Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-02-25 @ 8:17 PM
Study NCT ID:
NCT05315193
Status:
COMPLETED
Last Update Posted:
2023-05-18
First Post:
2022-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Exercise Training in Coronary Artery Disease Patients After Stenting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-17', 'studyFirstSubmitDate': '2022-03-30', 'studyFirstSubmitQcDate': '2022-03-30', 'lastUpdatePostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ankle-brachial index', 'timeFrame': '12 weeks', 'description': 'Changes From the Baseline,6th week and 12 weeks, measured through the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial artery to detect Peripheral Artery Disease. Normal Ankle-brachial index ranges from 1.0 to 1.4.'}, {'measure': 'Quality of life index cardiac version -IV', 'timeFrame': '12 weeks', 'description': 'Changes From the Baseline, 6th week and 12 weeks measured through Quality of life index cardiac version -IV. It consists of 70 items. Each item used a six-point Likert rating scale. Scores calculated for overall quality of life in four domains: health and functioning (15 items), social and economic (8 items), psychological/spiritual (7 items), and family (5 items). High scores indicated a better quality of life.'}], 'secondaryOutcomes': [{'measure': 'Dyspnea', 'timeFrame': '3-5 days', 'description': 'Changes From the Baseline, measured through Rose Dyspnea Scale. The scale consists of four items, with scores ranging from 0 to 4, where 0 indicates no dyspnea with activity, and increasing scores indicate greater limitations because of dyspnea.'}, {'measure': 'Rate of perceived exertion (RPE)', 'timeFrame': '12 weeks', 'description': "Changes From the Baseline,6th week and 12 weeks, measured through Borg RPE scale which measures a person's perception of their effort and exertion breathlessness, and fatigue during physical work rating between 6 and 20. The higher the number, the more intense the exercise. An RPE of 6 is often referred to as just above rest, hardly any exertion, while an RPE of 20 is a maximal effort."}, {'measure': 'Forced Expiratory Volume in 1 second (FEV1)', 'timeFrame': '12 weeks', 'description': 'Changes from the Baseline,6th week and 12 weeks, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters'}, {'measure': 'Forced vital Capacity (FVC)', 'timeFrame': '12 weeks', 'description': 'Changes From the Baseline,6th week and 12 weeks, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ankle-Brachial Index', 'Coronary artery diseases', 'Exercise training', 'Quality of life', 'Stenting'], 'conditions': ['Stent Restenosis', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': "To determine the effects of exercise training on ankle-brachial index and Quality of Life in coronary artery disease patients after stenting. There is a need to develop strategies, not only to prevent restenosis but also to improve patients' functional status and perception of well-being. In particular, it is not well defined whether exercise training can reduce the restenosis rate and improve the outcome after percutaneous intervention (PCI), and its effects on the Ankle-brachial index are not yet well known.", 'detailedDescription': 'The existence of PAD in patients with Coronary artery disease (CAD) remarkably increases the risk of cardiovascular morbidity and mortality. Almost half of the patients, after an initial encouraging improvement in functional capacity and quality of life (QOL) after the PCI, deal with recurrent chest pain that requires medical attention, reduces functional capacity, and creates a status of psychological distress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* GCS = 15\n* Disease chronicity: 1-3 years Elective / stenting procedure\n* Single or Double vessel stunting EF: 35 above\n\nExclusion Criteria:\n\n* Unwilling to participate in research\n* Known cases of Uncontrolled DM or HTN\n* Known cases of Cognitive/memory/neurological disorders\n* Known cases of any Systemic disease'}, 'identificationModule': {'nctId': 'NCT05315193', 'briefTitle': 'Effect of Exercise Training in Coronary Artery Disease Patients After Stenting', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Exercise Training on Ankle-brachial Index and Quality of Life in Coronary Artery Disease Patients After Stenting.', 'orgStudyIdInfo': {'id': 'Rec/01279 Umair Ahmad'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Structured In-patient and Home plan', 'description': 'Structured In-patient and Home plan', 'interventionNames': ['Other: Structured In-patient and Home plan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Conventional therapy', 'description': 'Conventional protocol as per guidelines', 'interventionNames': ['Other: Conventional Therapy']}], 'interventions': [{'name': 'Structured In-patient and Home plan', 'type': 'OTHER', 'description': 'A patient education session and a protocol comprise of 3 days. It consists of three different levels having progressive activities. The in-patient protocol will start from the day of the procedure. Each level contains 2 to 6 tasks, performed in sets of 5-10 repetitions 3 times a day. Home plan: Walking 3 days a week starting from normal pace ((RPE: 8-9) for10 minutes and progressively increased intensity and duration over the period of 12 weeks (RPE: 13-14).', 'armGroupLabels': ['Structured In-patient and Home plan']}, {'name': 'Conventional Therapy', 'type': 'OTHER', 'description': 'In-Patient: Wound care, Bed mobility:\n\nAROMS (10 Reps\\*3sets\\*TD), Breathing Exercise (10 Reps\\*3sets\\*TD), Mobilization (Walk as per patient tolerance) Patient Education: To keep the heart healthy Diet Avoid strenuous exercise and lifting heavy objects Avoid valsalva manure, Quit smoking Lower cholesterol levels, Maintain a healthy weight Control other conditions, such as diabetes and high blood pressure Take medications as prescribed by your doctor Get regular exercise: Walking at a normal pace as per tolerance (RPE up to 10)', 'armGroupLabels': ['Conventional therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Peshawar', 'state': 'KPK', 'country': 'Pakistan', 'facility': 'Peshawar Institute of cardiology', 'geoPoint': {'lat': 34.008, 'lon': 71.57849}}], 'overallOfficials': [{'name': 'Mehwish Waseem, MSPT(CPPT)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}