[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100430747":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":39,"centralContacts":44,"locations":50,"responsibleParty":67,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":31,"enrollmentInfo":83,"targetDuration":31,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":52,"whyStopped":31,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Performance evaluation","OTHER","Preliminary performance evaluation to refine the Smart MOVE! intervention.",[13],"Behavioral: Performance evaluation",{"label":15,"type":16,"description":17,"interventionNames":18},"Smart MOVE!","ACTIVE_COMPARATOR","Participants will be enrolled in the multi-component Smart MOVE! intervention for 12 weeks.",[19],"Behavioral: Smart MOVE!",{"label":21,"type":22,"description":23,"interventionNames":24},"Usual care","PLACEBO_COMPARATOR","Participants will receive general walking advice for 12 weeks.",[25],"Behavioral: General walking advice",[27,32,36],{"type":28,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"BEHAVIORAL","Multi-component behavioral intervention of PAD consisting of:\n\n1. guideline-directed HBET prescription\n2. active behavioral coaching (via MOVE! program or other)\n3. mobile health monitoring",[15],null,{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"General walking advice","Basic guidance on performing walking exercises for PAD according to established guidelines. Participants will receive a mobile health device for self-tracking only but not receive any behavioral coaching.",[21],{"type":28,"name":9,"description":37,"armGroupLabels":38,"otherNames":31},"Preliminary performance evaluation determine the optimal components of the Smart MOVE! intervention. Specific procedures will include:\n\n1. Provider and stakeholder interviews\n2. PAD patient interviews\n\n2\\) N-of-1 trials to refine the intervention",[9],[40],{"name":41,"affiliation":42,"role":43},"Arash Harzand, MD","Atlanta VA Medical and Rehab Center, Decatur, GA","PRINCIPAL_INVESTIGATOR",[45],{"name":41,"role":46,"phone":47,"phoneExt":48,"email":49},"CONTACT","(404) 321-6111","20-5523","Arash.Harzand@va.gov",[51],{"facility":42,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Decatur","Georgia","30033-4004","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-84.29631,33.77483,{"lat":62,"lon":61},[65,66],{"name":41,"role":46,"phone":47,"phoneExt":48,"email":49},{"name":41,"role":43,"phone":31,"phoneExt":31,"email":31},{"type":68,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[70],{"name":71,"class":72},"LifeQ","UNKNOWN","100430747","exercise-therapy-for-pad-using-mobile-health-100430747",false,"NCT04889105","Exercise Therapy for PAD Using Mobile Health","Enhanced Home-Based Exercise Therapy for Peripheral Arterial Disease Through Mobile Health and Remote Monitoring","Smart MOVE","Inclusion Criteria:\n\n* Age \\>40 years\n* Eligible Veteran status\n* Clinically stable intermittent claudication ( 2 months of Rutherford Class II symptoms, no evidence of chronic limb-threatening ischemia)\n* Established PAD diagnosis (abnormal ankle-brachial index or evidence of PAD on prior certified vascular laboratory or radiology imaging)\n* Access to safe location to perform walking exercises\n\nExclusion Criteria:\n\n* Above or below knee amputation\n\n  * critical limb ischemia (rest pain or tissue loss including ulceration or gangrene)\n  * inability to walk without a walker\n  * wheelchair confinement\n  * non-English speaking\n  * significant visual impairment that interferes with walking activity\n  * hearing impairment that interferes with full study participation\n  * unable or unwilling to return to the medical center at the expected visit frequency or unable or unwilling to use the technology required for the intervention\n* Individuals whose walking is limited by a condition other than PAD\n* Any active cardiac condition including unstable angina\n\n  * unstable atrial or ventricular arrhythmias\n  * high-grade heart block without a pacemaker\n  * active myopericarditis\n  * recent venous thromboembolism\n  * or recent abnormal baseline stress test suggesting ischemia\n  * other high-risk findings (e.g., drop of systolic blood \\> 20 mmHg with exercise)\n* Presence of Class III NYHA heart failure or CCS III angina.\n* Major surgery including lower extremity revascularization or orthopedic surgery during the preceding three months or anticipated in the next nine months\n* Major medical illness including lung disease requiring continuous oxygen (patients wearing nighttime oxygen only may still qualify)\n\n  * neurodegenerative disorders such as Parkinson's Disease that impair walking ability\n  * cancer requiring treatment in the past 2 years (with exception for non-melanoma skin cancer or if they received treatment for early-stage cancer with an excellent overall prognosis)\n* Heart attack, stroke, or coronary artery bypass surgery in the preceding 3 months\n* Mental health illness that may interfere with the ability to consent and\u002For participate in the study, including mini-mental status examination score \\\u003C24\n\n  * dementia\n  * active psychiatric disorder such as schizophrenia or bipolar disorder\n  * history of suicidal or homicidal ideation in the preceding six months\n  * history of suicidal attempts in the preceding 12 months\n  * history of active substance use in the preceding six months that would interfere with study participation (as determined by their primary care or mental health provider)\n* Subjects endorsing SI or HI may be eligible for continued participation with monitoring if approved by their primary mental health provider\n* Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention\n* Currently enrolled in another clinical trial or structured exercise program (i.e., cardiac rehabilitation)\n* Deemed to be poorly suited for the study or the study intervention at the discretion of the PI or study staff","ALL","40 Years",{"count":84,"type":85},75,"ESTIMATED","INTERVENTIONAL",[88],"NA","Peripheral artery disease (PAD) is a highly prevalent condition affecting up to 10% of Veterans that leads to loss of walking ability and increased risk of amputation. Veterans have limited access to supervised exercise therapy, a facility-based program proven to improve walking ability in PAD, which is poorly attended due to the inconvenience and cost of attending a 12-week program with multiple weekly sessions. This CDA-2 application will investigate the feasibility of home-based exercise therapy (HBET) delivered using mobile health (mHealth) technologies in Veterans with symptomatic PAD. We will partner with the MOVE! program to deliver HBET through group behavioral coaching and a novel wearable activity monitor in a newly proposed program called Smart MOVE!. There is a clear need to provide effective and convenient alternatives to supervised exercise for Veterans with PAD. This study will provide evidence to proceed with Smart MOVE!, a much-needed patient-centered rehabilitation program for Veterans with PAD.",[91],"Peripheral Artery Disease",[93,94,95],"Mobile health","Telemedicine","Peripheral artery disease","2026-04-15",{"date":98,"type":99},"2026-04-21","ACTUAL",{"date":101,"type":99},"2021-12-01",{"date":103,"type":85},"2026-09-30",{"name":5,"class":6},1]