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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorErol Olcok Corum Training and Research Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • follow-up study

    Other intervention

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

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Patients with Heart Failure with Cardiac Implantable Electronic Devices1 intervention

Trial outcomes

Primary outcomes

1

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)
2

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

1

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)
2

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)

Other outcomes

Sponsors and contacts

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