[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07214350":3,"trial-entities:NCT07214350":87,"trial-summary:NCT07214350":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":19,"study_type":22,"primary_purpose":14,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":28,"secondary_outcomes":33,"sex":38,"minimum_age":39,"maximum_age":14,"healthy_volunteers":40,"eligibility_criteria":41,"std_ages":56,"locations":59,"central_contacts":75,"overall_officials":81,"references":85,"see_also_links":86},"NCT07214350","Pro00118596","Sex Differences in Barriers and Participation in Physical Activity During and Following Cardiac Rehabilitation","RECRUITING","2030-08","2025-12","2025-12-03","2025-12-02","Duke University","OTHER",null,"The SPARC study will measure physical activity and functional fitness during cardiac rehabilitation, right after completion of cardiac rehabilitation, and 6 months later. This will help investigators learn if men and women maintain physical activity levels and functional fitness differently during and after they complete cardiac rehabilitation. Participants in this study will have three in-person study visits and may complete two qualitative interviews over a 10-month study period. The greatest risks during the study include physical discomfort, falling, and\u002For shortness of breath during the fitness testing.",[17,18],"Cardiac Rehabilitation","Heart Disease",[20,21],"Physical Activity","Sex Differences","OBSERVATIONAL",[],{"count":25,"type":26},150,"ESTIMATED",[],[29],{"measure":30,"description":31,"timeFrame":32},"Average Daily Step Count","Calculated as an average of daily steps achieved over the previous week at each timepoint.","Baseline, 3 months, 9 months",[34],{"measure":35,"description":36,"timeFrame":37},"Average moderate-to-vigorous physical activity minutes per week","Self-reported moderate-to-vigorous-intensity physical activity minutes per week using the Paffenbarger Physical Activity Questionnaire.","9 months","ALL","18 Years",false,{"inclusion":42,"exclusion":46,"raw_text":55},[43,44,45],"Age \\> 18 years","Enrolled in cardiac rehabilitation within the last month","Own a smartphone or tablet for mobile application download",[47,48,49,50,51,52,53,54],"Planned relocation during the study period out of the local area","Planned medical procedure within the study period that may limit physical activity (i.e., joint replacement)","End-stage kidney disease","Impairment from stroke, injury, or other medical conditions that would prevent participation in or completion of the protocol","Heart transplant","Use of a left ventricular assist device","Pregnant or intending to become pregnant during the study period","Any other illness that, in the opinion of the study physician, would negatively impact or mitigate participation in or completion of the protocol","Inclusion Criteria:\n\n* Age \\> 18 years\n* Enrolled in cardiac rehabilitation within the last month\n* Own a smartphone or tablet for mobile application download\n\nExclusion Criteria:\n\n* Planned relocation during the study period out of the local area\n* Planned medical procedure within the study period that may limit physical activity (i.e., joint replacement)\n* End-stage kidney disease\n* Impairment from stroke, injury, or other medical conditions that would prevent participation in or completion of the protocol\n* Heart transplant\n* Use of a left ventricular assist device\n* Pregnant or intending to become pregnant during the study period\n* Any other illness that, in the opinion of the study physician, would negatively impact or mitigate participation in or completion of the protocol",[57,58],"ADULT","OLDER_ADULT",[60],{"facility":61,"status":7,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":72},"Duke Center for Living","Durham","North Carolina","27705","United States",[67],{"name":68,"role":69,"phone":70,"email":71},"Katherine A Collins-Bennett, PhD","CONTACT","919-479-2368","katherine.collins-bennett@duke.edu",{"lat":73,"lon":74},35.99403,-78.89862,[76,77],{"name":68,"role":69,"phone":70,"email":71},{"name":78,"role":69,"phone":79,"email":80},"Johanna L. Johnson, MS","919-660-6766","johanna.johnson@duke.edu",[82],{"name":83,"affiliation":12,"role":84},"Katherine A. Collins-Bennett, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":88,"biomarkers":90},[89],"Heart Disorder",[],{"nct_id":4,"found":92,"summary":93,"prompt_version":103},true,{"design":94,"status":95,"heading":96,"summary":97,"follow_up":98,"word_count":99,"commitments":100,"compensation":101,"drugs_mentioned":102},"This is an observational study planning to enroll 150 participants. It is not testing a specific treatment but rather observing physical activity levels.","completed","SPARC Study: Physical Activity After Cardiac Rehabilitation","The SPARC study is looking at how men and women maintain their physical activity levels and fitness during and after cardiac rehabilitation. This study doesn't test a new drug or intervention; instead, it observes participants' activity. Researchers want to understand if there are differences between sexes in how well people stay active after heart treatment. You might be able to join if you are over 18, have started cardiac rehabilitation within the last month, and own a smartphone or tablet. The main goal is to measure your average daily step count at the beginning, at 3 months, and at 9 months. The current recruitment status is unclear.","Your average daily step count will be measured at baseline, 3 months, and 9 months.",107,"You would have three in-person study visits and might complete two interviews over a 10-month period. You will also use a mobile application on your smartphone or tablet.","Not stated in the trial record.",[],"v2"]