Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-02-23 @ 2:19 AM
Study NCT ID:
NCT02189018
Status:
COMPLETED
Last Update Posted:
2023-07-28
First Post:
2014-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Activity To Improve Outcomes in Peripheral Arterial Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C564658', 'term': 'Peripheral Arterial Occlusive Disease 1'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052580', 'term': 'Muscle Stretching Exercises'}], '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-26', 'studyFirstSubmitDate': '2014-07-10', 'studyFirstSubmitQcDate': '2014-07-11', 'lastUpdatePostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lower extremity perfusion', 'timeFrame': '6 months', 'description': 'Ankle brachial index and ultrasound quantification of muscle perfusion'}], 'secondaryOutcomes': [{'measure': 'Functional capacity', 'timeFrame': '6 months', 'description': 'Treadmill exercise testing'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Peripheral arterial disease', 'Endovascular', 'Exercise', 'Perfusion', 'Functional capacity'], 'conditions': ['Peripheral Arterial Occlusive Disease']}, 'descriptionModule': {'briefSummary': 'Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) in the legs and decreased blood flow to the legs. This may cause difficulty or pain with walking or other activities that use leg muscles. Exercise may help improve blood flow in the legs and improve the ability to walk. This research project is being implemented in adults with PAD to examine the effects of exercise or weight loss programs on lower extremity blood flow, health, and physical function.', 'detailedDescription': 'This pilot study seeks to gather data on different exercise interventions in PAD. Collectively, the proposed studies will gather data on the role of novel exercise interventions in those with PAD who are receiving conservative treatment as well as those who have undergone an endovascular intervention for lower extremity arterial disease.\n\nWe hypothesize that patients who undergo an exercise intervention will: A) show improved lower extremity perfusion and B) improve their functional ability, compared to a standard care control group over 6 months of follow-up. We further hypothesize that these improvements are mediated through angiogenesis and increased perfusion of the lower limb, as well as improvements in muscle strength, mass, and function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 21-90 years\n* Ankle brachial index \\< 0.9\n\nExclusion Criteria:\n\n* Cancer under active treatment, except prostate, skin, and hematologic cancers\n* Planned for open lower extremity bypass surgery\n* Body mass index \\>45\n* Lower extremity gangrene'}, 'identificationModule': {'nctId': 'NCT02189018', 'acronym': 'ACTION', 'briefTitle': 'Activity To Improve Outcomes in Peripheral Arterial Disease', 'organization': {'class': 'FED', 'fullName': 'Baltimore VA Medical Center'}, 'officialTitle': 'Activity To Improve Outcomes in Peripheral Arterial Disease', 'orgStudyIdInfo': {'id': 'HP-00059151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Ad lib activity at home', 'interventionNames': ['Other: Ad lib activity at home']}, {'type': 'EXPERIMENTAL', 'label': 'Active Exercise', 'description': 'Active exercise on treadmill', 'interventionNames': ['Other: Active Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Neuromuscular electrical stimulation', 'description': 'Neuromuscular electrical stimulation', 'interventionNames': ['Other: Neuromuscular electrical stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Weight loss and active exercise', 'description': 'Weight loss plus active exercise on treadmill', 'interventionNames': ['Other: Weight loss and active exercise']}], 'interventions': [{'name': 'Active Exercise', 'type': 'OTHER', 'description': 'Active exercise on a treadmill', 'armGroupLabels': ['Active Exercise']}, {'name': 'Neuromuscular electrical stimulation', 'type': 'OTHER', 'description': 'Neuromuscular electrical stimulation', 'armGroupLabels': ['Neuromuscular electrical stimulation']}, {'name': 'Weight loss and active exercise', 'type': 'OTHER', 'description': 'Weight loss and active exercise on a treadmill', 'armGroupLabels': ['Weight loss and active exercise']}, {'name': 'Ad lib activity at home', 'type': 'OTHER', 'description': 'Ad lib activity at home', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Baltimore VAMC', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Brajesh K Lal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baltimore VAMC, University of Maryland School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baltimore VA Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Brajesh K Lal', 'investigatorAffiliation': 'Baltimore VA Medical Center'}}}}