[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559656":3},{"organization":4,"outcomesModule":7,"designInfo":114,"detailedDescription":121,"studyPopulation":117,"armGroups":122,"interventions":139,"overallOfficials":117,"centralContacts":150,"locations":161,"responsibleParty":188,"collaborators":191,"id":194,"slug":117,"hasResults":195,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":195,"sex":201,"minAge":202,"maxAge":117,"enrollmentInfo":203,"targetDuration":117,"studyType":206,"phases":207,"briefSummary":209,"conditions":210,"keywords":117,"overallStatus":164,"whyStopped":117,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":221},{"fullName":5,"class":6},"Palo Alto Veterans Institute for Research","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":104},[9],{"measure":10,"description":11,"timeFrame":12},"Time to claudication pain","Time to initial onset of claudication pain with exercise treadmill test.","Baseline, 6 weeks, 14 weeks, 22 weeks",[14,17,20,23,26,30,33,36,39,42,45,48,51,54,57,60,63,66,69,72,75,78,81,84,87,90,92,95,98,101],{"measure":15,"description":16,"timeFrame":12},"Peak VO2","Peak V02 will be determined on a treadmill using an individualized ramp protocol with collection of continuous ventilatory gas exchange responses.",{"measure":18,"description":19,"timeFrame":12},"6-minute walk test (6MWT)","Total distance (meters) of walk in 6 minutes.",{"measure":21,"description":22,"timeFrame":12},"Walking Impairment Questionnaire (WIQ)","Developed to evaluate walking limitations in patients with PAD. Assesses the ability of individuals to walk defined distances and speeds and climb stairs.",{"measure":24,"description":25,"timeFrame":12},"Peripheral Artery Questionnaire (PAQ)","20-item questionnaire developed and validated specifically for PAD and is designed to quantify patients' physical limitations, symptoms, social function, treatment satisfaction, and quality of life.",{"measure":27,"description":28,"timeFrame":29},"Walking","Physical activity patterns, expressed as steps\u002Fday will be quantified using fitness\u002Fhealth tracking device.","Up to 22 weeks",{"measure":31,"description":32,"timeFrame":29},"Energy expenditure","Energy expenditure will be quantified using fitness\u002Fhealth tracking device.",{"measure":34,"description":35,"timeFrame":12},"Chair raises","Number of repetitions completed within 60 seconds (46cm high seat).",{"measure":37,"description":38,"timeFrame":12},"Upper body strength","1 repetition max for Chest Press.",{"measure":40,"description":41,"timeFrame":12},"Lower body strength","1 repetition max for Leg Extension.",{"measure":43,"description":44,"timeFrame":12},"Hand grip strength","Maximum isometric strength will be measured using a hand grip dynamometer.",{"measure":46,"description":47,"timeFrame":12},"Insulin sensitivity","Fasting glucose and insulin samples will be obtained from blood draw to generate Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) score.",{"measure":49,"description":50,"timeFrame":12},"Lipid panel","Fasting total cholesterol, LDL, HDL and triglycerides will be assessed from blood draw.",{"measure":52,"description":53,"timeFrame":12},"Sodium","Standard Chem 20 blood draw will be used to obtain sodium in blood value.",{"measure":55,"description":56,"timeFrame":12},"Homocysteine","Homocysteine will be assessed from blood draw.",{"measure":58,"description":59,"timeFrame":12},"High-sensitivity C-reactive protein (hs-CRP)","High-sensitivity C-reactive protein (hs-CRP) will be assessed from blood draw.",{"measure":61,"description":62,"timeFrame":12},"Interleukin-6 (IL-6)","Interleukin-6 (IL-6) will be assessed from blood draw.",{"measure":64,"description":65,"timeFrame":12},"D-dimer","D-dimer will be assessed from blood draw.",{"measure":67,"description":68,"timeFrame":12},"Blood protein","Blood draw will be used to obtain blood protein value.",{"measure":70,"description":71,"timeFrame":12},"Albumin","Blood draw will be used to obtain albumin in blood value.",{"measure":73,"description":74,"timeFrame":12},"Calcium","Blood draw will be used to obtain calcium in blood value.",{"measure":76,"description":77,"timeFrame":12},"Potassium","Blood draw will be used to obtain potassium in blood value.",{"measure":79,"description":80,"timeFrame":12},"Chloride","Blood draw will be used to obtain chloride in blood value.",{"measure":82,"description":83,"timeFrame":12},"Carbon dioxide","Blood draw will be used to obtain carbon dioxide in blood value.",{"measure":85,"description":86,"timeFrame":12},"AST\u002FGOTU\u002Fl","Blood draw will be used to obtain AST\u002FGOTU\u002Fl in blood value.",{"measure":88,"description":89,"timeFrame":12},"ALT\u002FGPT","Blood draw will be used to obtain ALT\u002FGPT in blood value.",{"measure":91,"description":89,"timeFrame":12},"ALK