Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-03-15 @ 2:06 AM
Study NCT ID:
NCT02075502
Status:
COMPLETED
Last Update Posted:
2020-04-22
First Post:
2014-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community Walking Exercise for Patients With Peripheral Artery Disease
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': 'D005081', 'term': 'Exercise Therapy'}], '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': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-30', 'size': 211482, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-04-20T11:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-20', 'studyFirstSubmitDate': '2014-02-13', 'studyFirstSubmitQcDate': '2014-02-28', 'lastUpdatePostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in peak walking time (PWT)', 'timeFrame': 'Baseline, post-revascularization (ET or open intervention) (4 weeks, if applicable), post-12 weeks (exercise and control groups), 6 months following intervention time period'}], 'secondaryOutcomes': [{'measure': 'Change in claudication onset time (COT)', 'timeFrame': 'Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period'}, {'measure': 'Change in patient-reported outcomes', 'timeFrame': 'Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period'}, {'measure': 'Change in peak oxygen uptake', 'timeFrame': 'Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period'}, {'measure': 'Change in functional ability', 'timeFrame': 'Baseline, post-revascularization (ET or open intervention), post-12 weeks (exercise and control groups), 6 months following intervention time period', 'description': 'Functional ability will be assessed with the 6-min walk test and Short Physical Performance Battery which consists of 1) walking short distances, 2) completing balance tests and 3) sit and standing from a chair 5 times.'}, {'measure': 'Evaluation of total volume of activity', 'timeFrame': 'post-12 weeks (exercise and control groups)'}, {'measure': 'Evaluation of exercise adherence', 'timeFrame': 'post-12 weeks (exercise and control groups)', 'description': 'For patients randomized to the exercise therapy group'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['claudication', 'community walking exercise', 'community-based participatory research', 'exercise adherence', 'endovascular therapy'], 'conditions': ['Peripheral Artery Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.nhlbi.nih.gov/', 'label': 'Click here for more information about the sponsor.'}, {'url': 'http://www.nih.gov/', 'label': 'Click here for more information about the sponsor.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of the study is to determine the effect of a community-based walking exercise program with detailed training, monitoring, and coaching (TMC) exercise components enhanced by community-based participatory research (CBPR) practices (TMC+) on the primary outcome of peak walking time (PWT) in patients with peripheral artery disease (PAD).', 'detailedDescription': 'The investigators will test the hypothesis that PAD patients randomized to the exercise program in the community setting incorporating TMC+ will improve walking ability compared with patients who receive the standard of care (exercise advice). Secondary hypotheses include a significant improvement in patient-reported outcomes, an improvement in functional ability or a significant increase in volume of physical activity for patients who complete community-based walking exercise when compared with patients receiving the standard of care. Exploratory hypotheses include a significant improvement in PWT for 1) patients receiving a combination of lower extremity endovascular therapy (ET) and community-based walking exercise or 2) open peripheral intervention and community-based walking exercise compared to patients who do not receive endovascular therapy or open intervention and receive only the standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women diagnosed with atherosclerotic PAD\n* ≥40 years of age\n* An abnormal ankle-brachial index (ABI) of ≤.90\n* For patients with an ABI \\>.90 and \\<1.00, a post-exercise ABI drop of 15% or more compared to the resting ABI\n* Patients receiving lower extremity ET or peripheral open intervention\n* Patients not receiving lower extremity ET or peripheral open intervention but present with stable claudication and an abnormal ABI\n\nExclusion Criteria:\n\n* Lower extremity amputation(s), including a toe amputation, which interfere (s) with walking on the treadmill\n* Individuals with critical limb ischemia defined by ischemic rest pain or ischemic ulcers/gangrene on the lower extremities\n* PAD of non-atherosclerotic nature (e.g., fibromuscular dysplasia, irradiation, endofibrosis)\n* Coronary artery bypass grafts or major surgical procedures within 6 months prior to screening\n* Individuals whose walking exercise is primarily limited by symptoms of chronic obstructive pulmonary disease, angina, or heart failure\n* Individuals who are unable to walk on the treadmill at a speed of at least 2 mph for at least 1 minute\n* Individuals who have had a myocardial