[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659278":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":39,"studyPopulation":40,"armGroups":41,"interventions":53,"overallOfficials":36,"centralContacts":67,"locations":73,"responsibleParty":87,"collaborators":36,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":36,"enrollmentInfo":101,"targetDuration":36,"studyType":104,"phases":36,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":112,"whyStopped":36,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"University of Sao Paulo","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Peak oxygen consumption (VO2 peak)","Baseline functional capacity measured as peak oxygen consumption (mL\u002Fkg\u002Fmin) on cardiopulmonary exercise testing.","At baseline (single assessment)",[14,17,21,24,27,30,33],{"measure":15,"description":16,"timeFrame":12},"Physical activity level","Weekly time spent walking and in moderate and vigorous physical activity, measured by the International Physical Activity Questionnaire short form (IPAQ).",{"measure":18,"description":19,"timeFrame":20},"Quality of life Questionnaire","Physical and mental component scores of the 12-Item Short Form Health Survey (SF-12). Scores range from 0 to 100, with higher scores indicating better health-related quality of life.","At baseline",{"measure":22,"description":23,"timeFrame":20},"Proportion of patients who wish to engage in physical exercise","Proportion of participants answering yes to the question on willingness to practice physical exercise in the structured daily life questionnaire.",{"measure":25,"description":26,"timeFrame":20},"Reasons for not practicing physical exercise","Frequency of each reported reason for not exercising (medical advice, dislike, lack of time, arrhythmia diagnosis, defibrillator shock, device implantation) in the structured daily life questionnaire.",{"measure":28,"description":29,"timeFrame":20},"Association between physical activity level and arrhythmias","Association between physical activity level measured by the International Physical Activity Questionnaire (IPAQ) and the type and frequency of arrhythmias detected on 24-hour Holter monitoring and cardiopulmonary exercise testing.",{"measure":31,"description":32,"timeFrame":20},"Heart rate variability","Time-domain heart rate variability indices measured on 24-hour Holter monitoring.",{"measure":34,"description":35,"timeFrame":20},"Corrected QT interval during exercise and recovery","Corrected QT interval (QTc, ms) at rest (supine and standing), at peak exercise and during recovery on cardiopulmonary exercise testing.",null,{"allocation":36,"interventionModel":36,"interventionModelDescription":36,"primaryPurpose":36,"observationalModel":38,"timePerspective":6,"maskingInfo":36},"CASE_CONTROL","Background\n\nCongenital long QT syndrome (LQTS) is a genetically determined channelopathy characterized by delayed ventricular repolarization, which may cause syncope, ventricular arrhythmias and sudden cardiac death. The three most frequent subtypes, associated with variants in KCNQ1 (LQT1), KCNH2 (LQT2) and SCN5A (LQT3), account for about 90% of genotype-positive cases and have specific arrhythmic triggers: exercise in LQT1, auditory stimuli in LQT2 and rest in LQT3.\n\nPatients with LQTS have historically been advised against most sports. Recent American and European recommendations are less restrictive and favor shared decision-making, especially in asymptomatic genotype-positive, phenotype-negative individuals. Registry data suggest a low rate of sport-related events in athletes with LQTS who remain active under appropriate management, including beta-blocker therapy. On the other hand, children with LQTS have shown lower peak oxygen consumption and ventilatory anaerobic threshold than healthy controls, possibly due to beta-blocker-induced chronotropic limitation and deconditioning. There are no data on the physical activity profile and functional capacity of patients with LQTS followed in Brazilian clinical practice.\n\nThe Channelopathies Movement and Exercise Study (CANMOVE) is a broader initiative to analyze physical activity in patients with cardiac channelopathies. This project is its first step, focused on congenital LQTS.\n\nStudy design\n\nSingle-center observational study at the Heart Institute (Instituto do Coração, InCor), Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo, Brazil. The study combines a historical cohort, with physical activity data partially obtained from a previously approved study on physical activity in patients with cardiac arrhythmias (SDC 5310\u002F21\u002F085), and prospective inclusion of new patients with LQTS during the study period. The control group will consist of patients with cardiac arrhythmias and a structurally normal heart already included in the previous study, selected by propensity score matching.\n\nProcedures\n\n1. Questionnaires: the International Physical Activity Questionnaire short form (IPAQ), validated for the Brazilian population; the 12-Item Short Form Health Survey (SF-12) for quality of life; and a structured questionnaire on daily life after diagnosis of arrhythmia or device implantation, including reasons for not exercising and the desire to engage in physical exercise. Questionnaires will be applied before the outpatient visit.\n2. Resting 12-lead electrocardiogram (ECG): heart rate, baseline corrected QT interval (QTc) by Bazett's formula and presence of T-wave notching in at least three contiguous leads. Diagnosis of LQTS will follow the criteria of the 2022 European Society of Cardiology (ESC) guidelines for ventricular arrhythmias and prevention of sudden cardiac death.\n3. Cardiopulmonary exercise testing (CPET): treadmill ramp protocol with continuous metabolic, ventilatory and 12-lead ECG monitoring until exhaustion. Variables include peak oxygen consumption (VO2 peak), ventilatory anaerobic threshold, respiratory compensation point, heart rate and blood pressure responses, and QTc at rest (supine and standing, with orthostatic provocation), at peak exercise and during recovery.\n4. 24-hour Holter monitoring: continuous 3-channel ECG recording for arrhythmia detection and heart rate variability (HRV) analysis.