[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516387":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":65,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":25,"maxAge":25,"enrollmentInfo":80,"targetDuration":25,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Oxygen guided supervised exercise","EXPERIMENTAL","Modified-SET parameters will be determined from resting StO2 during 10 minutes of sitting. The StO2 threshold will be set at 15% lower than baseline StO2 levels. After warm-up, the subjects will walk until they reach the StO2 threshold. The subjects will be instructed to stop walking once they reach the threshold and to rest until the StO2 level returns to the baseline level. Then, subjects will be instructed to begin walking again and this cycle will be repeated for 50 total minutes. The threshold was selected to be above the 31% drop associated with claudication onset time. If subjects experience pain earlier than the 15% drop, the threshold will be progressively decreased by 5%, as needed. Subjects will repeat this for up to 50 minutes (including walking and rest). Walking speed and treadmill incline will be adjusted to allow for 5-10 minutes of walking before reaching the threshold. Subjects will complete 3 sessions\u002Fweek for 12 weeks.",[13],"Behavioral: Supervised exercise therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard supervised exercise","ACTIVE_COMPARATOR","After the warmup, subjects will walk until claudication pain becomes severe and needs to stop. Then subjects will rest until claudication pain subsides. Afterwards, subjects will walk again, repeating the cycle for up to 50 minutes (including walking and rest). Walking speed and treadmill incline will be adjusted during the SET session to allow individuals with PAD to walk for 5-10 minutes before claudication symptoms arise. Time at each speed and incline, along with rest times will be recorded during each exercise session. Subjects will complete 3 sessions\u002Fweek for 12 weeks.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Supervised exercise therapy","Subjects will be enrolled in a 12-week intervention program of either modified supervised exercise therapy or standard supervised exercise therapy. The program will be 3 sessions\u002Fweek for 12 weeks. Each session will consist of 50 minutes plus 5 minutes warm up and cool down.",[9,15],null,[27],{"name":28,"affiliation":29,"role":30},"Iraklis I Pipinos, MD","Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Farahnaz Fallahtafti, PhD","CONTACT","(402) 995-3542","ffallahtafti@unomaha.edu",{"name":38,"role":34,"phone":39,"phoneExt":25,"email":40},"Sara A Myers, PhD","(402) 554-3246","Sara.Myers2@va.gov",[42],{"facility":29,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Omaha","Nebraska","68105-1850","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-95.94043,41.25626,{"lat":53,"lon":52},[56,60,64],{"name":57,"role":34,"phone":58,"phoneExt":25,"email":59},"Frederick G Hamel, PhD","402-995-3540","Frederick.Hamel@va.gov",{"name":61,"role":34,"phone":62,"phoneExt":25,"email":63},"Amy M Patten","(402) 995-3541","amy.patten@va.gov",{"name":28,"role":30,"phone":25,"phoneExt":25,"email":25},{"type":66,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[68],{"name":69,"class":70},"University of Nebraska","OTHER","100516387","oxygen-guided-supervised-exercise-therapy-100516387",false,"NCT06003855","Oxygen-guided Supervised Exercise Therapy","Oxygen-guided Supervised Exercise Therapy in Peripheral Artery Disease","MOMET","Inclusion Criteria:\n\nAt entry into the study, all subjects must:\n\n* Be able to give written, informed consent\n* Have documented lower extremity arterial occlusive disease based on ankle\u002Fbrachial index measurements and\u002For arterial imaging\n* Demonstrate positive history of chronic claudication\n* Have a stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks\n\nExclusion Criteria:\n\nAny potential subjects will be excluded if they have:\n\n* Rest pain or tissue loss due to PAD (Fontaine stage III and IV)\n* Acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma\n* Walking capacity limited by conditions other than claudication including leg (joint\u002Fmusculoskeletal, neurologic) and systemic (heart, lung disease) pathology","ALL",{"count":81,"type":82},12,"ESTIMATED","INTERVENTIONAL",[85],"NA","Peripheral artery disease (PAD) is a cardiovascular disease manifesting from systemic atherosclerosis, which blocks the leg arteries and results in insufficient blood flow to the lower extremities. Limb ischemia from PAD is the most common disorder treated within the vascular surgery service at the Omaha Veterans' Affairs Medical Center. PAD also accounts for one-third of the operations performed in the VA Medical Centers nationwide. This project aims to establish the feasibility and acceptability of a muscle oxygen-guided supervised exercise program for patients with PAD. The investigators will determine the potential benefits of using this intervention over standard supervised exercise therapy. This modified intervention may enable patients to increase overall physical activity without the negative impacts on muscle structure and function. Increasing physical activity will decrease cardiovascular morbidity and mortality. If proven beneficial, the findings will lead to an improved exercise program that directly benefits veterans nationwide.",[88],"Peripheral Artery Disease",[90,91,92,93],"peripheral arterial disease","atherosclerosis","arterial occlusive disease","gait","2026-01-09",{"date":96,"type":97},"2026-01-13","ACTUAL",{"date":99,"type":97},"2023-10-01",{"date":101,"type":82},"2026-12-30",{"name":5,"class":6},1]