Physical Activity and Functional Capacity in Patients With Congenital Long QT Syndrome

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo

About this trial

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.

This 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Confirmed diagnosis of congenital long QT syndrome, followed at the Arrhythmia Outpatient Clinic of the Heart Institute (InCor)

Signed informed consent

Disqualifiers

Acquired long QT syndrome

No diagnostic confirmation by clinical and/or genetic criteria, without the possibility of genetic testing as part of routine care

Corrected QT interval (QTc) persistently above 500 ms

Any implantable cardioverter-defibrillator (ICD) therapy or unexplained syncope in the previous 6 months

Trial population

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.

Trial design

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

  • Questionnaires

    Other intervention

    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.

  • Cardiopulmonary exercise testing

    Diagnostic test

    Treadmill ramp protocol with continuous metabolic, ventilatory and 12-lead electrocardiogram monitoring until exhaustion.

  • 24-hour Holter monitoring

    Diagnostic test

    Continuous 3-channel electrocardiogram recording for 24 hours.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Group 1: Congenital long QT syndrome3 interventions
Group B: Group 2: Arrhythmia with structurally normal heart3 interventions

Trial outcomes

Primary outcomes

1

Peak oxygen consumption (VO2 peak)

Baseline functional capacity measured as peak oxygen consumption (mL/kg/min) on cardiopulmonary exercise testing.

Time frame
At baseline (single assessment)

Secondary outcomes

1

Physical activity level

Weekly time spent walking and in moderate and vigorous physical activity, measured by the International Physical Activity Questionnaire short form (IPAQ).

Time frame
At baseline (single assessment)
2

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.

Time frame
At baseline
3

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.

Time frame
At baseline
4

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.

Time frame
At baseline

Other outcomes

Sponsors and contacts

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