Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 11:37 PM
Study NCT ID:
NCT07205393
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase One Cardiac Rehabilitation Outcomes Post Valve Replacement 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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2025-09-23', 'studyFirstSubmitQcDate': '2025-09-30', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygen saturation.', 'timeFrame': '5 to 6 days', 'description': 'Oxygen saturation: (2700 Branshaj, Denemark).'}, {'measure': 'FVC', 'timeFrame': '5 to 6 days', 'description': 'Forced vital capacity (FVC)'}, {'measure': 'FEV1', 'timeFrame': '5 to 6 days', 'description': 'forced expiratory volume in the first second (FEV1)'}, {'measure': 'FEV1/FVC.', 'timeFrame': '5 to 6 days', 'description': 'The ratio of FEV1 on FVC.'}], 'secondaryOutcomes': [{'measure': 'The 6-Minute Walk Test (6MWT)', 'timeFrame': '5 to 6 days', 'description': 'The 6-Minute Walk Test (6MWT): We performed the 6-minute walking test (6MWT), which involved measurement of the 6-minute walking distance and is a submaximal functional test indicative of performing daily activities.18 The safety and feasibility of this test have led to its use in cardiovascular rehabilitation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac rehabilitation', 'Valve replacement', 'Spirometry measures'], 'conditions': ['Valve Replacement Surgery']}, 'descriptionModule': {'briefSummary': 'Cardiac rehabilitation is a crucial component of postoperative recovery for patients who have received valve replacement surgery. Aim: This study aimed to evaluate the effectiveness of phase one cardiac rehabilitation in improving cardiovascular function, pulmonary capacity, functional ability, and quality of life.', 'detailedDescription': 'A 60 patients aged 40 to 60 years who had received mitral or aortic valve replacement were allocated randomly into two groups equal in numbers, the first one (cardiac rehabilitation group) participated in a phase one cardiac rehabilitation program comprising supervised physical exercises and respiratory training, the second one (control group) underwent routine physical therapy program. The outcomes were oxygen saturation measurements, spirometry measures and Six minutes walk test. All measured variables were evaluated before and after six consecutive weeks of rehabilitation for all patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The inclusion criteria was elective mitral or aortic valve replacement\n* and to be hemodynamically stable to qualify for a structured rehabilitation program.\n* Being able to understand and complete measurements.\n* And provide informed written consent.\n\nExclusion Criteria:\n\n* Patient with ischemic heart disease before surgery.\n* Those with severe musculoskeletal system disorders.\n* Patients who had persistent or paroxysmal atrial fibrillation.\n* Individuals with severe heart failure.\n* uncontrolled arrhythmias.\n* Comorbidity complicating physical activity or other contraindications to phase one cardiac rehabilitation and Patients who underwent an emergency surgical intervention.'}, 'identificationModule': {'nctId': 'NCT07205393', 'briefTitle': 'Phase One Cardiac Rehabilitation Outcomes Post Valve Replacement Surgery', 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': 'Phase One Cardiac Rehabilitation Outcomes Post Valve Replacement Surgery', 'orgStudyIdInfo': {'id': 'P.T_INT_11/2024_553'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cardiac rehabilitation', 'description': 'The intervention group underwent the cardiac rehabilitation program from the first day following surgery regarding the clinical guideline for rehabilitation in patients with cardiovascular disease.17 This rehabilitation exercise program formed of breathing exercises, lower and upper extremity exercises in bed, sitting on the edge of the bed, standing at the bedside, and walking around the bed and for 100 m in the ward. The patient performed three sessions per day, with approximately 20 minutes each time. After the rehabilitation exercise, patients continued with gait practice for up to 500 m and carried out endurance training by using a stationary bike in the rehabilitation center of the hospital.\n\nThe sessions continued until they were discharged from the hospital (approximately 5 to 6 days post operative). The intensity of physical activity was limited by clinical conditions and activity tolerance, and monitored and assessed by physical therapists, plus routine clinical care.', 'interventionNames': ['Other: Cardiac rehabilitation', 'Other: Routine clinic care']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'The control group did not joined any rehabilitation program and only received routine clinical care during the duration of the hospital stay (approximately 5 to 6 days post operative).\n\nData collection The investigators assessed all patients on the day before surgery (baseline assessment) and the day of hospital discharge.', 'interventionNames': ['Other: Routine clinic care']}], 'interventions': [{'name': 'Cardiac rehabilitation', 'type': 'OTHER', 'description': 'The intervention group underwent the cardiac rehabilitation program from the first day following surgery regarding the clinical guideline for rehabilitation in patients with cardiovascular disease.17 This rehabilitation exercise program formed of breathing exercises, lower and upper extremity exercises in bed, sitting on the edge of the bed, standing at the bedside, and walking around the bed and for 100 m in the ward. The patient performed three sessions per day, with approximately 20 minutes each time. After the rehabilitation exercise, patients continued with gait practice for up to 500 m and carried out endurance training by using a stationary bike in the rehabilitation center of the hospital.\n\nThe essions continued until they were discharged from the hospital (approximately 5 to 6 days post operative). The intensity of physical activity was limited by clinical conditions and activity tolerance, and monitored and assessed by physical therapists. Plus routine clinical care', 'armGroupLabels': ['Cardiac rehabilitation']}, {'name': 'Routine clinic care', 'type': 'OTHER', 'description': 'The control group did not joined any rehabilitation program and only received routine clinical care during the duration of the hospital stay (approximately 5 to 6 days post operative).', 'armGroupLabels': ['Cardiac rehabilitation', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Qina', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Shymaa Yussuf Abo_Zaid, Lecturer', 'role': 'CONTACT', 'email': 'shaymaayoussef397@gmail.com', 'phone': '01010941685'}], 'facility': 'South valley university', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}], 'centralContacts': [{'name': 'Shymaa Yussuf Abo-Zaid, Lecturer', 'role': 'CONTACT', 'email': 'shaymaayoussef397@gmail.com', 'phone': '01010941685'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'I will not share it outside the primary research group.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Shymaa yussuf abo zaid', 'investigatorAffiliation': 'South Valley University'}}}}