycling device', 'Device: hemodialysis sessions']}, {'type': 'EXPERIMENTAL', 'label': 'study group B resistive exercise', 'description': 'receive hemodialysis sessions and intradialytic resistive exercise', 'interventionNames': ['Device: sand bags', 'Device: hemodialysis sessions']}], 'interventions': [{'name': 'leg pedaling cycling device', 'type': 'DEVICE', 'description': 'Intradialytic aerobic cycling exercise program ,each patient will receive the treatment program three times per week for three months.', 'armGroupLabels': ['study group A aerobic exercise']}, {'name': 'sand bags', 'type': 'DEVICE', 'description': 'Intradialytic resistive exercise program , each patient will receive the treatment program three times per week for three months.', 'armGroupLabels': ['study group B resistive exercise']}, {'name': 'hemodialysis sessions', 'type': 'DEVICE', 'description': 'hemodialysis sessions ,each patient will receive the treatment program three times per week for three months.', 'armGroupLabels': ['control group C', 'study group A aerobic exercise', 'study group B resistive exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Fayyum', 'country': 'Egypt', 'facility': 'Fayoum hospital', 'geoPoint': {'lat': 29.30995, 'lon': 30.8418}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'physiotherapist', 'investigatorFullName': 'Hazem Mohamed Yasin Abbas', 'investigatorAffiliation': 'Cairo University'}}}}