[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493994":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":56,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":25,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":25,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"University of Oklahoma","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-Ischemic Exercise (NICE) exercise program","EXPERIMENTAL","Patients will perform supervised treadmill walking for 3 months. Patients randomized to the NICE program will walk intermittently at a slow speed of approximately 1.4 mph for only 2-3 minute bouts that do not elicit claudication pain.",[13],"Behavioral: Exercise",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard exercise program","ACTIVE_COMPARATOR","Patients will perform supervised treadmill walking for 3 months. Patients randomized to the Standard program will walk intermittently at a speed of approximately two mph to near maximal claudication pain.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Exercise","Non-Ischemic Exercise (NICE), pain-free exercise program will be compared to the Standard painful exercise program.",[9,15],null,[27],{"name":28,"affiliation":29,"role":30},"Andrew W. Gardner, Ph.D","Professor, Department of Medicine, Cardiology","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Andrew W. Gardner, Ph.D.","CONTACT","405-271-4742","andrew-gardner@ouhsc.edu",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"O'Donoghue Research Building, University of Oklahoma Health Sciences Center","RECRUITING","Oklahoma City","Oklahoma","73117","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-97.51643,35.46756,{"lat":50,"lon":49},[53],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},{"type":55,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[57,59],{"name":58,"class":6},"Case Western Reserve University",{"name":60,"class":61},"National Institute on Aging (NIA)","NIH","100493994","the-effects-of-a-novel-non-ischemic-and-pain-free-exercise-intervention-in-peripheral-artery-disease-100493994",false,"NCT05712395","The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease","NICE","Inclusion Criteria:\n\n1. history of claudication assessed by the Walking Impairment Questionnaire,\n2. ambulatory leg pain in either one or both legs consistent with intermittent claudication confirmed during a screening graded treadmill test using the Gardner-Skinner protocol,\n3. an ABI \\\u003C= 0.90 at rest or \\> 20% decrease in ankle systolic blood pressure in either one or both legs immediately following the treadmill exercise test.\n4. age \\>= 40 years.\n\nExclusion Criteria:\n\n1. absence of PAD (ABI \\> 0.90 at rest and ankle systolic blood pressure \\\u003C 20% decrease after exercise,\n2. inability to obtain an ABI measure due to non-compressible vessels (ABI \\> 1.40),\n3. asymptomatic PAD (Fontaine Stage I) determined from the medical history and verified during the graded treadmill test,\n4. rest pain due to PAD (Fontaine stage III)\n5. tissue loss due to PAD (Fontaine stage IV)\n6. use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation,\n7. peripheral revascularization within one month prior to investigation, or peripheral revascularization performed during the study,\n8. exercise tolerance limited by any disease process other than PAD,\n9. active cancer,\n10. kidney failure defined as stage 5 chronic kidney disease,\n11. a calf skin fold measurement \\> 25 mm, because of potential interference with the light path of the NIRS probe from penetrating the subcutaneous tissue,\n12. pulse arterial oxygen saturation of the index finger \\\u003C 95% because of potential deleterious effect on calf muscle StO2 from poor pulmonary gas exchange, and\n13. failure to complete the baseline run-in phase within three weeks.","ALL","40 Years",{"count":72,"type":73},100,"ESTIMATED","INTERVENTIONAL",[76],"NA","This study is a 3-month, prospective, randomized controlled clinical trial designed to address the efficacy of the Non-Ischemic Exercise (NICE) program to improve exercise and vascular outcome measures in patients with peripheral artery disease (PAD).",[79,80],"Claudication","Peripheral Artery Disease","2026-05-26",{"date":83,"type":84},"2026-05-29","ACTUAL",{"date":86,"type":84},"2024-09-09",{"date":88,"type":73},"2029-07-31",{"name":5,"class":6},1]