Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-25 @ 5:00 PM
Study NCT ID:
NCT07176403
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Intradialytic Exercise on Sleep, Depression and Anxiety in HD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will include seventy patients maintained on regular hemodialysis in Alexandria University Hospitals.\n\nPatients will be divided into two groups:\n\nGroup (A): 50 patients will perform exercise during hemodialysis session. Group (B): 50 patients will not be assigned to any exercise program (as a control group).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2025-09-09', 'studyFirstSubmitQcDate': '2025-09-09', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in sleep quality', 'timeFrame': '12 weeks', 'description': 'by using The Pittsburgh sleep Quality Index (PSQI).'}, {'measure': 'change in depression scale', 'timeFrame': '12 weeks', 'description': 'by using Beck Depression inventory (BDI)'}, {'measure': 'change in anxiety level', 'timeFrame': '12 weeks', 'description': 'by using The Beck Anxiety Inventory (BAI) scoring'}], 'secondaryOutcomes': [{'measure': 'effect on dialysis adequacy', 'timeFrame': '12 weeks', 'description': 'by assessing urea reduction ratio (URR)'}, {'measure': 'effect on lipid profile', 'timeFrame': '12 weeks', 'description': 'by assessing triglycerides and cholesterol'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intradialytic exercise', 'sleep', 'depression', 'anxiety', 'hemodialysis'], 'conditions': ['Intradialytic Exercise']}, 'referencesModule': {'references': [{'pmid': '22111062', 'type': 'BACKGROUND', 'citation': 'Jung TD, Park SH. Intradialytic exercise programs for hemodialysis patients. Chonnam Med J. 2011 Aug;47(2):61-5. doi: 10.4068/cmj.2011.47.2.61. Epub 2011 Aug 31.'}, {'pmid': '26997387', 'type': 'BACKGROUND', 'citation': 'Rajan EJ, Subramanian S. The effect of depression and anxiety on the performance status of end-stage renal disease patients undergoing hemodialysis. Saudi J Kidney Dis Transpl. 2016 Mar;27(2):331-4. doi: 10.4103/1319-2442.178555.'}, {'pmid': '26163057', 'type': 'BACKGROUND', 'citation': 'Mollayeva T, Thurairajah P, Burton K, Mollayeva S, Shapiro CM, Colantonio A. The Pittsburgh sleep quality index as a screening tool for sleep dysfunction in clinical and non-clinical samples: A systematic review and meta-analysis. Sleep Med Rev. 2016 Feb;25:52-73. doi: 10.1016/j.smrv.2015.01.009. Epub 2015 Feb 17.'}, {'pmid': '22923917', 'type': 'BACKGROUND', 'citation': 'Gordon L, McGrowder DA, Pena YT, Cabrera E, Lawrence-Wright M. Effect of exercise therapy on lipid parameters in patients with end-stage renal disease on hemodialysis. J Lab Physicians. 2012 Jan;4(1):17-23. doi: 10.4103/0974-2727.98665.'}]}, 'descriptionModule': {'briefSummary': 'this study aims To assess the effect of intradialytic exercise program on sleep quality, depression and anxiety in HD Patients.', 'detailedDescription': 'Intradialytic exercise is a common recommendation given to encourage patients to be physically active. Previous studies have suggested that intradialytic exercise is effective in reducing fatigue severity, improving sleep quality, enhancing exercise tolerance, improving quality of life and even psychological status. Research also revealed that intradialytic exercise can increase the efficacy of dialysis, subsequently alleviating inflammation, improving nutrition and bone mineral density. Patients typically undergo two or three hemodialysis sessions a week, with each session lasting for approximately 4 hours. Since many patients maintain bed rest during HD sessions, intradialytic exercise can be a potentially useful approach to improve their health without consuming extra time during the interdialytic period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ESKD patients on maintenance hemodialysis for more than three months.\n2. Age more than 18 years.\n\nExclusion Criteria:\n\n1. Mentally or physically unfit patients or with severe psychiatric illness.\n2. Patients who receive any psychotropic medications.\n3. Patients with overt ischemic heart disease or cardiac decompensation.\n4. Anemic patients (Hb ≤ 8 mg/dl).\n5. Patients presented with severe bone pains or muscle weakness secondary to chronic kidney disease-mineral and bone disorder (CKD-MBD).\n6. Patients with advanced lower limbs joints disease.\n7. Lower limb amputation.'}, 'identificationModule': {'nctId': 'NCT07176403', 'briefTitle': 'Effect of Intradialytic Exercise on Sleep, Depression and Anxiety in HD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Effect of Intradialytic Exercise Program on Sleep Quality, Depression and Anxiety in Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'exercise effect on HD patients'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise group', 'description': '50 patients will undergo Exercise training program for twelve weeks during hemodialysis session.\n\n1. Type of exercise: aerobic exercise training sessions using a lower limb ergometer.\n2. Frequency: three times per week.\n3. Duration: thirty minutes per session.', 'interventionNames': ['Other: intradialytic exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': '50 patients will not perform exercise during hemodialysis session', 'interventionNames': ['Other: control group']}], 'interventions': [{'name': 'intradialytic exercise', 'type': 'OTHER', 'description': '50 patients will undergo Exercise training program for twelve weeks during hemodialysis session.\n\n1. Type of exercise: aerobic exercise training sessions using a lower limb ergometer.\n2. Frequency: three times per week.\n3. Duration: thirty minutes per session.', 'armGroupLabels': ['Exercise group']}, {'name': 'control group', 'type': 'OTHER', 'description': '50 patients will not perform exercise during hemodialysis session', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21526', 'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'mohamed mamdouh elsayed, MD', 'role': 'CONTACT', 'email': 'dr_mohamedmamdouh87@yahoo.com', 'phone': '00201068055103'}], 'facility': 'Faculty of Medicine, Aexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Mohamed mamdouh Elsayed, MD', 'role': 'CONTACT', 'email': 'dr_mohamedmamdouh87@yahoo.com', 'phone': '00201068055103'}], 'overallOfficials': [{'name': 'Mohamed mamdouh Elsayed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate professor'}, {'name': 'Iman Ezzat Elgohary, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'professor'}, {'name': 'Marwa Mohamed Hassan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'professor'}, {'name': 'Heba Essam Abou EL wafa, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'professor'}, {'name': 'Raghda Ashraf AboTawila, MBBCh', 'role': 'STUDY_CHAIR', 'affiliation': 'resident'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD', 'investigatorAffiliation': 'Alexandria University'}}}}