Phosphatase",{"measure":93,"description":94,"timeFrame":12},"Bilirubin","Blood draw will be used to obtain total bilirubin in blood value.",{"measure":96,"description":97,"timeFrame":12},"Urea Nitrogen","Blood draw will be used to obtain urea nitrogen in blood value.",{"measure":99,"description":100,"timeFrame":12},"Creatinine","Blood draw will be used to obtain creatinine in blood value.",{"measure":102,"description":103,"timeFrame":12},"eGFR","Blood draw will be used to obtain eGFR value.",[105,108,111],{"measure":106,"description":107,"timeFrame":12},"Endothelial function","The Endo Pat 2000 system will be used to perform this procedure. Both forearms will be occluded with a standard blood pressure cuff for 5 minutes.",{"measure":109,"description":110,"timeFrame":12},"Ankle-brachial index (ABI)","Using a standard brachial artery cuff method with a Doppler ultrasound probe at the posterior tibial artery to determine ABI.",{"measure":112,"description":113,"timeFrame":12},"Exercise Benefits and Barriers Scale (EBBS)","Perceived barriers and benefits to physical activity will be assessed using two methods: a semi-structured interview and administration of the Exercise Benefits and Barriers Scale (EBBS), to obtain both open-ended qualitative and quantitative data on these constructs. The EBBS may be used in its entirety or as two seperate scales. As a whole, scoring for EBBS ranges from 43 to 172 with a higher score being the individual perceives exercise more positively. When the Benefits Scale is used alone, the score range is between 29 to 116 with the higher the score being the individual perceives exercise more positively. When the Barriers Scale is used alone, the score range is between 14 to 56. The higher the score on the Barriers Scale, the greater the perception of barriers to exercise.",{"allocation":115,"interventionModel":116,"interventionModelDescription":117,"primaryPurpose":118,"observationalModel":117,"timePerspective":117,"maskingInfo":119},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":120,"maskingDescription":117,"whoMasked":117},"NONE","Peripheral artery disease (PAD) is a form of cardiovascular disease that affects the arteries supplying blood flow to the legs. The prevalence of PAD is increasing rapidly in the United States. When PAD is severe, it can cause pain with movement and limit a person's ability to walk or perform their normal daily activities. With severe PAD, a procedure is often performed in which an artery is held open with a small tube called a stent.\n\nPrograms of exercise-based rehabilitation have been shown to greatly help these patients in terms of the pain they experience with walking, their ability to perform daily activities or those required by work, and improved quality of life. There is also a newer form of therapy, called prehabilitation, which has been shown to have important benefits for patients with PAD. Prehabilitation involves four to six weeks of exercise therapy and lifestyle recommendations before undergoing a stent procedure. Prehabilitation helps patients improve exercise tolerance and make lifestyle changes that improve risk factors before the procedure. Those who participate in prehabilitation programs have fewer complications with the stent procedure, spend fewer days in the hospital, and have a better ability to exercise and return to work more quickly.\n\nAlthough the benefits of prehabilitation and rehabilitation are well established, most doctors neglect to recommend these treatments to their patients who undergo a stent procedure for PAD. The research team will study the impact of prehabilitation, rehabilitation or both forms of therapy. The results will likely encourage more doctors to recommend the best option for their patients, and possibly to recommend both prehabilitation and rehabilitation among patients who are having a stent procedure.",[123,130,135],{"label":124,"type":125,"description":126,"interventionNames":127},"Prehabilitation","EXPERIMENTAL","Subjects randomized to the prehabilitation group will undergo 6 weeks of individualized exercise therapy, including a 1-week ramp-up period (3 sessions) conducted at the VAPAHCS rehabilitation facility. Subjects will then exercise primarily at home, with an in-clinic exercise session repeated weekly for the duration of their participation. These sessions will be individualized based on tolerance and in accordance with standardized guidelines, but will generally consist of 45-60 min of supervised exercise that combines aerobic and resistance training, including warm-up and cool-down. Throughout the study, subjects will be asked to perform 30 minutes of daily unsupervised aerobic exercise of their choice, with an emphasis on improving walking performance at home. Guidelines for patient monitoring, safety, and prescription outlined by the American Heart Association, American College