\n5. Genetic testing: next-generation sequencing (NGS) panel including genes associated with LQTS, with variant classification according to the American College of Medical Genetics and Genomics (ACMG) criteria and discussion by a multidisciplinary group. Genetic data will be obtained from the clinical database of the Arrhythmia Unit.\n\nAll prospective participants will undergo CPET and 24-hour Holter monitoring using a standardized protocol for patients with LQTS. Beta-blocker therapy and other treatments (antiarrhythmic drugs, implantable cardioverter-defibrillator \\[ICD\\], sympathectomy) will be recorded. Data will be collected from electronic medical records and stored in the Research Electronic Data Capture (REDCap) platform.\n\nStatistical analysis\n\nApproximately 60 patients with congenital LQTS are expected. Categorical variables will be presented as absolute and relative frequencies, and continuous variables as mean and standard deviation or median and interquartile range. Patients with LQTS will be compared with controls matched by propensity score, calculated by logistic regression. Associations between categorical variables will be assessed by chi-square or Fisher's exact test, and continuous variables will be compared by Student's t test or Mann-Whitney test, according to distribution. P values below 0.05 will be considered statistically significant.","Adults with congenital long QT syndrome followed at the Arrhythmia Outpatient Clinic of the Heart Institute (InCor), Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo, Brazil. Controls are patients with cardiac arrhythmias and a structurally normal heart from the same institution.",[42,49],{"label":43,"type":36,"description":44,"interventionNames":45},"Group 1: Congenital long QT syndrome","Adults with a confirmed diagnosis of congenital long QT syndrome (LQTS) by clinical and\u002For genetic criteria, followed at the Arrhythmia Outpatient Clinic of the Heart Institute (InCor).",[46,47,48],"Other: Questionnaires","Diagnostic Test: Cardiopulmonary exercise testing","Diagnostic Test: 24-hour Holter monitoring",{"label":50,"type":36,"description":51,"interventionNames":52},"Group 2: Arrhythmia with structurally normal heart","Patients with cardiac arrhythmias and a structurally normal heart from a previous study on physical activity in patients with cardiac arrhythmias, selected by propensity score matching.",[46,47,48],[54,58,63],{"type":6,"name":55,"description":56,"armGroupLabels":57,"otherNames":36},"Questionnaires","International Physical Activity Questionnaire short form (IPAQ), 12-Item Short Form Health Survey (SF-12) and structured questionnaire on daily life and barriers to physical activity.",[43,50],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":36},"DIAGNOSTIC_TEST","Cardiopulmonary exercise testing","Treadmill ramp protocol with continuous metabolic, ventilatory and 12-lead electrocardiogram monitoring until exhaustion.",[43,50],{"type":59,"name":64,"description":65,"armGroupLabels":66,"otherNames":36},"24-hour Holter monitoring","Continuous 3-channel electrocardiogram recording for 24 hours.",[43,50],[68],{"name":69,"role":70,"phone":71,"phoneExt":36,"email":72},"Savia Bueno, MD, PhD","CONTACT","+55 11 2661-5341","savia_bueno@hotmail.com",[74],{"facility":75,"status":36,"city":76,"state":76,"zip":36,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Heart Institute","São Paulo","Brazil","BR",{"type":80,"coordinates":81},"Point",[82,83],-46.63611,-23.5475,{"lat":83,"lon":82},[86],{"name":69,"role":70,"phone":71,"phoneExt":36,"email":72},{"type":88,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Savia Christina Pereira Bueno","Principal Investigator","100659278","physical-activity-and-functional-capacity-in-patients-with-congenital-long-qt-syndrome-100659278",false,"NCT07862491","Physical Activity and Functional Capacity in Patients With Congenital Long QT Syndrome","Physical Activity Analysis in a Cohort of Patients With Congenital Long QT Syndrome: First Steps of the Channelopathies Movement and Exercise Study (CANMOVE)","CANMOVE","Inclusion Criteria:\n\n* Age 18 years or older\n* Confirmed diagnosis of congenital long QT syndrome, followed at the Arrhythmia Outpatient Clinic of the Heart Institute (InCor)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Acquired long QT syndrome\n* No diagnostic confirmation by clinical and\u002For genetic criteria, without the possibility of genetic testing as part of routine care\n* Corrected QT interval (QTc) persistently above 500 ms\n* Any implantable cardioverter-defibrillator (ICD) therapy or unexplained syncope in the previous 6 months\n* Bedridden patients or patients with walking difficulties\n* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or higher\n* Non-adherence to drug treatment\n* Advanced-stage disease with estimated survival of less than 1 year\n* Advanced cognitive impairment or inability to answer the questionnaires","ALL","18 Years",{"count":102,"type":103},120,"ESTIMATED","OBSERVATIONAL","Patients with congenital long QT syndrome (LQTS) have traditionally been discouraged from physical activity and competitive sports, although the rate of exercise-related arrhythmic events is considered low. In recent years, international guidelines have become less restrictive and now support shared decision-making between physicians, patients and families to promote safe physical activity. Excessive restriction, especially in young people, may negatively affect mental health, quality of life and overall cardiovascular risk. However, little is known about the physical activity level and physical fitness of patients with LQTS in clinical practice.\n\nThis observational study will describe the baseline functional capacity, physical activity level and quality of life of adults with congenital LQTS followed at the Arrhythmia Outpatient Clinic of the Heart Institute (InCor), São Paulo, Brazil, and compare them with patients with arrhythmias and a structurally normal heart. Participants will answer questionnaires on physical activity, quality of life and barriers to exercise, and will undergo cardiopulmonary exercise testing and 24-hour Holter monitoring. This is the first step of the Channelopathies Movement and Exercise Study (CANMOVE).",[107,108],"Long QT Syndrome","Channelopathies",[110,111],"Congenital long QT syndrome","Physical activity","NOT_YET_RECRUITING","2026-10-01",{"date":115,"type":116},"2026-10-07","ACTUAL",{"date":118,"type":103},"2026-11",{"date":120,"type":103},"2028-11",{"name":5,"class":6},1]