infarction within 3 months prior to screening\n* Individuals who demonstrate symptoms consistent with acute coronary syndrome\n* Individuals who exhibit ischemia as documented on the 12-lead electrocardiogram including horizontal or down-sloping ST-segment depression ≥0.5 mm at rest and \\>1 mm with exercise in 2 contiguous leads, relative to the PR-segment (ST-segment measured 0.08 seconds after the J point, ST-segment elevation ≥1 mm)\n* Individuals who have had a transient ischemic attack or stroke 3 months prior to screening\n* Individuals with left bundle branch block or sustained ventricular tachycardia (\\>30 sec) during screening\n* Individuals with uncontrolled hypertension (≥180 systolic or ≥100 diastolic resting blood pressure) during screening\n* Treatment with pentoxifylline or cilostazol for the treatment of claudication 4 weeks prior to screening; Patients can be reconsidered for study inclusion following a 1 month washout period from these medications\n* Electrolyte abnormalities (e.g., potassium \\<3.3 mmol∙Lˉ1 )\n* Pregnancy, fertility without protection against pregnancy (for women of childbearing potential, a serum pregnancy test will be performed at screening)\n* Incarcerated individuals\n* Individuals acutely impaired by alcohol or other illicit drugs\n* Poorly controlled diabetes defined as glycated hemoglobin \\>12%\n* Severely anemic patients (Hgb \\<11 g∙dLˉ1 for women and \\<10 g∙dLˉ1 for men)\n* For patients who have not received peripheral revascularization, an ABI of \\>0.90\n* For patients with equivocal resting ABIs (0.91-0.99), a drop of \\<15% in the post-exercise ABI\n* For individuals with non-compressible vessels (ABI \\>1.39) who have a toe- brachial index (TBI) \\>0.70\n* Inability to speak English\n* Other clinically significant disease that is, in the opinion of the study team, not stabilized or may otherwise confound the results of the study'}, 'identificationModule': {'nctId': 'NCT02075502', 'acronym': 'GAIT', 'briefTitle': 'Community Walking Exercise for Patients With Peripheral Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'A Community-based Exercise Program to Improve Walking Outcomes in Patients With Peripheral Artery Disease', 'orgStudyIdInfo': {'id': 'Mays-1'}, 'secondaryIdInfos': [{'id': '1K01HL115534', 'link': 'https://reporter.nih.gov/quickSearch/1K01HL115534', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise therapy', 'description': 'Claudication, no peripheral revasc', 'interventionNames': ['Behavioral: Exercise therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Exercise advice', 'description': 'Claudication, no peripheral revasc', 'interventionNames': ['Behavioral: Exercise therapy']}, {'type': 'EXPERIMENTAL', 'label': 'lower extremity ET, exercise therapy', 'interventionNames': ['Behavioral: Exercise therapy', 'Procedure: lower extremity ET']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'lower extremity ET, exercise advice', 'interventionNames': ['Procedure: lower extremity ET']}, {'type': 'EXPERIMENTAL', 'label': 'Peripheral open intervention, exercise therapy', 'interventionNames': ['Behavioral: Exercise therapy', 'Procedure: peripheral open intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Peripheral open intervention, exercise advice', 'interventionNames': ['Procedure: peripheral open intervention']}], 'interventions': [{'name': 'Exercise therapy', 'type': 'BEHAVIORAL', 'description': "The exercise therapy program with training, monitoring and coaching enhanced by community-based participatory research (CBPR) (TMC+) is a comprehensive approach to community-based walking exercise for improving PAD patient outcomes. The components of TMC+ are optimal training guidelines for patients (i.e., T), monitoring from both investigators and patient self-monitoring (i.e., M), coaching from investigators on how to improve patients' walking ability (i.e., C), and finally enhancements from CBPR practices (+).", 'armGroupLabels': ['Exercise advice', 'Exercise therapy', 'Peripheral open intervention, exercise therapy', 'lower extremity ET, exercise therapy']}, {'name': 'lower extremity ET', 'type': 'PROCEDURE', 'description': 'catheter-based revascularization of peripheral arteries (background treatment part of standard clinical care at hospital)', 'armGroupLabels': ['lower extremity ET, exercise advice', 'lower extremity ET, exercise therapy']}, {'name': 'peripheral open intervention', 'type': 'PROCEDURE', 'description': 'revascularization of lower extremities with open bypass surgery (background treatment part of standard clinical care at hospital)', 'armGroupLabels': ['Peripheral open intervention, exercise advice', 'Peripheral open intervention, exercise therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59802', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'International Heart Institute of Montana Foundation', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}], 'overallOfficials': [{'name': 'Ryan J. Mays, PhD, MPH, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Heart Institute of Montana Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}