[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100432757":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":44,"responsibleParty":63,"collaborators":25,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":25,"maxAge":25,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Ottawa Heart Institute Research Corporation","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Strict Arm","ACTIVE_COMPARATOR","The strict arm group will be given the following restrictions. These restrictions are the current institutional protocol at the study site and falls within common practice pattern across Canada:\n\n1. No arm or shoulder movement x 24 hours\n2. No movement of affected arm overhead x 8 weeks\n3. No lifting anything heavier than 5 lbs (2.5kg) and avoid any kind of sports or other vigorous activities including golf, tennis, swimming or sweeping x 8 weeks\n4. Avoid any kind of shovelling x 8 weeks",[13],"Behavioral: Strict Arm Restriction",{"label":15,"type":10,"description":16,"interventionNames":17},"Lenient Arm","The lenient arm restriction group will be given the following restrictions. The justification for the selected lenient restriction is based on the current recommendations at a Canadian center as identified by the national survey:\n\n1. No shoveling 7 days,\n2. No golfing\u002Fswimming\u002Ftennis 14 days\n3. No other restrictions (overhead activity and weight lifting no limitation)",[18],"Behavioral: Lenient Arm Restriction",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Lenient Arm Restriction","The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.",[15],null,{"type":21,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"Strict Arm Restriction",[9],[30],{"name":31,"affiliation":5,"role":32},"David Birnie","PRINCIPAL_INVESTIGATOR",[34,40],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Tammy Knight","CONTACT","613.696.7000","19080","tknight@ottawaheart.ca",{"name":41,"role":36,"phone":42,"phoneExt":25,"email":43},"Mehrdad Golian","613.696.7271","mgolian@ottawaheart.ca",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"University of Ottawa Heart Institute","RECRUITING","Ottawa","Ontario","K1Y 4W7","Canada","CA",{"type":54,"coordinates":55},"Point",[56,57],-75.69812,45.41117,{"lat":57,"lon":56},[60,62],{"name":35,"role":36,"phone":61,"phoneExt":38,"email":39},"6136967000",{"name":41,"role":36,"phone":61,"phoneExt":25,"email":43},{"type":32,"investigatorFullName":31,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Deputy Chief, Division of Cardiology, University of Ottawa Heart Institute","100432757","phase-4-a-randomized-trial-of-lenient-versus-strict-arm-instruction-post-cardiac-device-surgery-100432757",false,"NCT04915261","A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery","A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery - LENIENT","LENIENT","Inclusion Criteria:\n\n* all patients undergoing device surgery which includes implantation of at least one new endovascular lead\n\nExclusion Criteria:\n\n* Standalone CIED generator replacement\n* Subcutaneous implantable cardioverter defibrillators\n* Leadless endocardial pacemakers\n* Temporary permanent pacemakers",true,"ALL",{"count":76,"type":77},6300,"ESTIMATED","INTERVENTIONAL",[80],"PHASE4","The purpose and objectives of this study is to investigate whether reducing the existing arm restrictions on patients who receive Cardiac Implantable Electronic Devices (CIED) will result in an improved patient experience post operatively and reduce complication rates. There are multiple and varied arm restriction instructions given to patients receiving CIED's with limited universally accepted protocols or advice on restrictions for patients following surgery.\n\nRestrictions such as arm immobilization, showering and weight lifting, in addition to contradictory advice between various hospitals and physicians, can negatively affect patient quality of life and increase patient anxiety with no current evidence for benefit. A cluster cross over randomized trial has been designed to test the comparative effectiveness of lenient vs strict arm restrictions for all patients receiving implantable devices.\n\nInstructions within both arms of this study are considered within reasonable practice in Canada.\n\nAll arm restriction instructions and parameters will be embedded within EPIC, nurses will teach the restriction in addition they will be provide to the patients via printed EPIC discharge summaries. Further links will be embedded in the After Visit Summary (AFS) printouts and my Chart for patients in EPIC. These instructions will be changed every 8 months, as per the crossover design of the trial. Additionally, both arms will utilize interactive voice recognition (IVR) to provide patients with further reminders and instruction on arm restrictions.\n\nAll patients are given standard of care instructions for follow up and complication assessment through the investigators' device clinic and 24\u002F7 on call nursing program.",[83],"Post-Op Complication",[85,86,87,88,89,90,91,92,93,94,95],"Cardiac","Implantable","Electronic","Device","Arm","Restriction","Post-operative","infection","dislodgement","hematoma","DVT","2025-12-05",{"date":98,"type":99},"2025-12-15","ACTUAL",{"date":101,"type":99},"2021-08-19",{"date":103,"type":77},"2030-08-01",{"name":5,"class":6},1]