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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07420088
Acronym
CIED
Enrollment
24
Registered
2026-02-19
Start date
2026-01-21
Completion date
2027-01-21
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Implantable Electrical Devices, Heart Failure, Physical Activities

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

OTHERfollow-up study

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

Sponsors

Erol Olcok Corum Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Participant's objective physical activity levelEvery 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 levelEvery 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

MeasureTime frameDescription
Participant's functional capacityEvery 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 activityEvery 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)

Contacts

CONTACTGamze Nur Ahiskali, PT, MSc.
gmzahiskali@gmail.com+905514128687

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026