[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510376":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":83,"collaborators":85,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":41,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":41,"overallStatus":49,"whyStopped":41,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Baystate Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"RPE (usual care)","ACTIVE_COMPARATOR","Participants randomized to usual care (RPE) will not complete a GXT. They will instead be scheduled for an approximately 5-minute educational session (i.e., time\u002Fattention-matched control condition) where they will receive information about heart-healthy nutrition. This is standard care at both sites. Patients in the control group will follow standard exercise prescription protocols in CR. This will include a baseline exercise assessment on exercise equipment in the gym (e.g., treadmill, elliptical, rower, NuStep, and\u002For stationary bicycle) as appropriate. Based on exercise levels achieved on the first day, patients will be given exercise recommendations for their 2nd session of CR and so forth. Participants will be asked to exercise at a moderate intensity RPE level at both sites. As the patients progress in CR, patients will increase their time, intensity, and mode of exercise guided by RPE and clinical assessment.",[13],"Behavioral: RPE (usual care)",{"label":15,"type":16,"description":17,"interventionNames":18},"GXT+ THHR (intervention)","EXPERIMENTAL","Patients assigned to the intervention group will complete a GXT approximately one week later and ideally prior to the 4th cardiac rehabilitation session. Resting and peak heart rate from the GXT will be recorded and used to calculate a target heart rate range (THRR) using the Karvonen formula (60-85% Heart rate reserve). After the test, they will receive psychoeducational feedback (PF) about their test results and exercise performance. After the PF, we will discuss the THRR and how it will be used to guide exercise intensity in CR. Patients in the intervention group will use their THHR to adjust their exercise intensity. For the first 6 cardiac rehabilitation sessions, patients will receive feedback about heart rate from the PolarHR monitor, research staff and CR staff when available. The goal is for patients to exercise in THRR for the majority of each exercise session.",[19],"Behavioral: GXT+THHR (intervention)",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Patients in the active comparator group will follow standard exercise prescription protocols in cardiac rehabilitation.",[9],[26],"Relative Perceived Exertion (RPE) Exercise Group",{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"GXT+THHR (intervention)","Patients in the personalized care group will perform a graded exercise test and the peak heart rate from the test will allow the researcher to calculate a target heart rate range (THRR). Then, the patients will receive psychoeducational feedback (PF) about their test results and exercise performance. After PF, their THRR will be reviewed and how it will be used to guide exercise intensity in CR will be discussed.",[15],[32],"Experimental: Graded Exercise Test (GXT) + Target Heart Rate Range (THHR)",[34],{"name":35,"affiliation":5,"role":36},"Quinn R Pack, MD","PRINCIPAL_INVESTIGATOR",[38,43],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","413-794-5856",null,"quinn.pack@baystatehealth.org",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},"Karen L Riska, PhD","413-794-0303","karen.riska@baystatehealth.org",[48,66],{"facility":5,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Springfield","Massachusetts","01199","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-72.58981,42.10148,{"lat":59,"lon":58},[62,64],{"name":63,"role":39,"phone":41,"phoneExt":41,"email":42},"Quinn Pack, MD",{"name":65,"role":39,"phone":41,"phoneExt":41,"email":46},"Karen Riska, PhD",{"facility":67,"status":49,"city":68,"state":69,"zip":70,"country":53,"countryCode":54,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Henry Ford Health System","Detroit","Michigan","48202",{"type":56,"coordinates":72},[73,74],-83.04575,42.33143,{"lat":74,"lon":73},[77,80],{"name":78,"role":39,"phone":41,"phoneExt":41,"email":79},"Clinton Brawner, PhD","cbrawne1@hfhs.org",{"name":81,"role":39,"phone":41,"phoneExt":41,"email":82},"Wanda Qualters","wqualte1@hfhs.org",{"type":84,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[86,88,90,92],{"name":87,"class":6},"Henry Ford Hospital",{"name":89,"class":6},"University of Pennsylvania",{"name":91,"class":6},"Rutgers, The State University of New Jersey",{"name":93,"class":6},"Springfield College","100510376","phase-2-improving-cardiac-rehabilitation-exercise-using-target-heart-rate-trial-100510376",false,"NCT05925634","Improving Cardiac Rehabilitation Exercise Using Target Heart Rate Trial","Improving Outcomes From Cardiac Rehabilitation Among Older Adults Through Exercise Testing and Individualized Exercise Intensity Prescriptions","PACE SETTER","Inclusion Criteria:\n\n* Patients who are eligible for cardiac rehabilitation by having had a cardiac event such as a myocardial infarction (heart attack), heart failure, percutaneous coronary intervention or angioplasty with stent, coronary artery bypass graft, or heart valve surgery in the past 6 months.\n* Lives in, or plans to reside in, the Springfield, MA, or greater Detroit, MI, area for the next year.\n* Recruited from a Phase 2 Cardiac Rehabilitation Center at either Baystate Medical Center or Henry Ford Health System.\n* Age ≥ 60 years\n* Agrees to attend at least 18 sessions of cardiac rehabilitation after randomization\n* Agrees to attend cardiac rehabilitation at least twice a week\n\nExclusion Criteria: These include conditions that alter the physiology and monitoring of resting and exercise heart rate. These also include conditions that might limit an individual's ability to exercise.\n\n* Permanent atrial fibrillation\n* Heart transplant\n* Left-ventricular assist devices\n* Stable angina\n* High-risk un-revascularized coronary artery disease\n* Symptomatic peripheral artery disease\n* Aortic and\u002For mitral stenosis\n* Any condition where exercise testing or training might be unsafe or limited","ALL","60 Years","99 Years",{"count":106,"type":107},320,"ESTIMATED","INTERVENTIONAL",[110],"PHASE2","The goal of this clinical trial is to compare two types of exercise prescriptions in cardiac rehabilitation eligible older adults (60 years or older) with heart disease. The investigators found in a single site pilot trial (insert NCTxxx) that one exercise prescription was better and are now repeating this study in a larger population at two sites (Baystate Medical Center, Springfield MA and Henry Ford Health System, Detroit MI). The main questions the investigators aim to answer are:\n\n1. Compare two different exercise prescriptions in cardiac rehabilitation on exercise outcomes\n\n   1. Graded exercise test +Target heart rate range prescription \\[GXT-THRR\\]\n   2. Rating of perceived exertion (RPE)\n2. What is the role of psychological feedback on fitness outcomes during cardiac rehabilitation and physical activity outside of cardiac rehabilitation.\n3. What are the long-term clinical outcomes between the two exercise prescriptions\n\nParticipants will be asked to:\n\n* Complete surveys about physical activity, exercise anxiety, exercise efficacy, and fears about exercising\n* Perform fitness measures (6-minute walk test, balance tests, stand to sit tests, a 400 meter walk, and handgrip strength)\n* Attend at least 18 sessions of cardiac rehabilitation after they are randomized to their exercise prescription group\n* Wear a heart rate monitor and a physical activity monitor per study protocol\n\nParticipants will be randomized (flip of a coin) to either receive a graded exercise test and psychoeducational feedback or lifestyle education (nutrition for cardiac). The graded exercise test will be used to create a personalized exercise prescription with the target heart rate range calculated from the test and the lifestyle education group will use their ratings of perceived exertion for their exercise prescription.",[113,114,115,116,117],"Myocardial Infarction","Coronary Artery Bypass","Percutaneous Coronary Intervention","Heart Failure","Cardiac Valve Surgery","2025-07-04",{"date":120,"type":121},"2025-07-09","ACTUAL",{"date":123,"type":121},"2023-08-10",{"date":125,"type":107},"2027-06-30",{"name":5,"class":6},2]