Sports Medicine, and American Association of Cardiovascular and Pulmonary Rehabilitation will be followed.",[128,129],"Other: Exercise Intervention","Other: VAPAHCS Rehabilitation Core Components",{"label":131,"type":132,"description":133,"interventionNames":134},"Rehabilitation","ACTIVE_COMPARATOR","Subjects randomized to the rehabilitation group will initiate exercise sessions approximately 2-weeks following endovascular intervention as outlined in guidelines for PAD. Patient stability and wound patency will be paramount considerations prior to a patient beginning the rehabilitation program. Similar to prehabilitation, subjects will undergo a 1-week, 3 session familiarization period conducted at the VAPAHCS rehabilitation facility, then return once weekly for in-clinic supervised sessions. The weekly in-person visits will be conducted at the rehabilitation center to monitor and encourage compliance, review activity questionnaires, download accelerometry data, and address any clinical concerns. Similar to participants in the prehabilitation group, the 6-week rehabilitation period will be individualized and follow standardized guidelines designed for rehabilitation in patients with PAD.",[128,129],{"label":136,"type":125,"description":137,"interventionNames":138},"Prehabiliation and Rehabilitation","Subjects randomized to the prehabilitation and rehabilitation group will undergo both the 6 weeks of prehabilitation pre-operative and 6 weeks of rehabilitation post-operative as described in their respective arm descriptions.",[128,129],[140,146],{"type":6,"name":141,"description":142,"armGroupLabels":143,"otherNames":144},"Exercise Intervention","Aerobic and resistance exercise will be components of the prehabiliation and rehabilitation programs. Given the presence of PAD, a particular emphasis will be placed on volume of walking and improving walking performance.",[136,124,131],[145],"Exercise Therapy",{"type":6,"name":147,"description":148,"armGroupLabels":149,"otherNames":117},"VAPAHCS Rehabilitation Core Components","The prehabilitation and rehabilitation programs include all Core Components of rehabilitation as outlined in guidelines. The current clinical VAPAHCS program includes smoking cessation, nutrition, risk factor management and psychosocial counseling referrals as appropriate, and these services will be available for the current proposal.",[136,124,131],[151,157],{"name":152,"role":153,"phone":154,"phoneExt":155,"email":156},"Jonathan N Myers, PhD","CONTACT","650-493-5000","64661","drj993@aol.com",{"name":158,"role":153,"phone":159,"phoneExt":117,"email":160},"Charles G Gronau, DCEP","618-746-69565","gronauc92@gmail.com",[162],{"facility":163,"status":164,"city":165,"state":166,"zip":167,"country":168,"countryCode":169,"cosmosGeoPoint":170,"geoPoint":175,"contacts":176},"VA Palo Alto Health Care System","RECRUITING","Palo Alto","California","94304","United States","US",{"type":171,"coordinates":172},"Point",[173,174],-122.14302,37.44188,{"lat":174,"lon":173},[177,178,180,182,184,186],{"name":152,"role":153,"phone":154,"phoneExt":155,"email":156},{"name":158,"role":153,"phone":179,"phoneExt":117,"email":160},"618-746-6956",{"name":152,"role":181,"phone":117,"phoneExt":117,"email":117},"PRINCIPAL_INVESTIGATOR",{"name":158,"role":183,"phone":117,"phoneExt":117,"email":117},"SUB_INVESTIGATOR",{"name":185,"role":183,"phone":117,"phoneExt":117,"email":117},"Khin N Chan, MD",{"name":187,"role":183,"phone":117,"phoneExt":117,"email":117},"Pallavi Gautam, MPT",{"type":181,"investigatorFullName":189,"investigatorTitle":190,"investigatorAffiliation":5,"oldNameTitle":117,"oldOrganization":117},"Jonathan Myers","Principal Investigator",[192],{"name":193,"class":6},"Patient-Centered Outcomes Research Institute","100559656",false,"NCT06566976","Prehabilitation and Rehabilitation in PAD","Prehabilitation and Rehabilitation in PAD: A Randomized Exercise Intervention Trial (PREPARE-IT)","PREPARE-IT","Inclusion Criteria:\n\n* Male or Female adult diagnosed with peripheral artery disease (PAD)\n* Experiencing leg pain while walking\n* Scheduled to have a stent for PAD\n* Able to perform exercise safely\n* Postmenopausal and not of child bearing capacity\n\nExclusion Criteria:\n\n* Medically unstable patients\n* Recent MI within 3 months\n* Malignancy\n* Uncontrolled diabetes mellitus (HBA1C ≥8 mmol\u002Fl)\n* Alcoholism or other recreational drug use","ALL","18 Years",{"count":204,"type":205},300,"ESTIMATED","INTERVENTIONAL",[208],"NA","To determine the effectiveness of pre and post-operative exercise therapy in patients undergoing peripheral artery stenting for peripheral arterial disease.",[211],"Peripheral Arterial Disease","2024-08-19",{"date":214,"type":215},"2024-08-22","ACTUAL",{"date":217,"type":215},"2024-03-07",{"date":219,"type":205},"2027-07-25",{"name":5,"class":6},1]