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NCT Number: NCT07420088

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

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.

Recruiting

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Key information

Conditions

Heart Failure Behavior Cardiac Implantable Electrical Devices Cardiovascular Diseases Heart Diseases Motor Activity Physical Activities

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hitit University Erol Olcok Training and Research Hospital

Çorum, Turkey (Türkiye)

Location status: Recruiting

Location contact

Gamze Nur AHISKALI

CONTACT

[email protected]

905514128687

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

follow-up study

Other

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

Primary outcomes

  1. Participant's objective physical activity level

    Time frame: 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.

  2. Participant's subjective physical activity level

    Time frame: 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 outcomes

  1. Participant's functional capacity

    Time frame: 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.

  2. Participant's motivation for physical activity

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gamze Nur Ahiskali, PT, MSc.

CONTACT

[email protected]

+905514128687

Sponsors and collaborators

Lead sponsor

Erol Olcok Corum Training and Research Hospital

Other

Registry information

Official study title

The Effect of Seasonal Variation on Physical Activity in Patients With Heart Failure With Cardiac Implantable Electronic Devices

Acronym: CIED

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 19, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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