Cardiac Implantable Electrical Devices, Heart Failure, Physical Activities
Conditions
Keywords
Cardiac implantable electronic device, physical activity, seasonal variation
Brief summary
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.
Interventions
Seasonal variations in physical activity will be objectively investigated in heart failure patients with implantable cardiac electronic devices.
Sponsors
Study design
Eligibility
Inclusion criteria
* 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.
Exclusion criteria
* 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, * Having a history of more than five hospitalizations for any reason, * Having recently undergone major cardiovascular or orthopedic surgical procedures, including coronary artery bypass grafting, aortic aneurysm repair, joint replacement, amputation, or spinal surgery, * Having a cognitive impairment that impairs cooperation with questionnaires or tests.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant's objective physical activity level | Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter) | 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 | Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter) | 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
| Measure | Time frame | Description |
|---|---|---|
| Participant's functional capacity | Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter) | 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 | Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter) | 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. |
Countries
Turkey (Türkiye)