About this trial
The aim of this observational study is to determine the effect of seasonal changes on physical activity levels in heart failure patients with cardiac implantable electronic devices.
Patients with heart failure who have a cardiac implantable electronic device will be evaluated throughout the year.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Over 18 years of age,
Have a diagnosis of heart failure due to ischemic or non-ischemic cardiomyopathy,
Have a cardiac implantable electrical devices,
Be in New York Heart Association (NYHA) Class I-II-III.
Disqualifiers
Being a New York Heart Association (NYHA) Class IV resident
Not living within a 50-mile radius of a weather reporting station,
Having documented conditions that limit ambulation, including wheelchair use, serious orthopedic problems, stroke and other neurological disorders, or amputation,
Using a left ventricular assist device,
Trial population
Patients with heart failure with cardiac implantable electrical devices
Trial design
Cohort
Prospective
Treatments tested in this trial
follow-up study
Other interventionSeasonal variations in physical activity will be objectively investigated in heart failure patients with implantable cardiac electronic devices.
Treatment groups
Trial outcomes
Primary outcomes
Participant's objective physical activity level
Objective measurement of physical activity will be assessed using an accelerometer (Garmin Vivosmart 5). The accelerometer will be placed on the patient's non-dominant wrist for one week, 5 days a week during weekdays and 2 days a week on weekends. The accelerometer can be used day and night, while sleeping or showering, and has enough battery life to collect activity data throughout the day.
Participant's subjective physical activity level
Additionally, physical activity will be assessed using International Pyhsical Activity Questionnaire Short Form (IPAQ). The questionnaire examines physical activity in four different groups: vigorous physical activity, moderate physical activity, walking, and sitting. In the results evaluation, the data is converted to metabolic rate (MET) values and calculated accordingly.
Secondary outcomes
Participant's functional capacity
The maximal symptom-limited Cardiopulmonary Exercise Test (CPET), the gold standard method for assessing functional capacity, will be used.
Participant's motivation for physical activity
This 16-item scale includes individual, environmental, and irrational dimensions that influence participation motivation. The total score changes between 16 and 80. Higher scores indicate higher motivation for participating in physical activity.
Sponsors and contacts
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