Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-01-10 @ 9:33 PM
Study NCT ID:
NCT06490458
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2024-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Balance Training on Functional Capacity of Patients After Coronary Artery Bypass Grafting Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072038', 'term': 'Cardiac Rehabilitation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-30', 'studyFirstSubmitDate': '2024-06-30', 'studyFirstSubmitQcDate': '2024-06-30', 'lastUpdatePostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Berg balance scale(BBS)', 'timeFrame': '7 Days', 'description': '(0 indicating the lowest level ,4 indicating the highest level ) data about balance from BBS index.'}], 'secondaryOutcomes': [{'measure': 'sit to stand test(SST)in seconds', 'timeFrame': '1st day and 7th day', 'description': 'represent functional capacity (duration of 5 times sit to stand)'}, {'measure': 'length of hospital stay (in Days)', 'timeFrame': 'from 1st day', 'description': 'number of days spent in hospital'}, {'measure': 'SF36 Questionnaire( scores)', 'timeFrame': '3rd day', 'description': 'Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Bypass Graft Surgery(CABG)']}, 'descriptionModule': {'briefSummary': 'Background:There are still many gaps in research concerning the effect of balance training on functional capacity of patient after coronary artery bypass graft.\n\nAims: The purpose of this study was to examine the effect of balance training on patients after coronanry artery bypass graft surgery.', 'detailedDescription': 'Methods: Sixty male patients under went CABG with ages 55-65 years Patients were randomly randomized into to two groups equal in number 30 in each group. (Group A: study group, Group B: control group).All patients were thoroughly evaluated one day after extubation and day 6 after operation.\n\nBerg Balance Scale (BBS): is a test used to assess patients functional balance , the sit to stand test(STS) used to asses patients functional capacity and SF36 is questionnaire used to assess quality of life with patients. all of those tests done before and after training sessions with both groups. and compare the length of hospital stay between both groups.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '55 Years', 'genderBased': True, 'genderDescription': 'male patients their age ranged from 55 to 65', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Sixty male patients underwent CABG surgery, their age between 55 to 65 years old.\n2. All patients were conscious, clinically and medically stable.\n3. All patients are ambulant independently.\n4. All patients are haemodynamically stable.\n5. Good cognition level.\n6. All patients are conscious and can perform physical activity.\n\nExclusion Criteria:\n\n1. Hemodynamic instability.\n2. Patients who need re-intubation.\n3. Patients on high inotropic supports.\n4. Patients with existing pulmonary disease or associated pulmonary complications.\n5. Recent MI.\n6. Patients who reported too much pain.\n7. Neuromuscular disorders.\n8. Active hemorrhage and hemoptysis.\n9. Poor cognition and mentality.\n10. Unstable angina.\n11. Decompensated heart failure.\n12. Deep vein thrombosis.'}, 'identificationModule': {'nctId': 'NCT06490458', 'briefTitle': 'Effects of Balance Training on Functional Capacity of Patients After Coronary Artery Bypass Grafting Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effects of Balance Training Post Coronary Artery Bypass Grafting', 'orgStudyIdInfo': {'id': 'balance and cabg patients'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A :( Study group)', 'description': 'Underwent balance training and cardiac rehabilitation program for a duration of 25-30 min (total session) at a frequency of three times/week (every other day). The balance training was: a- Functional strength exercise b- Stance exercise c- Transition exercise D-Gait training e- Cardiac rehabilitation program .', 'interventionNames': ['Combination Product: Balance Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (control group)', 'description': 'underwent cardiac rehabilitation program only for a duration of 25-30 min (total session) at a frequency of three times/week (day after day).\n\nthe control group, received cardiac rehabilitation program only.', 'interventionNames': ['Combination Product: Balance Training']}], 'interventions': [{'name': 'Balance Training', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['cardiac rehabilitation'], 'description': 'Balance exercises and cardiac rehabilitation (intervention) for patients for 7 Days, 3 times/week for duration of 25-30 min/ session.', 'armGroupLabels': ['Group A :( Study group)', 'Group B (control group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11262', 'city': 'Giza', 'country': 'Egypt', 'facility': 'National heart institute', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Hady Balabel, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'after 1 month for 12 months', 'ipdSharing': 'YES', 'description': 'after approval can be shared', 'accessCriteria': 'will upload it to the journal of publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart Institute, Egypt', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecture of cardiopulmonary rehabilitation', 'investigatorFullName': 'Hady Atef Labib', 'investigatorAffiliation': 'Cairo University'}}}}