Seasonal Physical Activity in Patients With Heart Failure With Cardiac Implantable Electronic Devices

N/ANot Yet RecruitingNCT07420088

Erol Olcok Corum Training and Research Hospital24 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Heart Failure Cardiac Implantable Electrical Devices Physical Activities

Interventions

follow-up studyOTHER

Seasonal variations in physical activity will be objectively investigated in heart failure patients with implantable cardiac electronic devices.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

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.

Time frame: Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter)

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.

Time frame: Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter)

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.

Time frame: Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter)

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.

Time frame: Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter)

Central Contacts

Gamze Nur Ahiskali, PT, MSc.

CONTACT

+905514128687 gmzahiskali@gmail.com

Data from ClinicalTrials.gov

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