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

NCT07420088 | Not Yet Recruiting

• 2 other identifiers: 2025-23Hitit University
• Study Type: observational
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure; Cardiac Implantable Electrical Devices; Physical Activities

Keywords

Cardiac implantable electronic device; physical activity; seasonal variation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (2)

• Participant's functional capacity

  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

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

Study Arms (1)

Patients with Heart Failure with Cardiac Implantable Electronic Devices

Other: follow-up study

Interventions

follow-up study OTHER

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

Patients with Heart Failure with Cardiac Implantable Electronic Devices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with heart failure with cardiac implantable electrical devices

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erol Olcok Corum Training and Research Hospital: lead

Related Publications (1)

• Shoemaker MJ, Kampfschulte A, Rustmann S, Dickinson MG. 2021. '' Dynamic factor analysis of seasonal variation in daily physical activity in individuals with heart failure and implanted cardiac devices'', Heart and Lung, 50(6), 754-62.

  BACKGROUND

MeSH Terms

Conditions

Heart Failure; Motor Activity

Interventions

Follow-Up Studies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Cohort Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Gamze Nur Ahiskali, PT, MSc.

CONTACT

+905514128687; gmzahiskali@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, MSc. Gamze Nur Ahiskali

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 19, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): March 2, 2027
• Study Completion (Estimated): March 2, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share