Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-02-20 @ 6:39 PM
Study NCT ID:
NCT02778568
Status:
COMPLETED
Last Update Posted:
2016-05-25
First Post:
2013-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Cardiovascular Responses and Chronic Adaptations of Strength Exercise in Intermittent Claudication Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D007383', 'term': 'Intermittent Claudication'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'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': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-23', 'studyFirstSubmitDate': '2013-12-12', 'studyFirstSubmitQcDate': '2016-05-17', 'lastUpdatePostDateStruct': {'date': '2016-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood pressure', 'timeFrame': 'Change from baseline to 12 and 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in Walking distance', 'timeFrame': 'Change from baseline to 12 and 24 weeks'}, {'measure': 'Change in Health related Quality of life', 'timeFrame': 'Change from baseline to 12 and 24 weeksBaseline, 12 wks and 24 wks'}, {'measure': 'Change in Muscle blood flow of limbs', 'timeFrame': 'Change from baseline to 12 and 24 weeks', 'description': 'Muscle blood flow assessed with venous occlusion plethysmography'}, {'measure': 'Change in body fat', 'timeFrame': 'Change from baseline to 12 and 24 weeks'}, {'measure': 'Change Serum Cholesterol', 'timeFrame': 'Change from baseline to 12 and 24 weeks'}, {'measure': 'Change in serum glucose', 'timeFrame': 'Change from baseline to 12 and 24 weeks'}, {'measure': 'Change in TNFalpha', 'timeFrame': 'Change from baseline to 12 and 24 weeks'}, {'measure': 'Change in Score Short-physical performance battery', 'timeFrame': 'Change from baseline to 12 and 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Peripheral Artery Disease', 'Intermittent Claudication']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to analyze the effects of resistance exercise and training on cardiovascular function of peripheral artery disease patients.', 'detailedDescription': 'Several studies have shown that strength training can promote important benefits for the cardiovascular system in healthy subjects and patients with chronic diseases. However, the effects of resistance exercise on cardiovascular function in intermittent claudication patients are unclear. In addition, it also do not know the chronic effects on cardiovascular function in these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Had a graded treadmill test that was limited by claudication (2 minutes)\n* Had an ankle brachial index \\<0.90\n* Had systolic blood pressure ,160 mmHg and/or diastolic blood pressure,105 mmHg\n* Were not performing any regular exercise program\n* Were not using antihypertensive medications affecting the heart rate (e.g., b-blockers and nondihydropyridine calcium channel blockers)\n* Were nonobese\n* Individuals who have not undergone bypass surgery or angioplasty least one year ago\n\nExclusion Criteria:\n\n* Had no symptoms related to myocardial ischemia during the treadmill test\n* Amputation'}, 'identificationModule': {'nctId': 'NCT02778568', 'briefTitle': 'Acute Cardiovascular Responses and Chronic Adaptations of Strength Exercise in Intermittent Claudication Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Pernambuco'}, 'officialTitle': 'Acute Cardiovascular Responses and Chronic Adaptations of Strength Exercise in Intermittent Claudication Patients', 'orgStudyIdInfo': {'id': 'RMR2013FCPE MOVED'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resistance Training', 'description': 'Patients performed resistance exercises', 'interventionNames': ['Behavioral: Resistance training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Patients who performed flexibility exercise', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'Resistance training', 'type': 'BEHAVIORAL', 'otherNames': ['Physical training'], 'description': 'Resistance training exercises', 'armGroupLabels': ['Resistance Training']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Stretching exercises', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50100-060', 'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'facility': 'Emergency Hospital of Pernambuco - PROCAPE', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}], 'overallOfficials': [{'name': 'Marilia A Correia, MS', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Pernambuco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pernambuco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Ciência e Tecnologia de Pernambuco', 'class': 'OTHER'}, {'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Raphael M. Ritti Dias', 'investigatorAffiliation': 'University of Pernambuco'}}}}